Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized,double-blind,placebo-controlled trial

Constipation is among the most common health impairments in Western countries. This study aimed to determine the effect of the chicory-derived fermentable dietary fiber Orafti^® Inulin on stool frequency in healthy subjects with constipation. The study was conducted according to recent guidance documents for investigating bowel function and used a randomized, double-blind, placebo-controlled, cross-over design with a 2-week wash-out phase. Each study period comprised a run-in phase followed by 4 weeks daily intake of 3?×?4g inulin or maltodextrin (placebo). Forty-four healthy volunteers with constipation documented stool frequency and consistency, gastrointestinal characteristics and quality of life. Consumption of Orafti^® Inulin significantly increased stool frequency compared to placebo (median 4.0 [IQR 2.5–4.5] versus 3.0 [IQR 2.5–4.0] stools/week, p?=?0.038). This was accompanied by a softening of stools and trend toward higher satisfaction versus placebo (p?=?0.059). In conclusion, Orafti^® Inulin was effective in volunteers with chronic constipation and significantly improved bowel function.

Clinical trial registration: This trial was registered at clinicaltrials.gov as NCT02548247.     

A randomized, double-blind placebo-controlled trial evaluating the effects of vitamin E and selenium on arsenic-induced skin lesions in Bangladesh

OBJECTIVE: We sought to determine whether supplementation of vitamin E (alpha-tocopherol), selenium (L-selenomethionine), or their combination improves arsenical skin lesions. METHODS: A 2 x 2 randomized, placebo-controlled, double-blind trial among 121 men and women chronically exposed to arsenic in drinking water was conducted in rural Bangladesh. Participants were randomized to one of four treatment arms: vitamin E, selenium, vitamin E and selenium (combination), or placebo and were treated for 6 months. RESULTS: At baseline, the average skin lesion scores were 2.23, 2.26, and 2.63 and at follow-up, the average skin lesion scores went down to 2.00, 2.06, and 2.47 in those receiving vitamin E, selenium, and the combination, respectively. CONCLUSIONS: Supplementation with vitamin E and selenium, either alone or in combination, slightly improved skin lesion status, although the improvement was not statistically significant.     

Effects of vitamin C and vitamin E on in vivo lipid peroxidation: results of a randomized controlled trial

BACKGROUND: Lipid peroxidation may be important in the pathogenesis of atherosclerosis, particularly in its earliest stages. Evidence predominantly from in vitro studies suggests that antioxidant vitamins can prevent lipid peroxidation and that vitamin C and vitamin E have synergistic effects. However, in vivo evidence in support of these hypotheses is sparse. OBJECTIVE: The objective was to determine the effects of vitamin C and vitamin E, alone or in combination, on in vivo lipid peroxidation. DESIGN: We conducted a placebo-controlled, 2 x 2 factorial trial of vitamin C (500 mg ascorbate/d) and vitamin E (400 IU RRR-alpha-tocopheryl acetate/d) supplementation in 184 nonsmokers. The mean duration of supplementation was 2 mo. The outcome measures were changes from baseline in urinary 8-iso-prostaglandin F(2alpha), urinary malondialdehyde + 4-hydroxyalkenals, and serum oxygen-radical absorbance capacity. RESULTS: The within-group mean changes (and 95% CIs) in urinary 8-iso-prostaglandin F(2alpha) (pg/mg creatinine) were 9.0 (-125.1, 143.1), -150.0 (-275.4, -24.6), -141.3 (-230.5, -52.1), and -112.5 (-234.8, 9.8) in the placebo, vitamin C alone, vitamin E alone, and vitamins C + E groups, respectively. No synergistic effect of these 2 vitamins on urinary 8-iso-prostaglandin F(2alpha) was observed (P = 0.12). Neither vitamin had an effect on urinary malondialdehyde + 4-hydroxyalkenals. Vitamin C, but not vitamin E, increased serum oxygen-radical absorbance capacity (P = 0.01). CONCLUSIONS: Supplementation with vitamin C or vitamin E alone reduced lipid peroxidation to a similar extent. Supplementation with a combination of vitamins C and E conferred no benefit beyond that of either vitamin alone.     

Effect of calcium supplementation on fracture risk: a double-blind randomized controlled trial

BACKGROUND: The effect of supplementation with calcium alone on risk fractures in a healthy population is not clear. OBJECTIVE: The objective was to determine whether 4 y of calcium supplementation would reduce the fracture risk during treatment and subsequent follow-up in a randomized placebo-controlled trial. DESIGN: The participants were aged <80 y at study entry (mean age: 61 y), were generally healthy, and had a recent diagnosis of colorectal adenoma. A total of 930 participants (72% men; mean age: 61 y) were randomly assigned to receive 4 y of treatment with 3 g CaCO(3) (1200 mg elemental Ca) daily or placebo and were followed for a mean of 10.8 y. The primary outcomes of this analysis were all fractures and minimal trauma fractures (caused by a fall from standing height or lower while sitting, standing, or walking). RESULTS: There were 46 fractures (15 from minimal trauma) in 464 participants in the calcium group and 54 (29 from minimal trauma) in 466 participants in the placebo group. The overall risk of fracture differed significantly between groups during the treatment phase [hazard ratio (HR): 0.28; 95% CI: 0.09, 0.85], but not during the subsequent posttreatment follow-up (HR: 1.10; 95% CI: 0.71, 1.69). Minimal trauma fractures were also less frequent in the calcium group during treatment (HR: 0; 95% CI: 0, 0.50). CONCLUSION: Calcium supplementation reduced the risk of all fractures and of minimal trauma fractures among healthy individuals. The benefit appeared to dissipate after treatment was stopped. This trial was registered at clinicaltrials.gov as NCT00153816.     

Effect of five-year supplementation of vitamin C on serum vitamin C concentration and consumption of vegetables and fruits in middle-aged Japanese: a randomized controlled trial

OBJECTIVE: This study was aimed at evaluating the effect of long-term vitamin C supplementation on serum and dietary vitamin C and identifying the factors associated with change in serum concentration. METHODS: A total of 439 subjects with atrophic gastritis initially participated in a randomized clinical trial using vitamin C and beta-carotene to prevent gastric cancer. We originally randomized the participants into four treatment groups using a 2x2 factorial design, whereby 0 or 15 mg/day beta-carotene and 50 or 500 mg/day vitamin C were administered in a double-blind manner. The beta-carotene component was terminated early after a mean treatment duration of four months. Before and upon early termination of beta-carotene supplementation, 134 subjects dropped out this trial, while 120 and 124 subjects took the vitamin C supplement at either 50 mg or 500 mg daily for five years. RESULTS: Changes in serum vitamin C were significantly higher in the high-dose group (38.5% increase, 95% CI = 27.0-49.9) than in the low-dose group (13.0% increase, 5.1-20.9) or in the dropout group (3.3% increase, -2.1-8.6) after five-year supplementation. The serum vitamin C at baseline was negatively associated with changes in serum vitamin C (p < 0.0001), while high-dose (p < 0.0001) and low-dose (p < 0.05) supplementation and female gender (p < 0.001) were positively associated. Dietary intake of vitamin C in the supplementation group was almost identical before and after five-year supplementation of vitamin C (2.31 mg/day decrease, 95% CI = -15.3-10.7), while a 17.7 mg/day decrease (95% CI = -44.2-8.86) was observed in the drop-out group. CONCLUSION: Five-year vitamin C supplementation induces a remarkable increase in serum vitamin C concentration, and our intervention program appears to have no effect on dietary vitamin C intake.     

Effect of long-term fish oil supplementation on vitamin E status and lipid peroxidation in women.

Fifteen young (22-35 y) and 10 older (51-71 y) women received six capsules of fish oil (Pro-Mega)/d, providing a total of 1,680 mg eicosapentaenoic (EPA), 720 mg docosahexaenoic (DHA), 600 mg other fatty acids, and 6 IU vitamin E. Blood was collected before and after 1, 2 and 3 mo of supplementation. Compliance was confirmed by the significant increase in plasma EPA and DHA in all women. Older women had a significantly higher increase in EPA and DHA than did young women (10-fold increases in EPA and 2.5-fold increases in DHA vs. 8-fold in EPA and 2-fold in DHA for older and young women, respectively). The decrease in the arachidonic acid:EPA ratio was more dramatic in the older women. Plasma total triglycerides (TG) decreased significantly, and the ratio of polyunsaturated fatty acids to saturated fatty acids was significantly (P less than 0.01) increased. Plasma vitamin E levels did not change significantly after supplementation; however, after 3 mo of supplementation by young women, plasma vitamin E was significantly lower than after 1 mo. The vitamin E: TG ratio was significantly increased and vitamin E:(EPA + DHA) significantly decreased. All women showed a significant increase in plasma lipid peroxide through mo 2 of supplementation. After 2 mo, older women had significantly higher lipid peroxide levels than young women. The lipid peroxide:TG ratio, which declined by mo 3, was still significantly higher than baseline. These data indicate that although long-term fish oil supplementation may be beneficial in reducing plasma total TG, susceptibility of plasma lipids to free radical attack is potentiated.(ABSTRACT TRUNCATED AT 250 WORDS)     

Raloxifene and tibolone in elderly women: a randomized, double-blind, double-dummy, placebo-controlled trial

ObjectivesThe authors’ first aim was to study the effects of raloxifene and tibolone on body mass density, handgrip strength, and other secondary frailty components. The secondary aim was to compare the effects of raloxifene and tibolone and their safety in older women.Design/Setting/ParticipantsA randomized, double-blind, double- dummy, placebo-controlled trial conducted in an academic hospital in the Netherlands among 318 community living women aged >70 were randomized; 290 received the allocated intervention: 97 placebo, 101 raloxifene, and 92 tibolone.InterventionsRandomization was made to raloxifene 60 mg, tibolone 1.25 mg, or placebo. Assessments were performed at baseline and after 3, 6, 12, and 24 months. The study was conducted from July 2003 to January 2008. The tibolone group stopped earlier in February 2006, because of results of the Long-Term Intervention on Fractures with Tibolone study, suggesting an increased risk of cerebrovascular accident.MeasurementsPrimary endpoints were body mass density and handgrip strength. Secondary endpoints were muscle power and strength, mobility measures, body composition, verbal memory, mental processing speed, anxiety, mood, and quality of life.ResultsTibolone and raloxifene had similar body mass density-effect sizes (d = .24–.47), and had no effect on handgrip muscle strength. For the 15 words test the effect on direct recall of concrete and abstract words (d = .40 and d =.27, respectively) and on delayed recall of concrete words (d = .77) were significantly higher in the raloxifene group compared to placebo and to tibolone. In the raloxifene group the health status (EuroQol VAS (0–100) was improved 2.4 points [95% CI 0.5–4.2; P = .012] over 24 months.ConclusionIn women >70 years old, raloxifene and tibolone significantly and similarly increased body mass density but not muscle strength. Raloxifene had also positive effects on verbal memory and health status. New research with selective estrogen receptor modulators like raloxifene might be promising on frailty endpoints in elderly women.Trial registration numberNederlands Trial Register: 1232     

Vitamin E and ginseng supplementation to enhance female sexual function: a randomized,double-blind,placebo-controlled,clinical trial

ABSTRACT

Female sexual disorders (FSD) are a spectrum of disorders common among women, especially in their middle age, which can reduce the female quality of life substantially. We aimed to evaluate the effects of a combined vitamin E and ginseng supplement on amelioration of female sexual dysfunction. In a 6-week, double-blind, randomized, placebo-controlled clinical trial, participants, suffering from sexual dysfunction based on the female sexual function index (FSFI) questionnaire, were randomly allocated to receive the supplement (100 IU vitamin E, 67 mg Korean ginseng, and 40 mg Siberian ginseng) or placebo daily. The primary outcome in our trial was the change in the FSFI total score. Sixty-nine participants were enrolled, but only 31 in each group completed the trial. Changes in the FSFI total score and its domain scores were significant during the trial course within each group. However, the supplement only ameliorated desire and satisfaction domains superior to the placebo. In case of the total score and other domains, the changes were insignificantly different between the treatment groups. Although our study could not find additional benefits for the vitamin E and ginseng supplement over placebo in enhancing sexual function overall, the supplement worked better in enhancing sexual desire and satisfaction.     

Effect of vitamin C on common cold: randomized controlled trial

OBJECTIVE: To investigate the relationship between the common cold and vitamin C supplementation. DESIGN: A double-blind, 5-year randomized controlled trial. SETTING: A village in Akita prefecture, one of the regions in Japan with the highest mortality from gastric cancer. SUBJECTS: Participants in annual screening programs for circulatory diseases conducted under the National Health and Welfare Services Law for the Aged, and diagnosed as having atrophic gastritis. Of the 439 eligible subjects, 144 and 161 were assigned to receive 50 or 500 mg of vitamin C, respectively, after protocol amendment. During the supplementation phase, 61 dropped out, and 244 completed the trial. Intervention: Daily vitamin C supplementation of 50 mg (low-dose group) or 500 mg (high-dose group). RESULTS: Total number of common colds (per 1000 person-months) was 21.3 and 17.1 for the low- and high-dose groups, respectively. After adjustment for several factors, the relative risks (95% confidence interval (CI)) of suffering from a common cold three or more times during the survey period was 0.34 (0.12-0.97) for the high-dose group. No apparent reduction was seen for the severity and duration of the common cold. CONCLUSION: A randomized, controlled 5-year trial suggests that vitamin C supplementation significantly reduces the frequency of the common cold but had no apparent effect on the duration or severity of the common cold. However, considering several limitations due to protocol amendment, the findings should be interpreted with caution.     

Effect of nutritional supplements on wound healing in home-nursed elderly: a randomized trial

OBJECTIVE: The objective was to determine whether provision of oral nutritional supplements, delivered by community nurses, could improve nutritional status and wound healing in home-nursed elderly. METHODS: This was a double-blind, randomized trial in 50 elderly patients referred for wound management. Patients received 237 mL/d of 4 or 8 kJ/mL of an oral nutritional supplement for 4 wk. Nutritional status was measured with the Subjective Global Assessment and the Mini-Mental State Examination questionnaire to determine cognitive function and wound characteristics to assess healing. Differences between variables were examined with the Mann-Whitney or Student's t test for comparing two groups, one-way analysis of variance when there was more than two groups, and chi-square analysis for comparing two categorical variables. Associations between variables were examined with Pearson's correlation and regression analysis. RESULTS: At baseline, 34% subjects were moderately malnourished and 8% were severely malnourished. In both groups, there was significantly greater improvement in Mini-Mental State Examination scores at week 4 (95% confidence interval -2.0 to -0.001, P = 0.04) and a greater decrease in the wound effusion score (95% confidence interval -2.0 to 0.0, P = 0.045). Median length of stay did not differ between groups (P > 0.05). CONCLUSIONS: Malnutrition is common in elderly patients who are nursed at home for wound management. Provision of energy- and protein-dense oral supplements by community nurses is effective in improving some indices of wound healing and cognitive function in this group. Although further study is needed to determine the effect on length of stay, the nutritional needs of this vulnerable group should not be overlooked.     

The effect of perinatal fish oil supplementation on neurodevelopment and growth of infants: a randomized controlled trial

Introduction

Long-chain polyunsaturated fatty acids, the most abundant fatty acids in the brain, are essential for the growth and development of the brain and the retina.

Objective

To evaluate the effect of fish oil supplementation on the development (primary outcome) and growth of 4- and 6-month-old infants.

Methods

In this triple-blind randomized controlled trial, 150 pregnant women aged 18–35 years, who were referred to healthcare centres of Tabriz-Iran, were randomly allocated into two groups. One group of women consumed fish oil supplementation (containing 120 mg docosahexaenoic acid and 180 mg eicosapentaenoic acid) daily, while the other consumed a placebo from the 20th week of pregnancy till 30 days after childbirth in a parallel design by a computer-generated block randomization scheme. The neurodevelopment of infants was the primary outcome; it was assessed using the ages and stages questionnaire (ASQ) at 4- and a-6 months of age. The growth of these infants was measured using weight, length and head circumference. The participants, the caregivers, and those assessing the outcomes were blind to the group assignment.

Results

Only one woman in the placebo group discontinued the intervention because of persistent severe nausea. All 75 neonates aged 4- and a-6 months in the fish oil supplementation group, along with 73 and 71 neonates aged 4 and 6 months, respectively in the placebo group, were followed and analysed. Although the mean scores of neurodevelopment at the end of 4 and 6 months were higher in the supplemented group than in the placebo group in each ASQ domain, a statistically significant difference was observed only in the communication domain at the 4th month (adjusted mean difference 2.63; 95% confidence interval 0.36–4.89). There was no significant difference in weight, length, or head circumference between the two groups of infants aged 4 and 6 months (P ≥ 0.05).

Conclusion

Based on the results, perinatal fish oil supplementation is beneficial for the communication domain of neurodevelopment of 4-month-old infants. The study results relating to the supplementation effect on other domains are inconclusive. There ought to be further studies with up-to-date lipidomic analysis to find biochemical correlate compared to an intervention and developmental finding.

     

Health effects of fish oil and fish oil supplements: consumption advice sustained

Omega-3 fatty acids are thought to have beneficial effects on atherosclerosis. Recently, the results ofa systematic review on the health effects of omega-3 fatty acids were published. The risk of cardiovascular death in subjects randomised to taking omega-3 fats was not significantly decreased: relative risk = 0.87 (95% CI: 0.73-1.03). In a 2004 Cochrane review, the same authors concluded that there was a significant beneficial effect on total mortality, combined cardiovascular endpoints and cancer. Inclusion of the recent 'Diet and reinfarction trial' (DART-2-trial) had a decisive negative effect on the results of the recent meta-analysis. Excluding this study resulted in a relative risk of cardiovascular death of 0.83 (95% CI: 0.75-0.91). Since the DART-2 study had methodological shortcomings, it still appears that recommending sufficient intake of omega-3 fatty acids is justifiable, preferably by eating fish but ifnecessary by using fish oil supplements, especially for patients at high risk of cardiovascular disease.     

The effect of almonds on vitamin E status and cardiovascular risk factors in Korean adults: a randomized clinical trial

Purpose

Almonds have shown to beneficially modify some cardiovascular risk factors in clinical trials conducted in diverse ethnic populations but this relationship has never been tested in Koreans. Thus, we tested the impact of almonds consumed as a snack within the context of a typical Korean diet on cardiovascular risk factors.

Methods

We conducted a randomized, crossover trial in a free-living setting with a 2-week run-in period, two 4-week intervention phases, and a 2-week washout period between interventions. Eighty four overweight/obese participants (11 M/73 F; 52.4 ± 0.6 year; 25.4 ± 0.22 kg/m²) consumed either 56 g of almonds or isocaloric cookies daily for 4 weeks.

Results

Mean % daily energy intake at baseline was 64.8, 21.3, and 14.9% from carbohydrate, fat, and protein, respectively. The addition of 56 g of almonds daily decreased carbohydrate energy to 55.0%, increased fat to 32.0%, and maintained protein at 14.7%. Consuming the almonds increased intake of MUFA by 192.3%, PUFA by 84.5%, vitamin E by 102.7%, and dietary fiber by 11.8% and decreased % energy from carbohydrate by 14.1%. Total caloric intake was increased by the almonds, but body weight, waist circumference, and body composition were not affected. Almonds in overweight and obese Korean adults decreased TC, LDL-C, and non-HDL-C by 5.5, 4.6, and 6.4%, respectively, compared to the cookie control (P ≤ 0.05). Almonds increased plasma α-tocopherol by 8.5% (P ≤ 0.05) from the baseline and tended to increase its value as compared to cookies (P = 0.055). Neither the almonds nor cookies altered plasma protein carbonyls, MDA or oxLDL. Of serum inflammatory markers, IL-10 was decreased by almond intake (P ≤ 0.05), and ICAM-1, IL-1β, and IL-6 tended to be lower with almonds, compared to the cookies.

Conclusions

Almonds at 56 g/day consumed as a snack favorably modified the Korean diet by increasing MUFA, PUFA, vitamin E, and dietary fiber intake and decreasing % energy intake from carbohydrate. Almonds also enhanced plasma α-tocopherol status and serum TC and LDL-C in overweight and obese Koreans. Thus, including almonds in typical Korean diets as a snack can help healthy overweight/obese individuals improve nutritional status and reduce their risk for CVD.

     

The influence of a fish oil high in docosahexaenoic acid on plasma lipoprotein and vitamin E concentrations and haemostatic function in healthy male volunteers.

Nine healthy male subjects consumed a daily fish oil supplement providing 2.1 g docosahexaenoic acid (22:6 n-3; DHA) and 0.8 g eicosapentaenoic acid (20:5 n-3; EPA) for 6 weeks. The proportion of EPA and DHA in plasma, erythrocytes, leucocytes and platelet phospholipids was increased by the supplement. Plasma concentration of triacylglycerol and very-low-density-lipoprotein-cholesterol were lowered and those of high-density-lipoprotein (HDL)- and HDL2-cholesterol and apoprotein B were increased. Platelet aggregation and thromboxane B2 production induced by collagen were partially inhibited. Both systolic and diastolic blood pressure fell during treatment and rose following withdrawal of the supplement. Statistically significant reductions in erythrocyte counts, packed cell volume and haemoglobin and increases in total leucocyte and monocyte counts occurred with the supplement. Plasma alpha-tocopherol concentrations fell below the normal range during the period of supplementation. It is suggested that future studies consider components other than EPA in fish oil. Further studies are needed to investigate the extent to which fish oil increases the requirement for antioxidant nutrients.