Dataset Information

Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women.

ABSTRACT: Objective. To investigate the effect by which daily consumption of a novel red clover (RC) extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150?mL RC extract containing 37.1?mg isoflavones (33.8?mg as aglycones) or placebo. Methods. Bone parameters were changes in bone mineral density (BMD), bone mineral content (BMC), and T-score at the lumbar spine and femoral neck. Bone turnover (CTx) and inflammatory markers were measured in plasma and finally blood pressure (BP) was evaluated. Results. RC extract had positive effect on bone health, and only the women receiving the placebo experienced a decline in BMD (p < 0.01) at the lumbar spine. T-score at the lumbar spine only decreased in the placebo group (p < 0.01). CTx decreased in the RC group with -9.94 (±4.93)%, although not significant. Conclusion. Daily consumption of RC extract over a 12-week period was found to have a beneficial effect on bone health in menopausal women based on BMD and T-score at the lumbar spine and plasma CTx levels. No changes in BP or inflammation markers were found and no side effects were observed.

SUBMITTER: Thorup AC

PROVIDER: S-EPMC4523657 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women.

Thorup Anne Cathrine AC Lambert Max Norman MN Kahr Henriette Strøm HS Bjerre Mette M Jeppesen Per Bendix PB

Evidence-based complementary and alternative medicine : eCAM 20150721

Objective. To investigate the effect by which daily consumption of a novel red clover (RC) extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150 mL RC extract containing 37.1 mg isoflavones (33.8 mg as aglycones) or placebo. Methods. Bone parameters were changes in bone mineral density (BMD), bone mineral content ...[more]

PMID: 26265926

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Project description:The purpose of this study was to validate the efficacy of a customized vitamin-mineral supplement on blood biomarkers in pre-menopausal females. Women (21-40 years old) who were apparently healthy were recruited from the local community (ClinicalTrials.gov trial registration NCT03828097). Pretesting (PRE) occurred in the morning 5 ± 2 days following each participant's menses and involved a fasted blood draw, body mass assessment, and blood pressure assessment. Participants were then randomly assigned in a double-blinded fashion to either the multivitamins (MV) (n = 43) or placebo group (n = 51). Participants consumed two capsules per day with breakfast for 12 weeks. Following the trial, participants reported to the laboratory for POST assessments, which replicated PRE procedures. Red blood cell fatty acid and serum micronutrient analyses were performed in a blinded fashion at hematology laboratories. A group × time interaction was observed for serum vitamin D levels (p < 0.001). MV increased levels from PRE to POST (+43.7%, p < 0.001), whereas no change occurred in the placebo group. Additionally, 78% of MV participants at PRE exhibited inadequate vitamin D levels (<40 ng/dl), whereas only 30% exhibited levels below this threshold at POST. An interaction was also observed for serum folate levels (p < 0.001). MV increased serum folate from PRE to POST (p < 0.001), whereas no change occurred in the placebo group. Red blood cell omega-3 fatty acid content increased from PRE to POST in the MV group (p < 0.001) and placebo group (p < 0.05), although POST values were greater in the MV group (p < 0.001). An interaction was observed for serum HDL cholesterol levels (p = 0.047), and a non-significant increase in this variable from PRE to POST occurred in the MV group (p = 0.060). Four-day food recalls indicated MV increased intake of omega-3 fatty acids, vitamin D, folate, and other micronutrients. In summary, MV supplementation increased serum vitamin D, serum folate, and red blood cell omega-3 fatty acid levels. However, these data are limited to healthy females, and more research is needed to examine if MV can affect metabolic disturbances in individuals with micronutrient deficiencies.

Project description:Abstract Objectives We determined if multivitamin supplementation (MV) affected serum folate levels in women during a 12-week intervention, and if genotypes affected these outcomes. Methods Women (21–40 years old) were recruited from the local community. PRE testing occurred between 0600–0900 AM 5 ± 2 days following each participants’ last menstrual cycle, and involved a buccal cell collection and a fasted blood draw. Participants were then randomly assigned in a double-blinded fashion to the MV group (n = 43) or placebo group (n = 51). MV (per 2 beadlets-in-capsule serving) contained 50 mcg vitamin D3, 6.7 mg alpha tocopherol of vitamin E as mixed tocopherols, 90 μg vitamin K2 MK7, 600 μg 5-methyltetrahydrofolate, 8 μg B12, 8 mg iron, 50 mg magnesium, 1 mg boron, and 320 mg omega-3 fatty acids. The placebo capsules contained safflower oil and cellulose. Participants consumed two capsules per day with breakfast for 12 weeks. Following the intervention, participants reported to the laboratory for POST testing. Serum folate analyses were performed at a hematology laboratory (East Alabama Medical Center, Opelika, AL, USA). SNPs related to folate metabolism (MTHFR rs1801133, MTHFR rs1801131, MTHFR rs2274976, MTRR rs1801394) were interrogated using the Axiom PMDA.r6 array (Thermo Fisher Scientific, Waltham, MA, USA). Results A group × time interaction was observed for serum folate levels and dietary folate intake (P < 0.001). MV supplementation increased serum folate levels from PRE to POST (P < 0.001), whereas no change occurred in the placebo group (P = 0.345). MV supplementation also increased the PRE to POST intakes of folate (P < 0.001), whereas these values were not affected in the placebo group (P = 0.576). MV supplementation increased serum folate levels regardless of MTHFR genotype. The MTRR rs1801394 genotype showed a genotype x time interaction (P = 0.049); specifically, folate levels increased in the AG and AA genotypes (P < 0.05), but not the GG genotype (P = 0.080). Conclusions MV supplementation increases serum folate levels. While the interrogated MTRR genotype may play a role regarding the efficacy of MV supplementation, these data are preliminary given the limited n-size. Funding Sources Funding was provided to MDR, RRA, and KCY by Ritual, Inc. Support was also provided by The GHT Companies, and Kappa BioSciences.

Project description:BackgroundThe endocannabinoid system is active in nervous and immune cells and involves the expression of two cannabinoid receptor genes (CB1 and CB2), along with endogenous endocannabinoid ligands, 2-arachidonoyl glycerol (2-AG) and arachidonoyl ethanolamide (anandamide), and their synthetic enzymes. Cannabidiol (CBD) is a non-intoxicating exogenous cannabinoid agonist derived from plants that, at high doses, has received FDA approval as an anticonvulsant for epileptic seizures, and at low doses is marketed as a food-grade supplement for improved mental health, sleep quality, and immunological function. At present, the predominance of published CBD clinical research has focused on ameliorative or disease-specific intervention, with few trials investigating CBD effects in healthy populations.MethodsThis clinical study aimed to investigate the effects of 8 weeks of 50 mg oral CBD on mental health, sleep quantity and quality, and immune cell function in healthy, college-aged individuals. Twenty-eight participants (average age 25.9 ± 6.1 y) were randomized to receive either daily oral capsules of 50 mg of CBD (CB, n = 14) or a calorie-matched placebo (CN, n = 14). Participants completed pre- and post-intervention assessments, including anthropometric measurements, mental health surveys, sleep analysis, and immunological function assessments.ResultsAfter completing the 8-week intervention, there were no significant changes in body weight and BMI (CN: 1.09 ± 0.89%: CB: 1.41 ± 1.07%), or body fat percentage (CN: 9.01 ± 7.51%: CB: 8.57 ± 7.81%), respectively (values are % change pre to post, p > 0.05). There were also no significant differences between CB and CN groups with respect to mental health measures, sleep quantity, or circulating immunophenotype as a result of the intervention. However, the CB group experienced significant improvements in sleep quality measured objectively using a sleep questionnaire (p = 0.0023) and enhanced Natural Killer (NK) immune cell function assessed in situ (p = 0.0125).ConclusionsEight weeks of daily 50 mg CBD may improve sleep quality, and NK immunosurveillance in healthy, younger adults.

Dataset Information

Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women.

Publications

Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women.

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