Blackcurrant Modifies Gut Microbiota and Reduces Osteoporosis Risk

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    50
  • sponsor
    University of Connecticut
Updated on 20 August 2021
calcium
deficiency
vitamin d
bone scan
vitamin d deficiency
osteoporosis risk
bone scans

Summary

Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome and bone mass in adult women.

Description

Postmenopausal bone loss is a primary contributor to osteoporosis and osteoporotic fractures in adult women. Overall goal of this project is to evaluate the effects of blackcurrant (BC) supplementation on changes in gut microbiome and bone mass in adult women. For this purpose, the investigators will conduct a pilot randomized placebo-controlled clinical trial with BC supplementation for 6 months in peri- and early postmenopausal women aged 45-60 years.

The primary endpoint will be lumbar spine bone mineral density (BMD); secondary endpoints will be gut microbial Firmicutes/Bacteroidetes (F/B) ratio. To delineate the underlying mechanisms of the action, changes in biomarkers for bone metabolism, bone-related immune and endocrine systemic biomarkers by BC supplementation will be measured in plasma and peripheral blood derived mononuclear cells.

The specific objectives of the study are to investigate the effects of BC extract on: 1) bone mass and bone remodeling markers; 2) changes in the gut microbiota abundance and composition, immune and endocrine biomarkers and their relationships with changes in bone mass.

The proposed study will provide novel insight into whether and how BC consumption reduces the risk of postmenopausal bone loss in adult women and will improve understanding of the clinical roles of gut microbiome in postmenopausal bone loss. Findings from this study will help increase awareness of the bone health promoting effect of BC and motivate increased production of BC and other berry products in response to the increasing consumer demand.

Details
Condition Osteoporosis, Postmenopausal osteoporosis, Gut Microbiota
Treatment blackcurrant (BC) extract
Clinical Study IdentifierNCT04431960
SponsorUniversity of Connecticut
Last Modified on20 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

perimenopausal or early postmenopausal women aged 45-60 years old
not on HRT for at least one year before the initiation of the study
maintaining normal exercise level (<7 h/wk) and willing to avoid exercise 24-h prior to blood and stool sampling and 12-h prior to bone measurements
willing to ingest a dietary BC supplement or placebo (up to 900 mg/day, two 450 mg capsules) as well as 400 mg calcium and 500 IU vitamin D daily
willing to avoid other dietary supplements for the duration of the study
willing to avoid intake of foods extremely rich in anthocyanins and fermented dairy products containing viable Bifidobacteria or Lactobacilli
willing to have 3 blood draws, 2 stool collections, and 2 bone scans
willing to take urine pregnancy test if they are perimenopausal

Exclusion Criteria

those with metabolic bone disease, renal disease, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases
those with hypertension or on drugs that lower blood pressure
those with planned surgery during the study period or within 2 weeks of ending the intervention
taking medications that alter bleeding (such as antiplatelets or anticoagulants) or those with a bleeding disorder
taking a phenothiazine drug (most commonly used for nausea or mental health conditions)
having a sensitivity or allergy to any of ingredients for the placebo (rice powder) and calcium/D supplement (calcium citrate, polyethylene glycol, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, oligofructose enriched inulin, propylene glycol dicaprylate/dicaprate, talc, titanium dioxide, vitamin D3)
heavy smokers (>20 cigarettes/day)
perimenopausal women with any chance or plan of pregnancy
taking prescription medications known to alter bone and Ca metabolism such as calcitonin, bisphosphonates, raloxifene within 3 months before the start of the study
taking anabolic agents such as parathyroid hormone, growth hormone, or steroids within 3 months before the start of the study
planning any procedure that includes iodine, barium or nuclear medicine isotopes in next 7 months
alcohol consumption exceeding 2 drinks/day (approximately 14 g ethanol per drink) or a total of 12/week
UConn students and/or employees who any key personnel teach or who report to any key personnel
study key personnel, spouses of key personnel, or dependents/relatives of any key personnel
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