Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis Risk in Postmenopausal Females
Recruiting · NCT07365514 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Connecticut
View the official record on ClinicalTrials.gov →Interventions studied
Blackcurrant (BC) extractPlacebo
What this trial is about
The goal of this clinical trial is to evaluate the effects of blackcurrant (BC) supplementation on changes in bone density and gut microbiome composition in postmenopausal females.
Who can take part
Age range
45 Years to 70 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- postmenopausal (defined as no more than 10 years since final menstrual cycle) females aged 45-70 years
- not on hormone replacement therapy for at least one year before initiation of the study
- maintaining normal exercise level (\< 7 hours/week) and willing to avoid exercise for 24 hours prior to blood and stool sampling
- willing to ingest a dietary blackcurrant supplement or placebo (up to 1,176 mg/day, three 392mg capsules)
- 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 three blood draws, three stool collections, and three bone scans
Exclusion criteria
- history of cardiovascular disease, osteoporosis, metabolic bone disease, cancer, diabetes mellitus, arthritis, or other chronic inflammatory diseases
- current smokers
- taking prescription medications known to alter bone and calcium metabolism
- taking anabolic agents such as parathyroid hormone or growth hormone, or steroid within 3 months before the start of the study
- taking medications that alter bleeding (such as antiplatelets or anticoagulants) or those with a bleeding disorder
- alcohol consumption exceeding 2 drinks/day (approximately 14g of ethanol per drink) or a total of 12/week
- those with planned surgery during the study period or within 2 weeks of ending the intervention
- those with sensitivities or allergies to any of the ingredients for the placebo (rice powder)
- planning a procedure that includes iodine, barium or nuclear medicine isotopes within the study period
- UConn students and/or employees who any key personnel teach or who report to any key personnel
- study key personnel, partners of key personnel, or dependents/relatives of any key personnel
Where it is running
1 location listed across 1 US state.
- University of Connecticut, Department of Nutritional Sciences - Storrs, Connecticut, United States