Status:
COMPLETED
Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk
Lead Sponsor:
University of Connecticut
Conditions:
Postmenopausal Osteoporosis
Gut Microbiota
Eligibility:
FEMALE
45-60 years
Phase:
PHASE1
Brief Summary
Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women.
Detailed Description
Postmenopausal bone loss is a primary contributor to osteoporosis and osteoporotic fractures in adult women in menopause transition. By following women over this period, studies have documented distin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04431960
Start Date
July 20 2021
End Date
October 3 2022
Last Update
August 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Connecticut Department of Nutritional Sciences and Kinesiology Human Performance Laboratory
Storrs, Connecticut, United States, 06269