Blackcurrant Modifies Gut Microbiota and Reduces Osteoporosis Risk

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Connecticut

Criteria

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.