Recruiting
Phase 1

Blackcurrant

Sponsor:

University of Connecticut

Code:

NCT07365514

Conditions

Postmenopausal Osteoporosis

Gut Microbiome

Menopause

Eligibility Criteria

Sex: Female

Age: 45 - 70

Healthy Volunteers: Accepted

Interventions

Blackcurrant (BC) extract

Blackcurrant (BC) extract

Placebo

Study Details

Brief summary:

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.

Conditions

Postmenopausal Osteoporosis

Gut Microbiome

Menopause

Study ID

NCT07365514

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

159 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Low-BC Group

Low-dose BC extract

active comparator: High-BC Group

High-dose BC extract

placebo comparator: Control Group

Placebo (no BC extract)

Interventions

Blackcurrant (BC) extract

Consume three capsules per day containing 784 mg of blackcurrant (BC) extract (261.33 mg BC and 130.67 mg placebo per capsule)

Blackcurrant (BC) extract

Consume three capsules containing 1,176 mg BC of extract (392 mg BC per capsule)

Placebo

Consume three placebo capsules (392 mg placebo per capsule)

Primary outcome measure

  • Bone Mineral Density (BMD) [ Time Frame: From baseline to months 6 and 12 ]

Central Contacts and Locations

Central contacts

Locations

University of Connecticut, Department of Nutritional Sciences

Recruiting

Storrs, Connecticut, United States, 06269

Contacts

More Information

Sponsor

University of Connecticut

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • blackcurrant
  • gut microbiome
  • osteoporosis
  • menopause
  • females
  • bone aging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by University of Connecticut on 2026-07-23.