Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis Risk in Postmenopausal Females

NCT07365514 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: B2025-03802025-67018-45103
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density (BMD)

  Changes from baseline in whole-body, lumbar spine, total hip and femoral neck BMD at months 6 and 12 measured via dual energy x-ray absorptiometry (DXA)

  From baseline to months 6 and 12

Secondary Outcomes (1)

• Serum markers of bone remodeling

  From baseline to months 6 and 12

Other Outcomes (4)

• Changes in community structure of gut microbiota

  from baseline to months 6 and 12

• Plasma inflammatory-immune markers

  from baseline to months 6 and 12

• Plasma endocrine markers

  from baseline to months 6 and 12

Study Arms (3)

Low-BC Group

ACTIVE COMPARATOR

Low-dose BC extract

Drug: Blackcurrant (BC) extract

High-BC Group

ACTIVE COMPARATOR

High-dose BC extract

Drug: Blackcurrant (BC) extract

Control Group

PLACEBO COMPARATOR

Placebo (no BC extract)

Drug: Placebo

Interventions

Blackcurrant (BC) extract DRUG

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

Low-BC Group

Placebo DRUG

Consume three placebo capsules (392 mg placebo per capsule)

Control Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Gender Eligibility Details: Postmenopausal females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut, Department of Nutritional Sciences

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ock Chun, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ock Chun, PhD

CONTACT

860-486-6275; ock.chun@uconn.edu

Briana Nosal, MS

CONTACT

860-878-0679; briana.nosal@uconn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Study participants will be randomly assigned to one of three groups and asked to consume three capsules per day in the morning for 12 months as follows: 1) 3 capsules containing 784 mg blackcurrant (BC) extract (261.33 mg BC and 130.67 mg placebo per capsule; low BC group); or 2) 3 capsules containing 1,176 mg BC extract (three 392 mg BC capsules; high BC group); or 3) 3 placebo capsules (392 mg placebo per capsule; control group).

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Unlimited time after papers are published.
• Access Criteria: Our plan for sharing of data generated by this project includes the following: 1. Presentations at national scientific meeting. From the project, it is expected that approximately two presentations at national meetings would be appropriate. 2. Publication in peer-reviewed journals. It is our explicit intention that the study findings and key data will be placed in a readily accessible public database. All efforts will be made to rapidly release data through publication of results as quickly as possible following our analysis of experiment data. Data used in publications will be released in a timely manner.

Locations

US (1)