Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk

NCT04431960 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: HR20-00352020-67018-30852
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postmenopausal Osteoporosis; Gut Microbiota; Cardiovascular Diseases

Keywords

blackcurrant; gut microbiome; osteoporosis; menopause; bone aging; women; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density (BMD)

  Changes in BMD of whole-body measured via dual energy x-ray absorptiometry

  From baseline to 6 months

Secondary Outcomes (3)

• Serum Marker of Bone Formation

  From baseline to 6 months

• Plasma Regulator of Bone Metabolism

  From baseline to 6 months

• Changes in Plasma Inflammatory Cytokine

  From baseline to 6 months

Other Outcomes (6)

• Changes in Gut Microbial Composition

  from baseline to 6 months

• Serum Inflammation Biomarker

  from baseline to 6 months

• Fasting Blood Lipids

  from baseline to 6 months

Study Arms (3)

low-BC Group

ACTIVE COMPARATOR

consume: 1) one tablet containing 392 mg blackcurrant (BC) extract per capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D

Drug: blackcurrant (BC) extract

high-BC Group

ACTIVE COMPARATOR

consume: 1) two capsules containing 392 mg BC extract per tablet (total 784 mg/day) and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D

Drug: blackcurrant (BC) extract

Control Group

PLACEBO COMPARATOR

consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D

Drug: blackcurrant (BC) extract

Interventions

blackcurrant (BC) extract DRUG

A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency

Also known as: BPE75 (392 mg and 784 mg)

Control Group; high-BC Group; low-BC Group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: perimenopausal or early postmenopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut Department of Nutritional Sciences and Kinesiology Human Performance Laboratory

Storrs, Connecticut, 06269, United States

Location

Related Publications (1)

• Nosal BM, Thornton SN, Darooghegi Mofrad M, Sakaki JR, Mahoney KJ, Macdonald Z, Daddi L, Tran TDB, Weinstock G, Zhou Y, Lee EC, Chun OK. Blackcurrants shape gut microbiota profile and reduce risk of postmenopausal osteoporosis via the gut-bone axis: Evidence from a pilot randomized controlled trial. J Nutr Biochem. 2024 Nov;133:109701. doi: 10.1016/j.jnutbio.2024.109701. Epub 2024 Jul 15.

  PMID: 39019119 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Cardiovascular Diseases; Osteoporosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ock K. Chun
• Organization: University of Connecticut

ock.chun@uconn.edu

18604866275

Study Officials

• Ock K Chun, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The extract and placebo will have the identical shape and color and will be packaged into coded containers.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study participants will be randomly assigned to three groups and asked to consume 1 tablet containing 392 mg blackcurrant (BC) extract per capsule (low-BC Group), 2 capsules containing 392 mg BC extract per tablet (total 784 mg/day; high-BC Group), or 1 placebo capsule (Control Group) daily with breakfast meals for 6 months. To avoid bone deterioration related to calcium and vitamin D deficiency, all participants will take a calcium citrate caplet daily that includes 400 mg calcium and 500 IU vitamin D (Bayer AG, Germany) beginning 2 weeks before the study and lasting for the duration of the study.

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 16, 2020
• Study Start: July 20, 2021
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: August 12, 2025
• Results First Posted: October 21, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Unlimited time after papers are published.
• Access Criteria: Our plan of sharing of data generated by this project includes the following: 1. Presentations at national scientific meetings. From the projects, 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 the experiment data. Data used in publications will be released in a timely manner.

Locations

US (1)