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Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk

Primary Purpose

Postmenopausal Osteoporosis, Gut Microbiota, Cardiovascular Diseases

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

blackcurrant (BC) extract

About this trial

This is an interventional prevention trial for Postmenopausal Osteoporosis focused on measuring blackcurrant, gut microbiome, osteoporosis, menopause, bone aging, women, cardiovascular disease

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

low-BC Group

high-BC Group

Control Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Bone mineral density (BMD)

changes in BMD of whole-body, head, arms, legs, trunk, ribs, spine, pelvis

Secondary Outcome Measures

Gut microbiota profile

changes in the gut microbial composition

Full Information

NCT ID

NCT04431960

First Posted

June 6, 2020

Last Updated

December 1, 2022

Sponsor

University of Connecticut

1. Study Identification

Unique Protocol Identification Number

NCT04431960

Brief Title

Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk

Official Title

Blackcurrant Modifies Gut Microbiota and Reduces the Risk of Postmenopausal Osteoporosis and Cardiovascular Disease: A Pilot Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

July 20, 2021 (Actual)

Primary Completion Date

October 3, 2022 (Actual)

Study Completion Date

October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Connecticut

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 distinct patterns of a decrease in estrogen, a natural antioxidant, simultaneously with adverse alterations in body fat distribution, lipids and lipoproteins, and measures of vascular health, which can increase a woman's risk of developing CVD. Overall goal of this project is to evaluate the effects of blackcurrant (BC) supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women. For this purpose, the investigators will conduct a pilot randomized placebo-controlled clinical trial with BC supplementation for 6 months in peri- and early postmenopausal women aged 45-60 years. The primary endpoint will be whole-body bone mineral density (BMD); secondary endpoints will be gut microbiota composition. To delineate the underlying mechanisms of the action, changes in biomarkers for bone metabolism, bone-related immune and endocrine systemic biomarkers, and CVD risk factors by BC supplementation will be measured in plasma and peripheral blood derived mononuclear cells. The specific objectives of the study are to investigate the effects of BC extract on: 1) bone mass and bone remodeling markers; 2) changes in the gut microbiota abundance and composition, immune and endocrine biomarkers, and CVD risk factors and their relationships with changes in bone mass. The proposed study will provide novel insight into whether and how BC consumption reduces the risk of postmenopausal bone loss and CVD in adult women and will improve understanding of the clinical roles of gut microbiome in postmenopausal bone loss. Findings from this study will help increase awareness of the bone and heart health promoting effect of BC and motivate increased production of BC and other berry products in response to the increasing consumer demand.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal Osteoporosis, Gut Microbiota, Cardiovascular Diseases

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The extract and placebo will have the identical shape and color and will be packaged into coded containers.

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

low-BC Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

high-BC Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

blackcurrant (BC) extract

Other Intervention Name(s)

BPE75 (392 mg and 784 mg)

Intervention Description

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

Primary Outcome Measure Information:

Title

Bone mineral density (BMD)

Description

changes in BMD of whole-body, head, arms, legs, trunk, ribs, spine, pelvis

Time Frame

from baseline to 6 months

Secondary Outcome Measure Information:

Title

Gut microbiota profile

Description

changes in the gut microbial composition

Time Frame

from baseline to 6 months

Other Pre-specified Outcome Measures:

Title

Serum bone metabolism biomarkers

Description

changes in serum concentrations of bone metabolism (BALP, P1NP, CTX-1, OC)

Time Frame

from baseline to 6 months

Title

Serum inflammation biomarker

Description

changes in serum inflammation biomarker (hs-CRP)

Time Frame

from baseline to 6 months

Title

Plasma CVD risk factors (lipids, oxidative stress, endothelial function)

Description

changes in plasma CVD risk factors

Time Frame

from baseline to 6 months

Title

Blood pressure (SBP/DBP), BMI, WC, body composition

Description

changes in blood pressure (SBP/DBP), BMI, WC, body composition

Time Frame

from baseline to 6 months

Title

Concentrations of plasma IL-1β, IL-6, TNFα, Th17 and Treg

Description

changes in plasma concentrations of immune biomarkers

Time Frame

from baseline to 6 months

Title

Concentrations of plasma IGF-1 and cGP

Description

changes in plasma concentrations of endocrine biomarkers

Time Frame

from baseline to 6 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

perimenopausal or early postmenopausal women

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ock K Chun, PhD

Organizational Affiliation

University of Connecticut

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Storrs

State/Province

Connecticut

ZIP/Postal Code

06269

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Once research proceedings and manuscripts are published we will make our results available both to the community of scientists interested in postmenopausal osteoporosis and to those studying the biology of inflammation-induced bone resorption to avoid unintentional duplication of research.

IPD Sharing Time Frame

Unlimited time after papers are published.

IPD Sharing Access Criteria

Our plan of sharing of data generated by this project includes the following: Presentations at national scientific meetings. From the projects, it is expected that approximately two presentations at national meetings would be appropriate. 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.

Learn more about this trial

Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk

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