Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk

What this trial studies

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

Conditions in scope

• Postmenopausal Osteoporosis
• Gut Microbiota
• Cardiovascular Diseases

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

Who can join

Women only · Ages 45 Years to 60 Years · Accepts 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE1
• Start date: 2021-07-20
• Primary completion: 2022-10-03
• Last update posted: 2025-08-12
• First posted: 2020-06-16

Sponsor & contact

Lead sponsor: University of Connecticut (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Bone Mineral Density (BMD) (From baseline to 6 months)
  Changes in BMD of whole-body measured via dual energy x-ray absorptiometry

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.