Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk
Condition: Postmenopausal Osteoporosis; Gut Microbiota; Cardiovascular Diseases
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): blackcurrant (BC) extract
Intervention type(s): Drug
Intervention description(s): 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
Other intervention name(s): BPE75 (392 mg and 784 mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: blackcurrant; gut microbiome; osteoporosis; menopause; bone aging; women; cardiovascular disease