Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis Risk in Postmenopausal Females
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age45-70
SponsorUniversity of Connecticut
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Blackcurrant (BC) extract
DrugConsume three capsules per day containing 784 mg of blackcurrant (BC) extract (261.33 mg BC and 130.67 mg placebo per capsule)
Blackcurrant (BC) extract
DrugConsume three capsules containing 1,176 mg BC of extract (392 mg BC per capsule)
Placebo
DrugConsume three placebo capsules (392 mg placebo per capsule)
Treatment groups
159 Participants
are divided into 3 treatment groupsGroup A: Low-BC GroupActive comparator 1 intervention
Group B: High-BC GroupActive comparator 1 intervention
Group C: Control GroupPlacebo comparator 1 intervention
Trial outcomes
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)
Time frame
From baseline to months 6 and 12Secondary outcomes
1
Serum markers of bone remodeling
Changes in serum concentrations of bone remodeling markers including procollagen type I N-propeptide (P1NP), bone alkaline phosphatase (BALP), receptor activator of nuclear factor kappa-Β ligand (RANKL), and collagen Type I C-Telopeptide (CTX1)
Time frame
From baseline to months 6 and 12Other outcomes
1
Changes in community structure of gut microbiota
Changes in gut microbial composition will be assessed using alpha diversity (species richness and Shannon diversity) and beta diversity metrics, including Bray-Curtis dissimilarity (community abundance) and Jaccard distance (presence/absence). Taxonomic composition will be compared between groups by evaluating relative abundance at the genus and phylum levels.
Time frame
from baseline to months 6 and 122
Plasma inflammatory-immune markers
Inflammatory biomarkers will be assessed in plasma, including IL-1beta and TNF-alpha. Additional immune response markers related to T helper cell subtypes (Th1, Th2, Th17) will be measured in plasma (e.g., interleukin (IL)-2, IL-4, IL-6, IL-10, TNF, IL-17A). CD4+ Th17 and regulatory T cell (Treg) responses will also be evaluated from peripheral blood mononuclear cells (PBMCs).
Time frame
from baseline to months 6 and 123
Plasma endocrine markers
Changes in plasma concentrations of endocrine markers including insulin-like growth factor-1 (IGF-1) and cyclic glycine-proline (cGP)
Time frame
from baseline to months 6 and 124
Omics outcomes
Metabolomics, proteomics, and genotyping will be performed to identify biomarkers associated with blackcurrant supplementation and bone-related outcomes.
Time frame
from baseline to months 6 and 12Sponsors and contacts
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Source ClinicalTrials.gov