Grape Impact on Human Gut Microbiome
ConditionGut Microbiomes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This is a bio-specimen analysis and dietary intervention study that will examine whether the daily consumption of California table grape powder significantly modulates the gut microbiome and systemic immune profiles in healthy adults. The primary objective is to characterize longitudinal changes in microbial strains, metabolites, and immune markers following a 4-week grape intervention compared to a placebo. Methods include a screening of up to 300 individuals to evaluate pre-specified microbiome eligibility criteria, followed by a randomized, double-blind, placebo-controlled, parallel-group design where up to 40 participants will provide fecal and blood samples for high-resolution metagenomic sequencing and LC-MS/MS metabolomics at baseline, mid-study, and post-washout. Participants who meet the microbiome screening and other study eligibility criteria may be invited to participate in the intervention phase; participation in the screening phase does not guarantee enrollment in the intervention phase.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults between the ages of 45 and 65 years old
Body Mass Index (BMI) within the range of 18.5 to 25.9 kg/m²
Willing and able to provide informed consent
Agreement to maintain usual dietary patterns throughout the study, except for the provided study powder
Disqualifiers
Able and willing to collect and mail a stool sample during the microbiome screening phase and, if enrolled in the intervention phase, and at the three defined study timepoints
For enrollment into the intervention phase, meeting pre-specified microbiome eligibility criteria based on the screening stool sample, as defined in the study protocol.
Antibiotic use within 6 months prior to enrollment, or any planned antibiotic use during the study
Recent initiation of or dose change in any medication or supplement within 3 months prior to enrollment, or planned initiation or dose change during the study
Trial design
Design model
Parallel
Treatments tested in this trial
Grape Powder
Dietary supplement72 g of grape powder for daily consumption for 28 days.
Placebo Powder
Other intervention72 g of matching placebo for daily consumption for 28 days.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Grape PowderExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Long read sequencing
Sequencing DNA from fecal samples to identify bacteria. This will assess whether the grape powder induces a change in the abundance of beneficial species/decrease in harmful species, following treatment, compared to control. This will be quantitatively assessed via sequencing.
Time frame
3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)Secondary outcomes
1
Fecal metabolites profile from LC-MS/MS
Fecal metabolites as measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
Time frame
3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)2
Fecal calprotectin level measured by ELISA
Fecal calprotectin as measured by ELISA. Elevated levels of calprotectin are a sensitive indicator of mucosal irritation.
Time frame
3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)3
Fecal albumin level measured by ELISA
Fecal albumin as measured by ELISA. Fecal albumin serves as a proxy for intestinal permeability, as its presence in the gut lumen suggests a leak across the epithelial barrier.
Time frame
3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)4
Fecal Lipocalin-2 measured by ELISA
Fecal Lipocalin-2 as measured by ELISA. Fecal Lipocalin-2 is produced by both epithelial and immune cells in response to bacterial stressors.
Time frame
3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: