Effects of Grape Consumption on the Immune-Gut Axis in Obesity
ConditionObesity &Amp; Overweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Missouri-Columbia
About this trial
This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-60 years
Obesity with BMI of 30-45 kg/m2
Willingness to consume study foods
Consistent diet and activity patterns for 4 weeks
Disqualifiers
Study food allergies
Regular consumption of grapes or grape-derived products
Gastrointestinal disease and/or bariatric surgery
Uncontrolled hypertension and blood pressure >180/110
Trial design
Design model
Crossover
Treatments tested in this trial
Freeze-dried grape powder
Other intervention48 g/day oral consumption during the 4-week active period.
Placebo powder
Other interventionIsocaloric placebo matched to grape powder; oral consumption during the 4-week active period.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Sequence 1: Grape then PlaceboExperimental treatment 2 interventions
Group B: Sequence 2: Placebo then GrapeExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Gut microbial diversity
Assessed via 16s rRNA sequencing
Time frame
Baseline, Week 4, Week 8, Week 122
LPS-binding protein concentration
Intestinal permeability marker
Time frame
Baseline, Week 4, Week 8, Week 123
Cytokine concentrations following PBMC stimulation
IL-6, IL-10
Time frame
Baseline, Week 4, Week 124
Perceived stress score
Assessed using validated Cohen's Perceived Stress Scale. Scores range from 0-56 with higher scores indicating greater stress perceptions.
Time frame
Baseline, Week 4, Week 8, Week 12Secondary outcomes
1
Gut microbiome abundance
Assessed via 16s rRNA sequencing
Time frame
Baseline, Week 4, Week 8, Week 122
Inflammatory Markers
IL-6, IL-10, TNF-alpha, IFN-gamma
Time frame
Baseline, Week 4, Week 8, Week 123
Body mass
Measured in kg
Time frame
Baseline, Week 4, Week 8, Week 124
Body composition
Fat mass and fat-free mass
Time frame
Baseline, Week 4, Week 8, Week 12Other outcomes
1
Memory indices
Assessed using memory tests
Time frame
Baseline, Week 4, Week 8, Week 122
Attention indices
Assessed using d2 test of attention
Time frame
Baseline, Week 4, Week 8, Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Missouri-Columbia
Lead sponsor
California Table Grape Commission
Collaborator
Source ClinicalTrials.gov