This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.
The study is a 12-wk randomized, controlled, crossover trial. Participants will be randomized to one of two intervention sequences, either consuming 48g/day of whole freeze-dried grape powder followed by an isocaloric placebo powder or consuming the placebo powder followed by the whole freeze-dried grape powder. Active intervention phases will be 4 weeks in duration followed by a 4-week washout period between treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
48 g/day oral consumption during the 4-week active period.
Isocaloric placebo matched to grape powder; oral consumption during the 4-week active period.
University of Missouri-Columbia
Columbia, Missouri, United States
RECRUITINGGut microbial diversity
Assessed via 16s rRNA sequencing
Time frame: Baseline, Week 4, Week 8, Week 12
LPS-binding protein concentration
Intestinal permeability marker
Time frame: Baseline, Week 4, Week 8, Week 12
Cytokine concentrations following PBMC stimulation
IL-6, IL-10
Time frame: Baseline, Week 4, Week 12
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 12
Gut microbiome abundance
Assessed via 16s rRNA sequencing
Time frame: Baseline, Week 4, Week 8, Week 12
Inflammatory Markers
IL-6, IL-10, TNF-alpha, IFN-gamma
Time frame: Baseline, Week 4, Week 8, Week 12
Body mass
Measured in kg
Time frame: Baseline, Week 4, Week 8, Week 12
Body composition
Fat mass and fat-free mass
Time frame: Baseline, Week 4, Week 8, Week 12
Anthropometrics
Waist circumference, hip circumference, thigh circumference
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Time frame: Baseline, Week 4, Week 8, Week 12
Glucoregulation
Fasting glucose concentrations
Time frame: Baseline, Week 4, Week 8, Week 12
Insulinemic biomarker concentrations
Insulin concentrations
Time frame: Baseline, Week 4, Week 8, Week 12
Lipid profile
LDL, HDL, triglycerides, total cholesterol
Time frame: Baseline, Week 4, Week 8, Week 12
Blood pressure
Diastolic and systolic blood pressure
Time frame: Baseline, Week 4, Week 8, Week 12
Dietary intake using 24-hour recalls
24-hour diet recall using Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24).
Time frame: Every week
Physical activity
Activity assessment using Actigraphs
Time frame: Baseline, Week 4, Week 8, Week 12
Sleep indices from Actigraphs
Assessed using Actigraphs
Time frame: Baseline, Week 4, Week 8, Week 12
24-hour appetite ratings
24-hour appetite ratings assessed using Visual Analog Scale. For each question scores range from 0-100 with higher scores indicating "extremely" and lower scores indicating "not at all."
Time frame: Baseline, Week 4, Week 8, Week 12
Palatability rating of foods
Hedonic general labelled magnitude scale (gLMS). Scores range from 0 to 100.
Time frame: Every week
Acceptance rating of foods
9-point food action rating scale (1-9) with higher scores indicating a higher food rating.
Time frame: Every week
Dietary Intake over past month
Assessed using Food Frequency Questionnaires
Time frame: Baseline, Week 4, Week 8, Week 12
IPAQ Score
Measured using the International Physical Activity Questionnaire (IPAQ). Activity levels categorized as high, moderate, or low based on IPAQ scoring procedure.
Time frame: Baseline, Week 4, Week 8, Week 12
Sleep indices from sleep diary
Assessed using sleep diary
Time frame: Baseline, Week 4, Week 8, Week 12