Obesity &Amp; Overweight
Conditions
Keywords
Obesity, Immunity, Microbiome, Gut, Grape, Stress
Brief summary
This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.
Detailed description
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.
Interventions
48 g/day oral consumption during the 4-week active period.
OTHERPlacebo powder
Isocaloric placebo matched to grape powder; oral consumption during the 4-week active period.
Sponsors
University of Missouri-Columbia
California Table Grape Commission
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Weight stable (\<5kg change over last 3 months) * Non-smoker \> 1 year or more * Not currently consuming an extremely healthy diet
Exclusion criteria
* Study food allergies * Regular consumption of grapes or grape-derived products * Gastrointestinal disease and/or bariatric surgery * Uncontrolled hypertension and blood pressure \>180/110 * Diabetes * Illicit drug use * History of alcohol or drug abuse * Recent use of medications that affect immune function (e.g., corticosteroids) * Recent consumption of antibiotics, prebiotics, probiotics, symbiotics, or dietary supplements containing fiber or phytochemicals * Pregnant or lactating individuals * HIV positivity * Recent start of medications that affect metabolism or appetite * Drug therapy for coronary artery disease, peripheral artery disease, congestive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbial diversity | Baseline, Week 4, Week 8, Week 12 | Assessed via 16s rRNA sequencing |
| LPS-binding protein concentration | Baseline, Week 4, Week 8, Week 12 | Intestinal permeability marker |
| Cytokine concentrations following PBMC stimulation | Baseline, Week 4, Week 12 | IL-6, IL-10 |
| Perceived stress score | Baseline, Week 4, Week 8, Week 12 | Assessed using validated Cohen's Perceived Stress Scale. Scores range from 0-56 with higher scores indicating greater stress perceptions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome abundance | Baseline, Week 4, Week 8, Week 12 | Assessed via 16s rRNA sequencing |
| Inflammatory Markers | Baseline, Week 4, Week 8, Week 12 | IL-6, IL-10, TNF-alpha, IFN-gamma |
| Body mass | Baseline, Week 4, Week 8, Week 12 | Measured in kg |
| Body composition | Baseline, Week 4, Week 8, Week 12 | Fat mass and fat-free mass |
| Anthropometrics | Baseline, Week 4, Week 8, Week 12 | Waist circumference, hip circumference, thigh circumference |
| Glucoregulation | Baseline, Week 4, Week 8, Week 12 | Fasting glucose concentrations |
| Insulinemic biomarker concentrations | Baseline, Week 4, Week 8, Week 12 | Insulin concentrations |
| Lipid profile | Baseline, Week 4, Week 8, Week 12 | LDL, HDL, triglycerides, total cholesterol |
| Blood pressure | Baseline, Week 4, Week 8, Week 12 | Diastolic and systolic blood pressure |
| Dietary intake using 24-hour recalls | Every week | 24-hour diet recall using Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24). |
| Physical activity | Baseline, Week 4, Week 8, Week 12 | Activity assessment using Actigraphs |
| Sleep indices from Actigraphs | Baseline, Week 4, Week 8, Week 12 | Assessed using Actigraphs |
| 24-hour appetite ratings | Baseline, Week 4, Week 8, Week 12 | 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." |
| Palatability rating of foods | Every week | Hedonic general labelled magnitude scale (gLMS). Scores range from 0 to 100. |
| Acceptance rating of foods | Every week | 9-point food action rating scale (1-9) with higher scores indicating a higher food rating. |
| Dietary Intake over past month | Baseline, Week 4, Week 8, Week 12 | Assessed using Food Frequency Questionnaires |
| IPAQ Score | Baseline, Week 4, Week 8, Week 12 | Measured using the International Physical Activity Questionnaire (IPAQ). Activity levels categorized as high, moderate, or low based on IPAQ scoring procedure. |
| Sleep indices from sleep diary | Baseline, Week 4, Week 8, Week 12 | Assessed using sleep diary |
Countries
United States
Contacts
CONTACTJaapna Dhillon PhD, PhD
CONTACTCaitlyn Winn, MS
Outcome results
None listed