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| Name | Class |
|---|---|
| California Table Grape Commission | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Grape then Placebo | Experimental | Whole freeze-dried grape powder for 4 weeks, 4-week washout, then isocaloric placebo powder for 4 weeks. |
|
| Sequence 2: Placebo then Grape | Experimental | Isocaloric placebo powder for 4 weeks, 4-week washout, then whole freeze-dried grape powder for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried grape powder | Other | 48 g/day oral consumption during the 4-week active period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbial diversity | Assessed via 16s rRNA sequencing | Baseline, Week 4, Week 8, Week 12 |
| LPS-binding protein concentration | Intestinal permeability marker | Baseline, Week 4, Week 8, Week 12 |
| Cytokine concentrations following PBMC stimulation | IL-6, IL-10 | 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. | Baseline, Week 4, Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome abundance | Assessed via 16s rRNA sequencing | Baseline, Week 4, Week 8, Week 12 |
| Inflammatory Markers | IL-6, IL-10, TNF-alpha, IFN-gamma |
| Measure | Description | Time Frame |
|---|---|---|
| Memory indices | Assessed using memory tests | Baseline, Week 4, Week 8, Week 12 |
| Attention indices | Assessed using d2 test of attention | Baseline, Week 4, Week 8, Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaapna Dhillon PhD, PhD | Contact | 573-884-2103 | jdhillon@health.missouri.edu | |
| Caitlyn Winn, MS | Contact | 207-210-8049 | cawq6x@umsystem.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Recruiting | Columbia | Missouri | 65211 | United States |
Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
Immediately following publication. No end date.
Data will be deposited in online repositories
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo powder | Other | Isocaloric placebo matched to grape powder; oral consumption during the 4-week active period. |
|
| Baseline, Week 4, Week 8, Week 12 |
| Body mass | Measured in kg | Baseline, Week 4, Week 8, Week 12 |
| Body composition | Fat mass and fat-free mass | Baseline, Week 4, Week 8, Week 12 |
| Anthropometrics | Waist circumference, hip circumference, thigh circumference | Baseline, Week 4, Week 8, Week 12 |
| Glucoregulation | Fasting glucose concentrations | Baseline, Week 4, Week 8, Week 12 |
| Insulinemic biomarker concentrations | Insulin concentrations | Baseline, Week 4, Week 8, Week 12 |
| Lipid profile | LDL, HDL, triglycerides, total cholesterol | Baseline, Week 4, Week 8, Week 12 |
| Blood pressure | Diastolic and systolic blood pressure | 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). | Every week |
| Physical activity | Activity assessment using Actigraphs | Baseline, Week 4, Week 8, Week 12 |
| Sleep indices from Actigraphs | Assessed using Actigraphs | 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." | Baseline, Week 4, Week 8, Week 12 |
| Palatability rating of foods | Hedonic general labelled magnitude scale (gLMS). Scores range from 0 to 100. | Every week |
| Acceptance rating of foods | 9-point food action rating scale (1-9) with higher scores indicating a higher food rating. | Every week |
| Dietary Intake over past month | Assessed using Food Frequency Questionnaires | 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. | Baseline, Week 4, Week 8, Week 12 |
| Sleep indices from sleep diary | Assessed using sleep diary | Baseline, Week 4, Week 8, Week 12 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |