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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This 16-week, randomized, triple-blinded, placebo-controlled study evaluates the effects of an avocado dietary supplement (Metavo) on healthy weight and blood glucose management in overweight adults. The study includes body measurements, questionnaires, blood tests, and CGM monitoring to assess metabolic outcomes and participant-reported perceptions of well-being.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metavo Supplement Group | Experimental | Participants in this group will receive the Metavo dietary supplement for 16 weeks. |
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| Placebo Group | Placebo Comparator | Participants in this group will receive placebo capsules that are visually matched to the Metavo supplement for 16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metavo Supplement | Dietary Supplement | Participants will take 8 Intervention capsules per day (4 in the morning, 4 in the afternoon) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass | Measured via Withings Smart Scale. Participants will weigh themselves daily for 3 consecutive days each week. If the first two values are similar, their average is used. If they differ by ≥10 lbs, the third value is used to determine the average. | Baseline through Week 16 |
| Change in Average Blood Glucose | Change in average blood glucose levels measured using a Continuous Glucose Monitor (CGM). Average glucose will be calculated over each time period and the change from pre-baseline to Weeks 14-16 will be reported. | 2 weeks before Baseline and Weeks 14-16 |
| Change in Hemoglobin A1C (HbA1C) | Assessed via blood samples at Labcorp or via home phlebotomy. | Baseline and Week 16 |
| Change in Fasting Insulin | Assessed via blood samples at Labcorp or via home phlebotomy. | Baseline and Week 16 |
| Change in Lipid Panel | Includes Cholesterol, LDL, VLDL, HDL, and triglycerides. Measured via Labcorp or home phlebotomy. | Baseline and Week 16 |
| Change in hs-CRP | High-sensitivity C-reactive protein measured via Labcorp or home phlebotomy. | Baseline and Week 16 |
| Change in Fasting GLP-1 Levels | Only measured in the home phlebotomy subgroup using InterScience Institute lab testing. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Evaluated using the Short Form-12 (SF-12) questionnaire. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 |
| Change in Physical Activity | Evaluated using the Godin Leisure-Time Exercise Questionnaire (GLTE). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Las Vegas | Nevada | 89118 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Dietary Supplement | Participants will take 8 placebo capsules per day (4 in the morning, 4 in the afternoon) |
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| Baseline and Week 16 |
| Change in Waist Circumference | Measured with a tape measure. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 |
| Change in Time in Range (TIR) | Change in percentage of time that glucose levels are within the target range, measured using a CGM. TIR will be computed as the percentage of total CGM readings within the target range during the specified time periods. | 2 weeks before Baseline and Weeks 14-16 |
| Change in Time Below Range (TBR) | Change in percentage of time that glucose levels are below the target range, measured using a CGM. TBR will be calculated as the percentage of total CGM readings below the target range. | 2 weeks before Baseline and Weeks 14-16 |
| Change in Time Above Range (TAR) | Change in percentage of time that glucose levels are above the target range, measured using a CGM. TAR will be calculated as the percentage of total CGM readings above the target range. | 2 weeks before Baseline and Weeks 14-16 |
| Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 |
| Change in Eating Habits | Evaluated using the Three-Factor Eating Questionnaire - Revised 21 (TFEQ-R21). | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 |
| Change in Food Cravings | Evaluated using the Food Craving Questionnaire - Trait reduced (FCQ-T reduced). | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 |
| Change in Self-Reported Mood, Energy, and Health | Participants report changes in energy levels, weight perception, mood, and general well-being. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 |
| Change in Total Muscle Mass (kg) | Total skeletal muscle mass measured in kilograms using a Withings smart scale via Bioelectrical Impedance Analysis (BIA). | Weekly from Baseline to Week 16 |
| Change in Total Body Fat Mass (kg) | Total weight of body fat measured in kilograms using a Withings smart scale via Bioelectrical Impedance Analysis (BIA). | Weekly from Baseline to Week 16 |
| Change in Bone Mass (kg) | Estimated weight of bone mineral content in kilograms, measured using a Withings smart scale via Bioelectrical Impedance Analysis (BIA). | Weekly from Baseline to Week 16 |
| Change in Total Lean Mass (kg) | Total fat-free mass (including muscle, bone, and water) measured in kilograms using a Withings smart scale via Bioelectrical Impedance Analysis (BIA). | Weekly from Baseline to Week 16 |
| Change in Total Body Water Percentage (%) | Total body water as a percentage of total body weight, measured using a Withings smart scale via Bioelectrical Impedance Analysis (BIA). | Weekly from Baseline to Week 16 |
| Change in Visceral Fat Index | An indexed score representing the amount of visceral fat (the fat surrounding internal organs) measured via a Withings smart scale. This index typically ranges from 1 to 20, where higher scores indicate higher visceral fat levels. | Weekly from Baseline to Week 16 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |