Citruslabs
Las Vegas, Nevada, 89118, United States
NCT Number: NCT07354308
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.
This study is active but is not currently recruiting participants.
18 year–70 year
All sexes
Interventional
Not applicable
Las Vegas, Nevada, 89118, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will take 8 Intervention capsules per day (4 in the morning, 4 in the afternoon)
Participants will take 8 placebo capsules per day (4 in the morning, 4 in the afternoon)
Time frame: Baseline through Week 16
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.
Time frame: 2 weeks before Baseline and Weeks 14-16
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.
Time frame: Baseline and Week 16
Assessed via blood samples at Labcorp or via home phlebotomy.
Time frame: Baseline and Week 16
Assessed via blood samples at Labcorp or via home phlebotomy.
Time frame: Baseline and Week 16
Includes Cholesterol, LDL, VLDL, HDL, and triglycerides. Measured via Labcorp or home phlebotomy.
Time frame: Baseline and Week 16
High-sensitivity C-reactive protein measured via Labcorp or home phlebotomy.
Time frame: Baseline and Week 16
Only measured in the home phlebotomy subgroup using InterScience Institute lab testing.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Measured with a tape measure.
Time frame: 2 weeks before Baseline and Weeks 14-16
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.
Time frame: 2 weeks before Baseline and Weeks 14-16
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.
Time frame: 2 weeks before Baseline and Weeks 14-16
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.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Evaluated using the Short Form-12 (SF-12) questionnaire.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Evaluated using the Godin Leisure-Time Exercise Questionnaire (GLTE).
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Evaluated using the Three-Factor Eating Questionnaire - Revised 21 (TFEQ-R21).
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Evaluated using the Food Craving Questionnaire - Trait reduced (FCQ-T reduced).
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Participants report changes in energy levels, weight perception, mood, and general well-being.
Time frame: Weekly from Baseline to Week 16
Total skeletal muscle mass measured in kilograms using a Withings smart scale via Bioelectrical Impedance Analysis (BIA).
Time frame: Weekly from Baseline to Week 16
Total weight of body fat measured in kilograms using a Withings smart scale via Bioelectrical Impedance Analysis (BIA).
Time frame: Weekly from Baseline to Week 16
Estimated weight of bone mineral content in kilograms, measured using a Withings smart scale via Bioelectrical Impedance Analysis (BIA).
Time frame: Weekly from Baseline to Week 16
Total fat-free mass (including muscle, bone, and water) measured in kilograms using a Withings smart scale via Bioelectrical Impedance Analysis (BIA).
Time frame: Weekly from Baseline to Week 16
Total body water as a percentage of total body weight, measured using a Withings smart scale via Bioelectrical Impedance Analysis (BIA).
Time frame: Weekly from Baseline to Week 16
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.
SP Nutraceuticals Inc.
Industry
A Study to Evaluate the Efficacy of an Avocado Dietary Supplement to Support Healthy Weight and Blood Glucose Management
Acronym: METAVO-ONE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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