- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354308
Study to Evaluate the Efficacy of an Avocado Dietary Supplement (METAVO-ONE)
January 14, 2026 updated by: SP Nutraceuticals Inc.
A Study to Evaluate the Efficacy of an Avocado Dietary Supplement to Support Healthy Weight and Blood Glucose Management
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89118
- Citruslabs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be male or female
- Be aged between 18 and 70 years of age
- Be classified as overweight or obese with a BMI of ≥25.0 and ≤32 kg/m2.
- Have a stable weight defined as <10% change in body weight in three months prior to the study start date.
- Willing to follow the provided diet and exercise guidelines.
- Willing to not consume avocados throughout the trial and for two weeks prior to Baseline
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- Willing to stop any products, any prescription medication, or supplements that target weight management, blood sugar control, and/or aim to improve insulin during the test period.
- Willing to avoid introducing any new products or any new forms of prescription medication or supplements that target weight management, blood sugar control, and/or aim to improve insulin during the test period.
- Not currently partaking in another research study and will not be partaking in any other research study for the next 16 weeks and at any point during this study's duration.
- Must have someone available to take front and side profiles of the torso.
- Must have a smart phone or camera capable of taking photos of the torso.
- Resides in the United States.
Exclusion Criteria:
- Anyone with diagnosed Type I or Type II diabetes.
- Allergic to avocados
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive
- Anyone unwilling to follow the study protocol.
- Has stopped using hormonal birth control in the past month.
- Anyone with a history of substance abuse.
- Anyone who is currently a smoker or has been a smoker in the past 6 months.
- Anyone with chronic health conditions that could impact participation in the study, such as oncological, psychiatric, metabolic, hypertension, or cardiovascular disorders, cancer, autoimmune disease, HIV, Hepatitis B, and/or C, kidney and/or liver, gastrointestinal, gastroesophageal reflux, blood/bleeding disorders, gout, or mental health disorders.
- Anyone who has had any major illness in the last 3 months.
- Anyone who drinks heavily (i.e., 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- Current use of prescribed medications as listed below: Weight loss prescription medication (within 3 months of baseline). Anticoagulants and coagulants (within 4 weeks of baseline).
- Anyone who has used any cannabis products (medical or recreational) in the past month.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Metavo Supplement Group
Participants in this group will receive the Metavo dietary supplement for 16 weeks.
|
Participants will take 8 Intervention capsules per day (4 in the morning, 4 in the afternoon)
|
|
Placebo Comparator: Placebo Group
Participants in this group will receive placebo capsules that are visually matched to the Metavo supplement for 16 weeks.
|
Participants will take 8 placebo capsules per day (4 in the morning, 4 in the afternoon)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Mass
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.
|
Baseline through Week 16
|
|
Change in Average Blood Glucose
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.
|
2 weeks before Baseline and Weeks 14-16
|
|
Change in Hemoglobin A1C (HbA1C)
Time Frame: Baseline and Week 16
|
Assessed via blood samples at Labcorp or via home phlebotomy.
|
Baseline and Week 16
|
|
Change in Fasting Insulin
Time Frame: Baseline and Week 16
|
Assessed via blood samples at Labcorp or via home phlebotomy.
|
Baseline and Week 16
|
|
Change in Lipid Panel
Time Frame: Baseline and Week 16
|
Includes Cholesterol, LDL, VLDL, HDL, and triglycerides.
Measured via Labcorp or home phlebotomy.
|
Baseline and Week 16
|
|
Change in hs-CRP
Time Frame: Baseline and Week 16
|
High-sensitivity C-reactive protein measured via Labcorp or home phlebotomy.
|
Baseline and Week 16
|
|
Change in Fasting GLP-1 Levels
Time Frame: Baseline and Week 16
|
Only measured in the home phlebotomy subgroup using InterScience Institute lab testing.
|
Baseline and Week 16
|
|
Change in Waist Circumference
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
|
Measured with a tape measure.
|
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
|
|
Change in Time in Range (TIR)
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.
|
2 weeks before Baseline and Weeks 14-16
|
|
Change in Time Below Range (TBR)
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.
|
2 weeks before Baseline and Weeks 14-16
|
|
Change in Time Above Range (TAR)
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.
|
2 weeks before Baseline and Weeks 14-16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
|
Evaluated using the Short Form-12 (SF-12) questionnaire.
|
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
|
|
Change in Physical Activity
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
|
Evaluated using the Godin Leisure-Time Exercise Questionnaire (GLTE).
|
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
|
|
Change in Eating Habits
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
|
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
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
|
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
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.
|
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
|
|
Change in Total Muscle Mass (kg)
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).
|
Weekly from Baseline to Week 16
|
|
Change in Total Body Fat Mass (kg)
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).
|
Weekly from Baseline to Week 16
|
|
Change in Bone Mass (kg)
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).
|
Weekly from Baseline to Week 16
|
|
Change in Total Lean Mass (kg)
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).
|
Weekly from Baseline to Week 16
|
|
Change in Total Body Water Percentage (%)
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).
|
Weekly from Baseline to Week 16
|
|
Change in Visceral Fat Index
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.
|
Weekly from Baseline to Week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
December 6, 2025
First Submitted That Met QC Criteria
January 14, 2026
First Posted (Actual)
January 21, 2026
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 14, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20710
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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