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Study to Evaluate the Efficacy of an Avocado Dietary Supplement (METAVO-ONE)

S

SP Nutraceuticals

Status

Active, not recruiting

Conditions

Overweight
Insulin Resistance
Metabolic Health

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Metavo Supplement

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Metavo Supplement Group
Experimental group
Description:
Participants in this group will receive the Metavo dietary supplement for 16 weeks.
Treatment:
Dietary Supplement: Metavo Supplement
Placebo Group
Placebo Comparator group
Description:
Participants in this group will receive placebo capsules that are visually matched to the Metavo supplement for 16 weeks.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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