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OpenTrials
Completed

NCT Number: NCT06333496

Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans

BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.

PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.

SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints.

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Key information

Conditions

Blood Sugar; High Body Weight Fat Burn Glucose Metabolism Disorders Heart Health Markers Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alpine Bio

Salt Lake City, Utah, 84109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteers must be over the age of 18.
  • Volunteers cannot be smokers.
  • Volunteers cannot be currently taking a dietary supplement or prescription for weight loss.
  • Exercising volunteers must maintain their regimen consistently throughout the course of the 12-week study.
  • Caffeine drinking volunteers must maintain their caffeine intake consistently throughout the course of the 12-week study.
  • Volunteers need to be overweight but not obese, as defined by having a BMI between 25.0 and 29.9

Exclusion criteria

  • Female volunteers who are pregnant or planning to become pregnant within the next three months.
  • Volunteers who are taking any stimulant medications (e.g. Adderall, Adzenys, Dexedrine, Ritalin, Methylphenidate, etc).

Treatment and study plan

GLP-1 Booster (GB)

Dietary Supplement

GLP-1 Booster (GB) is a composition designed to increase the endogenous production of GLP-1, improve the activity of GLP-1, enhance the body's response to GLP-1, and thus eventually help people reduce glucose, suppress food intake and lose body fat. GB contains Green tea (Camellia sinensis) leaf extract, Gardeniae (Gardenia jasminoides Ellis) fructus extract, Turmeric (Curcuma longa) root extract, Black pepper (Piper nigrum) extract,Fenugreek (Trigonella foenum-graecum) seed extract, Ginseng (Panax ginseng) root extract, and White kidney bean (Phaseolus vulgaris) extract. Each of these ingredients has been commonly consumed by humans as food sources or supplements and thus has an undebatable safety profile.

Primary outcomes

  1. blood glucose level

    Time frame: 12 week

  2. blood HbA1c level

    Time frame: 12 week

  3. blood insulin level

    Time frame: 12 week

  4. blood GLP1 level

    Time frame: 12 week

  5. blood cholesterol level

    Time frame: 12 week

  6. body weight

    Time frame: 12 week

  7. body fat mass

    Time frame: 12 week

  8. body lean mass

    Time frame: 12 week

  9. body mass index

    Time frame: 12 week

  10. body fat index

    Time frame: 12 week

  11. waist hip ratio

    Time frame: 12 week

Secondary outcomes

  1. Satiety score

    Time frame: 12 week

  2. Resting metabolic rate

    Time frame: 12 week

  3. Blood pressure

    Time frame: 12 week

    both systolic and diastolic pressures

  4. Heart rate

    Time frame: 12 week

Sponsors and collaborators

Lead sponsor

Alpine Biotech LLC

Industry

Registry information

Official study title

Effect of a Glucagon Like Peptide 1 (GLP1) Booster on Blood Glucose, HbA1c, Insulin, and GLP1 Levels, Body Weight and Body Fat in Overweight Adult Men and Women

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Dec 5, 2024

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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