Health TrialsbyHealthPanel

The Impact of a Daily Dietary Supplement on Glycemic Control in Individuals With Overweight or Obesity

ConditionsGlycemic ControlAppetite Regulation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of South Alabama

About this trial

This clinical trial will evaluate the efficacy of Metabolic Master Pack over a 90-day intervention period. Sixty adults will be randomized to receive either Metabolic Master Pack or placebo. Participants will wear continuous glucose monitors throughout the study, complete repeated blood collections, undergo DEXA body composition assessments, and complete dietary records. Results will provide high-quality evidence regarding the product's effects on glucose regulation and metabolic health.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI 25-40 kg/m²

Ability to provide informed consent

Disqualifiers

Taking medications that impact metabolism

Report sustained weight loss of >3% in the past 3 months.

History of metabolic/bariatric surgery.

Females who are pregnant, have been pregnant within the past 6 months, or plan to become pregnant during the study period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • natural glycemic control supplement

    Dietary supplement

    This trial will test the effectiveness of these unique compounds to improve postprandial glycemic excursion. This includes both long-term and acute control.

  • Placebo Multivitamin

    Dietary supplement

    This group will receive 90 days of a multivitamin placebo.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SupplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Interstitial Glucose

continuous glucose monitoring

Time frame
Continuous glucose monitoring will take place over the course of the 90 day intervention
2

Blood Biomarkers

Insulin, Glucagon, GLP-1, Ghrelin, Leptin, and other metabolic biomarkers will be analyzed as part of an acute mixed-meal tolerance test.

Time frame
Baseline (prior to any supplementation), then on day 45 of supplementation and on day 90 of supplementation. Each blood draw will be taken in the morning after an overnight fast and again 30 and 60 minutes after a standardized meal is consumed.

Secondary outcomes

1

Body Composition

Dual-energy X-ray Absorptiometry (DEXA) for assessment of body fat percentage, lean mass, and bone density.

Time frame
Baseline and at the end of the intervention
2

Dietary Patterns

Random 24-hour dietary recall to assess changes in dietary patterns over the 90-day intervention.

Time frame
5 dietary recalls over the 90 day intervention.
3

Participant Height

Height to the nearest tenth of a centimeter will be recorded using a standard wall-mounted sadometer

Time frame
At the baseline visit
4

Participant mass

Participant mass will be measured using a standard scientific weight scale and recorded to the nearest tenth of a kilogram.

Time frame
Baseline, Day 45 of intervention and day 90 of intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Alabama

Lead sponsor

HLTH Code, LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: