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

17 september 2026 bijgewerkt door: Landon Deru, University of South Alabama

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Participants will enroll in this randomized, double-blind, placebo-controlled, parallel-group trial in which they will consume the assigned intervention daily, 15 minutes before their largest meal. Continuous glucose monitoring will be used to characterize glucose responses under real-world conditions. Repeated blood draws will quantify changes in metabolic hormones and inflammatory biomarkers during three distinct standardized meal tests. These tests will take place at baseline, 45 days, and 90 days of supplementation. DEXA scans and anthropometric measurements, such as waist circumfrance, will assess body composition changes. Dietary recalls will be collected to evaluate behavioral changes and dietary adherence. Activity monitors will be used to assess physical activity and sleep patterns.

Assessments:

Visit 1 (Baseline) - morning visit

  • Informed consent
  • DEXA scan (fasted)
  • Waist and hip circumference
  • Placement of CGM #1

Visit 2 (Day 2) - morning visit

  • Fasted Standardized meal test
  • Pre-test blood draw, 30 minutes post blood draw, 1 hour post blood draw
  • During the resting/waiting period:
  • Give activity tracker and orient to dietary tracking. Ensure CGM functionality.

Visit 3 (Day 15)

  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 4 (Day 30)

  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 5 (Day 45- halfway point)

  • Fasted standardized meal and blood draws
  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 6 (Day 60)

  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 7 (Day 75)

  • Check symptoms and adverse events
  • Replace glucose monitor
  • Dietary tracking and physical activity education

Visit 8 (Day 90)

  • Fasted standardized meal and blood draws
  • Waist and hip circumference measurements
  • DEXA scan
  • Collect equipment and supplies back from participant

Visit 9 (Day 91)

• CGM removal (Full 24 hr after intervention)

STATISTICAL ANALYSIS PLAN

Primary Outcome:

Change in acute fasted glucose AUC at baseline, Day 45 and Day 90.

Primary Analysis:

Mixed-effects linear model with:

  • Fixed effects: group, time, group × time
  • Random effect: participant

Secondary Analyses:

  • Repeated-measures mixed models for hormones
  • Repeated-measures mixed models for body composition
  • ANCOVA models controlling for baseline values
  • Sensitivity analyses for dietary intake and adherence
  • Physical Activity data as a covariate with glucose data

Power Analysis:

Assuming an effect size of d=0.60, alpha=0.05, and 80% power, 52 participants are required. Enrollment of 60 participants allows for approximately 15% attrition.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • BMI 25-40 kg/m²
  • Ability to provide informed consent

Exclusion Criteria:

  • 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.
  • Report a current medical condition or treatment for a medical condition that could affect body weight or contradict engagement in any aspect of the outcome measures or interventions.
  • Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction or history of cardiomyopathy, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).
  • Resting systolic blood pressure of >160 mmHg or resting diastolic blood pressure of >100 mmHg. If medicated for blood pressure control, the medication dose needs to be stable for >6 months.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Supplement

This group receives the supplement for 90 days
Voedingssupplement: natural glycemic control 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-vergelijker: Placebo

This group receives the placebo for 90 days
Voedingssupplement: Placebo Multivitamin

This group will receive 90 days of a multivitamin placebo.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Interstitial Glucose
Tijdsspanne: Continuous glucose monitoring will take place over the course of the 90 day intervention

continuous glucose monitoring
Continuous glucose monitoring will take place over the course of the 90 day intervention
Blood Biomarkers
Tijdsspanne: 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.

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body Composition
Tijdsspanne: Baseline and at the end of the intervention

Dual-energy X-ray Absorptiometry (DEXA) for assessment of body fat percentage, lean mass, and bone density.
Baseline and at the end of the intervention
Dietary Patterns
Tijdsspanne: 5 dietary recalls over the 90 day intervention.

Random 24-hour dietary recall to assess changes in dietary patterns over the 90-day intervention.
5 dietary recalls over the 90 day intervention.
Participant Height
Tijdsspanne: At the baseline visit

Height to the nearest tenth of a centimeter will be recorded using a standard wall-mounted sadometer
At the baseline visit
Participant mass
Tijdsspanne: Baseline, Day 45 of intervention and day 90 of intervention

Participant mass will be measured using a standard scientific weight scale and recorded to the nearest tenth of a kilogram.
Baseline, Day 45 of intervention and day 90 of intervention
Waist circumfrence
Tijdsspanne: Baseline and at 45 days and 90 days of intervention.

Participants' waist circumferences will be measured using a standard flexible PVC measuring tape around the umbilicus and at the level of the iliac crest.
Baseline and at 45 days and 90 days of intervention.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of South Alabama

Medewerkers

HLTH Code, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

9 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 september 2026

Eerst geplaatst (Werkelijk)

24 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

17 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • TBD-IRB in Progress

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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