The Impact of a Daily Dietary Supplement on Glycemic Control in Individuals With Overweight or Obesity
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Landon Deru, PhD
- Número de telefone: 251-341-3849
- E-mail: deru@southalabama.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Supplement
This group receives the supplement for 90 days |
This trial will test the effectiveness of these unique compounds to improve postprandial glycemic excursion. This includes both long-term and acute control. |
|
Comparador de Placebo: Placebo
This group receives the placebo for 90 days |
This group will receive 90 days of a multivitamin placebo. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Interstitial Glucose
Prazo: 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
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Composition
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
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Palavras-chave
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- TBD-IRB in Progress
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