The Impact of a Daily Dietary Supplement on Glycemic Control in Individuals With Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Interstitial Glucose
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 25-40 kg/m²
- •Ability to provide informed consent
排除标准
- •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.
研究组 & 干预措施
Supplement
This group receives the supplement for 90 days
干预措施: natural glycemic control supplement (Dietary Supplement)
Placebo
This group receives the placebo for 90 days
干预措施: Placebo Multivitamin (Dietary Supplement)
结局指标
主要结局
Interstitial Glucose
时间窗: Continuous glucose monitoring will take place over the course of the 90 day intervention
continuous glucose monitoring
Blood Biomarkers
时间窗: 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.
次要结局
- Body Composition(Baseline and at the end of the intervention)
- Dietary Patterns(5 dietary recalls over the 90 day intervention.)
- Participant Height(At the baseline visit)
- Participant mass(Baseline, Day 45 of intervention and day 90 of intervention)
- Waist circumfrence(Baseline and at 45 days and 90 days of intervention.)
研究者
Landon Deru
Assistant Professor
University of South Alabama