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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Landon Deru, PhD
- 電話番号：251-341-3849
- メール：deru@southalabama.edu
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
プラセボコンパレーター：Placebo
This group receives the placebo for 90 days |
This group will receive 90 days of a multivitamin placebo. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Interstitial Glucose
時間枠：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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body Composition
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
協力者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- TBD-IRB in Progress
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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