Effects of a Gut-Active Peptide That Stimulates GLP-1 Release on Appetite and Satiety in Healthy Adults With Overweight
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Impact of 2 Doses of Lembas Edge™ Supplementation in Healthy Overweight Individuals
The goal of this study is to see if a daily supplement called Lembas Edge™ helps control appetite and fullness in healthy adults who are overweight. The main questions it aims to answer are:
- Does taking Lembas Edge™ help reduce hunger and improve feelings of fullness (appetite and satiety)?
- How does the supplement affect body weight, body mass index (BMI), waist size, food cravings ("food noise"), and digestion?
Researchers will compare two different doses of Lembas Edge™ to a placebo (a pill that looks identical but contains no active supplement) to see how well it works.
Participants will be asked to:
- Take the study supplement or placebo twice a day (once in the morning and once in the afternoon) for 6 months, with an option to continue in an "open label extension" for an extra 3 months
- Log their daily meals and snacks and confirm when they take their product using a smartphone app
- Weigh themselves and check their body composition weekly using a special scale provided by the study
- Answer weekly and monthly surveys about their hunger levels, food thoughts, digestion, and any health symptoms
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The rationale for this study is to observe safe, well-tolerated nutritional intervention that support appetite regulation, satiety, and long-term weight control. The current study aims to evaluate the impact of an investigational supplement, Lembas Edge™, on satiety-related outcomes and body weight relevant to weight management in overweight and mildly obese healthy adults. The safety profile will be measured via activities and technologies that can successfully and effectively be completed and utilized in a home setting.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:Clinical Research Project Manager
- 電話番号:(213) 785-7755
- メール:ps44lembasedgestudy@peoplescience.health
研究場所
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California
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Los Angeles、California、アメリカ、90045
- People Science
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主任研究者:
- Noah Craft, MD, PhD
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コンタクト:
- Clinical Research Project Manager
- 電話番号:(213) 785-7755
- メール:ps44lembasedgestudy@peoplescience.health
-
-
参加基準
適格基準
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:
- Individuals 18-65 years of age
- Individuals with a BMI of 25-35 kg/m2 from self-reported weight and height measured within the last 6 months prior to randomization
- In good general health at the time of screening (Investigator discretion).
- Able to read and understand English and provide informed consent.
- Able to use a personal smartphone device and download Chloe by People Science
- Able to receive shipment of the product at an address within the United States.
- Able to complete study assessments over the course of up to 30 weeks.
- Willing to measure weight weekly using provisioned bioimpedance scale.
Exclusion Criteria:
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Concomitant Therapies: Participants receiving any of the following treatments or therapies are excluded:
2a. Any investigational therapies or treatments (pharmaceuticals, devices, supplements) within 90 days prior to randomization.
2b. Treatment with Glucagon-like peptide-1 (GLP-1) agonists (Semaglutide (Ozempic, Wegovy, Rybelsus), Tirzepatide (Mounjaro, Zepbound), Liraglutide (Victoza, Saxenda), Dulaglutide (Trulicity), Exenatide (Byetta, Bydureon BCise), Orforglipon, Cagrilintine/Semaglutide (CagriSema)) within the last 90 days prior to randomization.
3. Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses (GI) are excluded: 3a. Currently diagnosed with Type I or Type II Diabetes 3b. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder 3c. Currently pregnant, planning to become pregnant in the next 9 months, or breastfeeding 3d. History of bariatric or other significant gastrointestinal surgery (e.g., small bowel resection, total colectomy) that has permanently altered GI anatomy or function. Standard appendectomy or cholecystectomy are generally permitted.
3e. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes 3f. New diagnosis workup planned during study that may change diagnosis/ behavior/ medications (eg. colonoscopy prep or major bowel cleanse, upcoming GI consult that could affect eligibility).
3g. Have a significant illness, disease or condition which, in the opinion of the Principal Investigator, may impact their ability to participate in the study or impact the study outcomes.
4. Participants who are on, plan to initiate, or have recently completed (within the last 3 months) a major restrictive or elimination diet, or a structured weight-loss diet (i.e keto diet, pure carnivore diet, raw food diet, fruitarian diet, liquid diet) during the study period.
5. Use of any antibiotics, antifungals, or antivirals within 2 weeks prior to randomization.
6. Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator 7. Allergy (including alpha-gal syndrome), sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients 8. Implanted electronic devices, such as a cardiac pacemaker, cochlear implant, or an implanted defibrillator, that might be contraindicated for use with the bioimpedance scale used in the study (nonelectronic metal implants such as nails, screws, plates, metal braces are OK)
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:基礎科学
- 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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
プラセボコンパレーター:プラセボ
|
A placebo supplement that looks and tastes like the study product but does not any active ingredients. |
|
アクティブコンパレータ:Study Product High Dose
|
Lembas Edge™ is a supplement containing a naturally-derived amino acid peptide fragment, which has been previously studied in gastrointestinal applications and demonstrated a well-established safety profile. |
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アクティブコンパレータ:Study Product Medium Dose
|
Lembas Edge™ is a supplement containing a naturally-derived amino acid peptide fragment, which has been previously studied in gastrointestinal applications and demonstrated a well-established safety profile. |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in the Flint Visual Analogue Scale (VAS) score as measured by the change in the appetite assessment score between study product and placebo groups. Baseline period will be compared as well.
時間枠:From Baseline to the end of the Product/Placebo Use Period (6 months)
|
The Flint Visual Analogue Scale (VAS) consists of 8 questions scored from 0 to 100. Each question uses a slider where the left and right endpoints represent opposite extremes of hunger, fullness, and specific food cravings. |
From Baseline to the end of the Product/Placebo Use Period (6 months)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Gastrointestinal Symptom Rating Scale (GSRS) score at the end of 6 months between study product and placebo groups. Baseline period will be compared as well.
時間枠:From Baseline to the end of the Product/Placebo Use Period (6 months)
|
The Gastrointestinal Symptom Rating Scale is a 15-item questionnaire that participants complete about digestive symptoms over the past week (reflux, abdominal pain, indigestion, diarrhea and constipation). Each item is scored from 1 (no discomfort) to 7 (very severe discomfort). Higher scores mean worse symptoms. |
From Baseline to the end of the Product/Placebo Use Period (6 months)
|
|
Change from baseline in waist-to-height ratio (WtHR) using provisioned tape at the end of 6 months between study product and placebo groups.
時間枠:From Baseline to the end of the Product/Placebo Use Period (6 months)
|
A body tape measure and a height ruler is provided to measure waist circumference and height. A higher ratio means a larger waist relative to height. |
From Baseline to the end of the Product/Placebo Use Period (6 months)
|
|
Change in Ro Allison Indiana Dhurandhar Food Noise (RAID-FN) Inventory score at the end of 6 months between study product and placebo groups, as well as trend over time. Baseline period will be compared as well.
時間枠:From Baseline to the end of the Product/Placebo Use Period (6 months)
|
The RAID-FN measure "food noise" intensity and contains 29 items total, ranking items on a 5-point Likert scale. |
From Baseline to the end of the Product/Placebo Use Period (6 months)
|
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Change from baseline in weight and BMI using a provisioned scale at the end of 6 months between study product and placebo groups
時間枠:From Baseline to the end of the Product/Placebo Use Period (6 months)
|
Body mass index is calculated automatically from weight and height captured by a study-provided scale and self-measured height. |
From Baseline to the end of the Product/Placebo Use Period (6 months)
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of patient satisfaction survey of study experience including design and use of app-based data collection tools
時間枠:End of the Product/Placebo Use Period (Month 6)
|
End of the Product/Placebo Use Period (Month 6)
|
|
|
Change from baseline in body composition analysis using a provisioned bioimpedance scale at the end of 6 months between study product and placebo groups.
時間枠:From Baseline to the end of the Product/Placebo Use Period (6 months)
|
Participants measure body composition (such as body fat, muscle mass and body water) on a study-provided bioimpedance scale. |
From Baseline to the end of the Product/Placebo Use Period (6 months)
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
- Karlsson J, Persson LO, Sjostrom L, Sullivan M. Psychometric properties and factor structure of the Three-Factor Eating Questionnaire (TFEQ) in obese men and women. Results from the Swedish Obese Subjects (SOS) study. Int J Obes Relat Metab Disord. 2000 Dec;24(12):1715-25. doi: 10.1038/sj.ijo.0801442.
- Kulich KR, Madisch A, Pacini F, Pique JM, Regula J, Van Rensburg CJ, Ujszaszy L, Carlsson J, Halling K, Wiklund IK. Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study. Health Qual Life Outcomes. 2008 Jan 31;6:12. doi: 10.1186/1477-7525-6-12.
- Wang Y, Beydoun MA, Min J, Xue H, Kaminsky LA, Cheskin LJ. Has the prevalence of overweight, obesity and central obesity levelled off in the United States? Trends, patterns, disparities, and future projections for the obesity epidemic. Int J Epidemiol. 2020 Jun 1;49(3):810-823. doi: 10.1093/ije/dyz273.
- Caballero B. Humans against Obesity: Who Will Win? Adv Nutr. 2019 Jan 1;10(suppl_1):S4-S9. doi: 10.1093/advances/nmy055.
- Schneider KL, Bodenlos JS, Ma Y, Olendzki B, Oleski J, Merriam P, Crawford S, Ockene IS, Pagoto SL. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder. BMC Psychiatry. 2008 Sep 15;8:77. doi: 10.1186/1471-244X-8-77.
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- PS44
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?
IPD プランの説明
De-identified individual participant data underlying the results reported in the primary publication will be shared on request. The informed consent form will also be available.
IPD 共有時間枠
Beginning 6 months after publication of the primary results, for 5 years.
IPD 共有アクセス基準
Qualified researchers who submit a methodologically sound proposal to the study contact and sign a data use agreement. Requesters may bear the cost of preparing and transferring the data.
IPD 共有サポート情報タイプ
- ICF
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。