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Effects of a Gut-Active Peptide That Stimulates GLP-1 Release on Appetite and Satiety in Healthy Adults With Overweight

2026年11月7日 更新者:Lembas

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:

  1. Does taking Lembas Edge™ help reduce hunger and improve feelings of fullness (appetite and satiety)?
  2. 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:

  1. 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
  2. Log their daily meals and snacks and confirm when they take their product using a smartphone app
  3. Weigh themselves and check their body composition weekly using a special scale provided by the study
  4. Answer weekly and monthly surveys about their hunger levels, food thoughts, digestion, and any health symptoms

調査の概要

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

介入

入学 (推定)

150

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • California
      • Los Angeles、California、アメリカ、90045

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Individuals 18-65 years of age
  2. Individuals with a BMI of 25-35 kg/m2 from self-reported weight and height measured within the last 6 months prior to randomization
  3. In good general health at the time of screening (Investigator discretion).
  4. Able to read and understand English and provide informed consent.
  5. Able to use a personal smartphone device and download Chloe by People Science
  6. Able to receive shipment of the product at an address within the United States.
  7. Able to complete study assessments over the course of up to 30 weeks.
  8. Willing to measure weight weekly using provisioned bioimpedance scale.

Exclusion Criteria:

  1. Do not have a personal smartphone, internet access, or unwilling to download Chloe.
  2. 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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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

武器と介入

参加者グループ / アーム
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.

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

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

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)
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

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

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月1日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2027年10月1日

試験登録日

最初に提出

2026年11月7日

QC基準を満たした最初の提出物

2026年11月7日

最初の投稿 (実際)

2026年11月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月13日

QC基準を満たした最後の更新が送信されました

2026年11月7日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

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?

はい

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

いいえ

米国FDA規制機器製品の研究

いいえ

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