Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

7. listopadu 2026 aktualizováno: 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

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

150

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo

A placebo supplement that looks and tastes like the study product but does not any active ingredients.

Aktivní komparátor: 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.

Aktivní komparátor: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 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)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Assessment of patient satisfaction survey of study experience including design and use of app-based data collection tools
Časové okno: 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.
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. listopadu 2026

Primární dokončení (Odhadovaný)

1. července 2027

Dokončení studie (Odhadovaný)

1. října 2027

Termíny zápisu do studia

První předloženo

7. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

7. listopadu 2026

První zveřejněno (Aktuální)

13. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

Beginning 6 months after publication of the primary results, for 5 years.

Kritéria přístupu pro sdílení IPD

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.

Typ podpůrných informací pro sdílení IPD

  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit