Effects of a Gut-Active Peptide That Stimulates GLP-1 Release on Appetite and Satiety in Healthy Adults With Overweight
A legfontosabb adatok
- Ki végzi
- Lembas
- Hol
- Los Angeles (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 150 fő, tervezett
- Kezdés
- 2026. nov.
- Várható befejezés
- 2027. okt.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Lembas Edge™
- Placebo
- A regiszteradat frissítve
- 2026. november 13.
Ki vehet részt
- Életkor
- 18 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
- Use of any antibiotics, antifungals, or antivirals within 2 weeks prior to randomization
- 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)
- 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
- Do not have a personal smartphone, internet access, or unwilling to download Chloe
- 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
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 65 év között vagy?
Helyszínek itt: Egyesült Államok
- People ScienceLos Angeles, Egyesült ÁllamokContact: Clinical Research Project ManagerNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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:
A teljes eredeti leírásKevesebb
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
A vizsgálat 3 csoportja
- Study Product High DoseMár használt kezelés, összehasonlításként
Kezelés: Lembas Edge™
- Study Product Medium DoseMár használt kezelés, összehasonlításként
Kezelés: Lembas Edge™
- PlaceboPlacebo, összehasonlításként
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Randomized, Double-blind, Placebo-controlled Study Evaluating the Impact of 2 Doses of Lembas Edge™ Supplementation in Healthy Overweight Individuals
- Illeszkedési kérdések
- Forrás: NCT07936838: ki vehet részt
- A regiszteradat frissítve
- 2026. november 13.