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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Clinical Research Project Manager
- Telefonnummer: (213) 785-7755
- E-post: ps44lembasedgestudy@peoplescience.health
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90045
- People Science
-
Hovedetterforsker:
- Noah Craft, MD, PhD
-
Ta kontakt med:
- Clinical Research Project Manager
- Telefonnummer: (213) 785-7755
- E-post: ps44lembasedgestudy@peoplescience.health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
A placebo supplement that looks and tastes like the study product but does not any active ingredients. |
|
Aktiv komparator: 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. |
|
Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of patient satisfaction survey of study experience including design and use of app-based data collection tools
Tidsramme: 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.
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PS44
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
Beginning 6 months after publication of the primary results, for 5 years.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .