Lembas Edge™ for Appetite Control in Overweight Adults

CR
Overseen ByClinical Research Project Manager
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Lembas

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for healthy adults who are overweight. Participants should not have major health issues and must be willing to take a supplement or placebo twice daily, track their food intake, and monitor their weight and body composition regularly.

Inclusion Criteria

In good general health at the time of screening (Investigator discretion)
Able to use a personal smartphone device and download Chloe by People Science
Able to complete study assessments over the course of up to 30 weeks
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Exclusion Criteria

I have taken antibiotics, antifungals, or antivirals in the past 2 weeks.
Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes
New diagnosis workup planned during study that may change diagnosis, behavior, or medications
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What Are the Treatments Tested in This Trial?

Interventions

  • Lembas Edge™

Trial Overview

The study tests whether Lembas Edge™, a gut-active supplement meant to boost fullness hormones, can help reduce hunger in overweight adults compared to a placebo. Two doses of the supplement will be tested over 6 months with an optional 3-month extension.

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: Study Product High DoseActive Control1 Intervention
Group II: Study Product Medium DoseActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lembas

Lead Sponsor