Lembas Edge for Prediabetes

EL
Overseen ByErin Lewis
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 part 1 of this clinical trial is to investigate the tolerability of Lembas Edge in healthy adults. The objective of Part 2 of this study is to investigate the efficacy of Lembas Edge on postprandial glycemic control in prediabetic overweight and obese adults. The main questions it aims to answer are:

* What is the tolerability of Lembas Edge?

* What is the efficacy of Lembas Edge on postprandial glycemic control?

Researchers will compare Lembas Edge to placebo to see its effects. Participants will be asked to:

* Provide blood samples.

* Record their food and beverage intake in Part 2.

* Complete a satiety questionnaire in Part 2.

* Consume Lembas Edge or placebo as instructed.

Are You a Good Fit for This Trial?

This trial is for healthy adults (Part 1) and overweight or obese adults with prediabetes (Part 2). Participants should not have other major health issues. People who are pregnant, breastfeeding, or have certain medical conditions may be excluded.

Inclusion Criteria

Healthy as determined by medical history assessed by Qualified Investigator (QI)
I am not able to become pregnant, or I use birth control and have a negative pregnancy test.
Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, sleep) throughout the study
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Exclusion Criteria

Individuals who are pregnant, breastfeeding, or planning pregnancy during the study
Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients or standardized meal
I have Type 1 or Type 2 diabetes.
See 28 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests different doses of a new supplement called Lembas Edge against a placebo. It first checks if the supplement is safe in healthy people, then sees if it helps control blood sugar after meals in prediabetic individuals.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Medium Dose Lembas EdgeExperimental Treatment1 Intervention
Group II: Low Dose Lembas EdgeExperimental Treatment1 Intervention
Group III: High Dose Lembas EdgeExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lembas

Lead Sponsor

KGK Science Inc.

Industry Sponsor

Trials
82
Recruited
6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution