Lembas Edge for Prediabetes
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
Exclusion Criteria
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
Participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
Participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
In part 1, participants will be instructed to take 3 capsules daily (as a single dose) in the morning until the day prior to their end of study visit (Day 13). In part 2, participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
In part 1, participants will be instructed to take 3 capsules daily (as a single dose) in the morning until the day prior to their end of study visit (Day 13). In part 2, participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lembas
Lead Sponsor
KGK Science Inc.
Industry Sponsor
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
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