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A Two-part Study of Lembas Edge Evaluating Tolerability and Postprandial Glycemic Control

NCT07711288 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-07-17

No results posted yet for this study

Summary

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.

Conditions

  • Postprandial Glycemic Control
  • Prediabetic Overweight and Obese Adults

Interventions

DIETARY_SUPPLEMENT

Low dose alpha-galactosidase-derived peptide

Participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.

DIETARY_SUPPLEMENT

Medium dose alpha-galactosidase-derived peptide

Participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.

DIETARY_SUPPLEMENT

High dose alpha-galactosidase-derived peptide

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.

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Lembas

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07711288 on ClinicalTrials.gov