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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postprandial Glycemic Control; Prediabetic Overweight and Obese Adults
• Intervention / Treatment: Dietary supplement: Low dose alpha-galactosidase-derived peptide; Dietary supplement: Medium dose alpha-galactosidase-derived peptide; Dietary supplement: High dose alpha-galactosidase-derived peptide; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Lewis; Phone Number: +248 1-226-242-4551; Email: elewis@kgkscience.com

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • KGK Science Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria Part 1:

1. Males & females 18 years and older

2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

   • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
   • Double-barrier method
   • Intrauterine devices
   • Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
   • Vasectomy of partner at least 6 months prior to screening
   • Abstinence and agrees to use contraception if planning on becoming sexually active during the study
3. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
4. Provided voluntary, written, informed consent to participate in the study
5. Healthy as determined by medical history as assessed by the Qualified Investigator (QI)

Inclusion Criteria Part 2:

1. Males & females 18 years and older
2. Body Mass Index (BMI) between 25.0 and 34.9 kg/m2

3. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

   • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
   • Double-barrier method
   • Intrauterine devices
   • Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
   • Vasectomy of partner at least 6 months prior to screening
   • Abstinence and agrees to use contraception if planning on becoming sexually active during the study
4. Hemoglobin A1c (HbA1c) of 5.7-6.4% at screening
5. Willingness to complete questionnaires, records and diaries associated with the study and to complete clinic visits
6. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
7. Provided voluntary, written, informed consent to participate in the study
8. Healthy as determined by medical history as assessed by the Qualified Investigator (QI)

Exclusion Criteria Part 1:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy (including alpha-gal syndrome), sensitivity, intolerance, or dietary restriction preventing consumption of investigational product
3. Unstable metabolic disease or chronic diseases as assessed by the QI
4. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
5. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
6. Type I or Type II diabetes
7. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
8. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
9. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
10. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
11. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
12. Individuals with an autoimmune disease or are immune compromised as assessed by the QI
13. Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
14. Self-reported confirmation of blood/bleeding disorders as assessed by the QI
15. Use of prescribed medical cannabinoid products
16. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
17. Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
18. Alcohol intake average of >2 standard drinks per day as assessed by the QI
19. Alcohol or drug abuse within the last 12 months
20. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the safety of the investigational product (Sections 7.3.1 and 7.3.2)
21. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
22. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
23. Individuals who are unable to give informed consent
24. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Exclusion Criteria Part 2:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy (including alpha-gal syndrome), sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients or the standardized meal
3. Poor venous access as assessed by the QI
4. Change in body weight greater than 5 kg within 3 months prior to starting study
5. Currently on or planning to initiate a body weight reduction diet during the study
6. Self reported vigorous exercise >120 minutes/week
7. Obesity induced by endocrinologic or genetic disorders or monogenetic or syndromic forms of obesity
8. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
9. Unstable metabolic disease or chronic diseases, including pancreatitis, as assessed by the QI
10. Current diagnosis with gastroesophageal reflux disease (GERD) or hiatal hernia
11. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
12. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
13. Type I or Type II diabetes
14. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
15. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
16. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
17. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
18. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
19. Individuals with an autoimmune disease or are immune compromised as assessed by the QI
20. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
21. Self-reported confirmation of blood/bleeding disorders as assessed by the QI
22. Use of prescribed medical cannabinoid products
23. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
24. Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
25. Alcohol intake average of >2 standard drinks per day as assessed by the QI
26. Alcohol or drug abuse within the last 12 months
27. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the glucose metabolism or efficacy of the investigational product (Sections 7.3.1 and 7.3.2)
28. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
29. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
30. Individuals who are unable to give informed consent
31. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose Lembas Edge; Participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.	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.
Experimental: Medium Dose Lembas Edge; 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.
Experimental: High Dose Lembas Edge; 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: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-emergent adverse events (AE)	Part 1. Incidence of post-emergent adverse events (AE)	Day 0 to 14
Clinically relevant changes in blood pressure after supplementation	Part 1. Clinically relevant changes in blood pressure (mmHg) after supplementation	Day 0 to 14
Clinically relevant changes in heart rate after supplementation	Part 1. Clinically relevant changes in heart rate (beats per minute) after supplementation	Day 0 to 14
Clinically relevant changes in aspartate aminotransferase	Part 1. Clinically relevant changes in aspartate aminotransferase (U/L) after supplementation.	Day 0 to 14
Clinically relevant changes in alanine aminotransferase	Part 1. Clinically relevant changes in alanine aminotransferase (U/L) after supplementation.	Day 0 to 14
Clinically relevant changes in alkaline phosphatase	Part 1. Clinically relevant changes in alkaline phosphatase (U/L) after supplementation.	Day 0 to 14
Clinically relevant changes in total bilirubin	Part 1. Clinically relevant changes in total bilirubin (micromole/litre) after supplementation.	Day 0 to 14
Clinically relevant changes in creatinine	Part 1. Clinically relevant changes in creatinine (micromole/litre) after supplementation.	Day 0 to 14
Clinically relevant changes in sodium	Part 1. Clinically relevant changes in sodium (mmol/L) after supplementation.	Day 0 to 14
Clinically relevant changes in potassium	Part 1. Clinically relevant changes in potassium (mmol/L) after supplementation.	Day 0 to 14
Clinically relevant changes in chloride	Part 1. Clinically relevant changes in chloride (mmol/L) after supplementation.	Day 0 to 14
Clinically relevant changes in estimated glomerular filtration rate	Part 1. Clinically relevant changes in estimated glomerular filltration rate (mL/min/1.73 m^2) after supplementation.	Day 0 to 14
Clinically relevant changes in glucose	Part 1. Clinically relevant changes in glucose (mmol/L) after supplementation.	Day 0 to 14
Clinically relevant changes in red blood cell count	Part 1. Clinically relevant changes in red blood cell count (x 10^12/L) after supplementation	Day 0 to 14
Clinically relevant changes in white blood cell count	Part 1. Clinically relevant changes in white blood cell count (x 10^9/L) after supplementation	Day 0 to 14
Clinically relevant changes in platelet count	Part 1. Clinically relevant changes in platelet count (x 10^9/L) after supplementation	Day 0 to 14
Clinically relevant changes in hemoglobin	Part 1. Clinically relevant changes in hemoglobin (g/L) after supplementation	Day 0 to 14
Clinically relevant changes in hematocrit	Part 1. Clinically relevant changes in hematocrit (L/L) after supplementation	Day 0 to 14
Clinically relevant changes in red blood cell indices (MCV - Mean Corpuscular Volume)	Part 1. Clinically relevant changes in MCV (fL) after supplementation	Day 0 to 14
Clinically relevant changes in red blood cell indices (MCH - Mean Corpuscular Hemoglobin)	Part 1. Clinically relevant changes in MCH (pg) after supplementation	Day 0 to 14
Clinically relevant changes in red blood cell indices (MCHC - Mean Corpuscular Hemoglobin Concentration)	Part 1. Clinically relevant changes in MCHC (g/L) after supplementation	Day 0 to 14
Clinically relevant changes in RDW - Red Cell Distribution Width	Part 1. Clinically relevant changes in RDW (%) after supplementation	Day 0 to 14
Clinically relevant changes in red blood cell indices (MPV - Mean Platelet Volume)	Part 1. Clinically relevant changes in MPV (fL) after supplementation	Day 0 to 14
The difference in postprandial glucose between Lembas Edge and placebo	Part 2. The difference in postprandial glucose, as assessed by incremental area under the curve (iAUC) (0-120 min), between Lembas Edge (high dose, medium dose, low dose) and placebo.	Visit 2 (day 1) to Visit 5 (day 22)
The height of the postprandial glucose peak and nadir post meal between Lembas Edge and placebo	Part 2. The height of the postprandial glucose peak and nadir post meal between Lembas Edge (high dose, medium dose, low dose) and placebo.	Visit 2 (day 1) to Visit 5 (day 22)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in postprandial glucose iAUC (0-240 min) between Lembas Edge and placebo	Part 2. The difference in postprandial glucose, as assessed by iAUC (0-240 min), between Lembas Edge (high dose, medium dose, low dose) and placebo	Visit 2 (day 1) to Visit 5 (day 22)
The difference in postprandial insulin between Lembas Edge and placebo	Part 2. The difference in postprandial insulin, as assessed by iAUC (0-120 min) and iAUC (0-240 min), between Lembas Edge (high dose, medium dose, low dose) and placebo	Visit 2 (day 1) to Visit 5 (day 22)
The difference in self-reported satiety scores between Lembas Edge and placebo	Part 2. The difference in self-reported satiety scores, as assessed by iAUC (0-240 min), between Lembas Edge (high dose, medium dose, low dose) and placebo	Visit 2 (day 1) to Visit 5 (day 22)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting glucose from baseline to day 14 after supplementation	Part 1. The change in fasting glucose from baseline to day 14 after supplementation	Day 0 to 14
Change in fasting insulin from baseline to day 14 after supplementation	Part 1. The change in fasting insulin from baseline to day 14 after supplementation	Day 0 to 14
Change in fasting HOMA-IR from baseline to day 14 after supplementation	Part 1. The change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from baseline to day 14 after supplementation	Day 0 to 14
Part 2. Incidence of post-emergent adverse events (AE)	Part 2. Incidence of post-emergent adverse events (AE)	Visit 1 (day -45 to -1) to visit 5 (day 22)
The difference in postprandial peptide YY (PYY) between Lembas Edge and placebo	Part 2. The difference in postprandial PYY, as assessed by iAUC (0-240 min), between Lembas Edge (high dose, medium dose, low dose) and placebo	Day 1 to 22
The difference in postprandial GIP (Glucose-Dependent Insulinotropic Polypeptide) between Lembas Edge and placebo	Part 2. The difference in postprandial GIP, as assessed by iAUC (0-240 min), between Lembas Edge (high dose, medium dose, low dose) and placebo	Day 1 to 22
The difference in postprandial Glucagon-Like Peptide-1 (GLP-1) between Lembas Edge and placebo	Part 2. The difference in postprandial GLP-1, as assessed by iAUC (0-240 min), between Lembas Edge (high dose, medium dose, low dose) and placebo	Day 1 to 22

Collaborators and Investigators

• Sponsor: Lembas
• Collaborators: KGK Science Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: postprandial glycemic control; prediabetic overweight and obese adults; Lembas
• Other Study ID Numbers: 26LBKGR01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No