Can a peptide supplement tame blood sugar spikes?
NCT ID NCT07711288
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This two-part study investigates Lembas Edge, a dietary supplement derived from a peptide. Part 1 tests its safety and tolerability in healthy adults. Part 2 evaluates its ability to control blood sugar after meals in overweight or obese adults with prediabetes. Participants take the supplement or a placebo before a meal, and researchers measure blood sugar and insulin responses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- alpha-galactosidase-derived peptide (Lembas Edge)
- What this could lead to
- If successful, this supplement could offer a new way to help manage blood sugar spikes after meals in people with prediabetes.
- What could go wrong
- This is an early, small study. The supplement may not prove effective, and results may not apply to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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KGK Science Inc.
London, Ontario, Canada
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