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Postprandial Glycemic ControlNCT07711288

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

A study testing Low dose alpha-galactosidase-derived peptide, Medium dose alpha-galactosidase-derived peptide and High dose alpha-galactosidase-derived peptide in people with Postprandial Glycemic Control and Prediabetic Overweight and Obese Adults, run by Lembas at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Low dose alpha-galactosidase-derived peptide, Medium dose alpha-galactosidase-derived peptide and High dose alpha-galactosidase-derived peptide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteCanada
Study dates
Oct 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males \& females 18 years and older
  • 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)
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  • 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
  • Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
  • Provided voluntary, written, informed consent to participate in the study
  • Healthy as determined by medical history as assessed by the Qualified Investigator (QI)
  • Males \& females 18 years and older
  • Body Mass Index (BMI) between 25.0 and 34.9 kg/m2
  • 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
  • Hemoglobin A1c (HbA1c) of 5.7-6.4% at screening
  • Willingness to complete questionnaires, records and diaries associated with the study and to complete clinic visits
  • Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
  • Provided voluntary, written, informed consent to participate in the study
  • Healthy as determined by medical history as assessed by the Qualified Investigator (QI)

Who cannot join

  • Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  • Allergy (including alpha-gal syndrome), sensitivity, intolerance, or dietary restriction preventing consumption of investigational product
  • Unstable metabolic disease or chronic diseases as assessed by the QI
  • Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
  • Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
  • Type I or Type II diabetes
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  • 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
  • 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
  • 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
  • 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
  • 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
  • Individuals with an autoimmune disease or are immune compromised as assessed by the QI
  • Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
  • Self-reported confirmation of blood/bleeding disorders as assessed by the QI
  • Use of prescribed medical cannabinoid products
  • Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
  • 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
  • Alcohol intake average of >2 standard drinks per day as assessed by the QI
  • Alcohol or drug abuse within the last 12 months
  • 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)
  • Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
  • Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  • Individuals who are unable to give informed consent
  • 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
  • Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  • Allergy (including alpha-gal syndrome), sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients or the standardized meal
  • Poor venous access as assessed by the QI
  • Change in body weight greater than 5 kg within 3 months prior to starting study
  • Currently on or planning to initiate a body weight reduction diet during the study
  • Self reported vigorous exercise >120 minutes/week
  • Obesity induced by endocrinologic or genetic disorders or monogenetic or syndromic forms of obesity
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Unstable metabolic disease or chronic diseases, including pancreatitis, as assessed by the QI
  • Current diagnosis with gastroesophageal reflux disease (GERD) or hiatal hernia
  • Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
  • Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
  • Type I or Type II diabetes
  • 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
  • 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
  • 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
  • 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
  • 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
  • Individuals with an autoimmune disease or are immune compromised as assessed by the QI
  • Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
  • Self-reported confirmation of blood/bleeding disorders as assessed by the QI
  • Use of prescribed medical cannabinoid products
  • Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
  • 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
  • Alcohol intake average of >2 standard drinks per day as assessed by the QI
  • Alcohol or drug abuse within the last 12 months
  • 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)
  • Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
  • Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  • Individuals who are unable to give informed consent
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Erin Lewis contact

+248 1-226-242-4551

elewis@kgkscience.com

Canada1 site

  • KGK Science Inc.

    London, Ontario

Other trials in Canada

About this study

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.
Being tested
Low dose alpha-galactosidase-derived peptide, Medium dose alpha-galactosidase-derived peptide, High dose alpha-galactosidase-derived peptide, Placebo
Keywords
prediabetic overweight and obese adults, postprandial glycemic control, Lembas

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose alpha-galactosidase-derived peptideDietary supplement

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

  • Medium dose alpha-galactosidase-derived peptideDietary supplement

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

  • High dose alpha-galactosidase-derived peptideDietary supplement

    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.

  • PlaceboDietary supplement

    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.

Study groups in NCT07711288
Study groupRoleWhat they receive
Low Dose Lembas EdgeExperimentalParticipants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
Receives: Dietary Supplement: Low dose alpha-galactosidase-derived peptide
Medium Dose Lembas EdgeExperimentalParticipants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
Receives: Dietary Supplement: Medium dose alpha-galactosidase-derived peptide
High Dose Lembas EdgeExperimentalIn 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.
Receives: Dietary Supplement: High dose alpha-galactosidase-derived peptide
PlaceboPlacebo comparatorIn 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.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of post-emergent adverse events (AE)

    Part 1. Incidence of post-emergent adverse events (AE)

    Measured: Day 0 to 14

  2. Clinically relevant changes in blood pressure after supplementation

    Part 1. Clinically relevant changes in blood pressure (mmHg) after supplementation

    Measured: Day 0 to 14

  3. Clinically relevant changes in heart rate after supplementation

    Part 1. Clinically relevant changes in heart rate (beats per minute) after supplementation

    Measured: Day 0 to 14

  4. Clinically relevant changes in aspartate aminotransferase

    Part 1. Clinically relevant changes in aspartate aminotransferase (U/L) after supplementation.

    Measured: Day 0 to 14

  5. Clinically relevant changes in alanine aminotransferase

    Part 1. Clinically relevant changes in alanine aminotransferase (U/L) after supplementation.

    Measured: Day 0 to 14

  6. Clinically relevant changes in alkaline phosphatase

    Part 1. Clinically relevant changes in alkaline phosphatase (U/L) after supplementation.

    Measured: Day 0 to 14

  7. Clinically relevant changes in total bilirubin

    Part 1. Clinically relevant changes in total bilirubin (micromole/litre) after supplementation.

    Measured: Day 0 to 14

  8. Clinically relevant changes in creatinine

    Part 1. Clinically relevant changes in creatinine (micromole/litre) after supplementation.

    Measured: Day 0 to 14

  9. Clinically relevant changes in sodium

    Part 1. Clinically relevant changes in sodium (mmol/L) after supplementation.

    Measured: Day 0 to 14

  10. Clinically relevant changes in potassium

    Part 1. Clinically relevant changes in potassium (mmol/L) after supplementation.

    Measured: Day 0 to 14

  11. Clinically relevant changes in chloride

    Part 1. Clinically relevant changes in chloride (mmol/L) after supplementation.

    Measured: Day 0 to 14

  12. 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.

    Measured: Day 0 to 14

  13. Clinically relevant changes in glucose

    Part 1. Clinically relevant changes in glucose (mmol/L) after supplementation.

    Measured: Day 0 to 14

  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

    Measured: Day 0 to 14

  15. Clinically relevant changes in white blood cell count

    Part 1. Clinically relevant changes in white blood cell count (x 10^9/L) after supplementation

    Measured: Day 0 to 14

  16. Clinically relevant changes in platelet count

    Part 1. Clinically relevant changes in platelet count (x 10^9/L) after supplementation

    Measured: Day 0 to 14

  17. Clinically relevant changes in hemoglobin

    Part 1. Clinically relevant changes in hemoglobin (g/L) after supplementation

    Measured: Day 0 to 14

  18. Clinically relevant changes in hematocrit

    Part 1. Clinically relevant changes in hematocrit (L/L) after supplementation

    Measured: Day 0 to 14

  19. Clinically relevant changes in red blood cell indices (MCV - Mean Corpuscular Volume)

    Part 1. Clinically relevant changes in MCV (fL) after supplementation

    Measured: Day 0 to 14

  20. Clinically relevant changes in red blood cell indices (MCH - Mean Corpuscular Hemoglobin)

    Part 1. Clinically relevant changes in MCH (pg) after supplementation

    Measured: Day 0 to 14

  21. Clinically relevant changes in red blood cell indices (MCHC - Mean Corpuscular Hemoglobin Concentration)

    Part 1. Clinically relevant changes in MCHC (g/L) after supplementation

    Measured: Day 0 to 14

  22. Clinically relevant changes in RDW - Red Cell Distribution Width

    Part 1. Clinically relevant changes in RDW (%) after supplementation

    Measured: Day 0 to 14

  23. Clinically relevant changes in red blood cell indices (MPV - Mean Platelet Volume)

    Part 1. Clinically relevant changes in MPV (fL) after supplementation

    Measured: Day 0 to 14

  24. 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.

    Measured: Visit 2 (day 1) to Visit 5 (day 22)

  25. 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.

    Measured: Visit 2 (day 1) to Visit 5 (day 22)

Secondary outcomes (4)

  1. 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

    Measured: Visit 2 (day 1) to Visit 5 (day 22)

  2. 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

    Measured: Visit 2 (day 1) to Visit 5 (day 22)

  3. 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

    Measured: Visit 2 (day 1) to Visit 5 (day 22)

  4. The difference in total calories consumed from the standardized meal between Lembas Edge an placebo

    Part 2. The difference in total calories consumed from the standardized meal provided on an ad libitum basis at time = 240 minutes between Lembas Edge (high dose, medium dose, low dose) and placebo

    Measured: Visit 2 (day 1) to Visit 5 (day 22), time = 240 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Part 1: Single-arm, open-label \& Part 2: Randomized, triple-blind, placebo controlled, cross over
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07711288
Sponsor's protocol ID
26LBKGR01
Status last verified
Sep 2026
First submitted
14 Jul 2026
Last updated
25 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Low dose alpha-galactosidase-derived peptide, Medium dose alpha-galactosidase-derived peptide and High dose alpha-galactosidase-derived peptide in people with Postprandial Glycemic Control and Prediabetic Overweight and Obese Adults, run by Lembas at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erin Lewis (+248 1-226-242-4551, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of post-emergent adverse events (AE) (time frame: Day 0 to 14). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07711288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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