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

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.

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