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

Обзор

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.
• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Incidence of post-emergent adverse events (AE) [Срок оценки: Day 0 to 14]
• Clinically relevant changes in blood pressure after supplementation [Срок оценки: Day 0 to 14]
• Clinically relevant changes in heart rate after supplementation [Срок оценки: Day 0 to 14]
• Clinically relevant changes in aspartate aminotransferase [Срок оценки: Day 0 to 14]
• Clinically relevant changes in alanine aminotransferase [Срок оценки: Day 0 to 14]
• Clinically relevant changes in alkaline phosphatase [Срок оценки: Day 0 to 14]
• Clinically relevant changes in total bilirubin [Срок оценки: Day 0 to 14]
• Clinically relevant changes in creatinine [Срок оценки: Day 0 to 14]
• Clinically relevant changes in sodium [Срок оценки: Day 0 to 14]
• Clinically relevant changes in potassium [Срок оценки: Day 0 to 14]

Вторичные конечные точки (3)

• The difference in postprandial glucose iAUC (0-240 min) between Lembas Edge and placebo [Срок оценки: Visit 2 (day 1) to Visit 5 (day 22)]
• The difference in postprandial insulin between Lembas Edge and placebo [Срок оценки: Visit 2 (day 1) to Visit 5 (day 22)]
• The difference in self-reported satiety scores between Lembas Edge and placebo [Срок оценки: Visit 2 (day 1) to Visit 5 (day 22)]

Критерии участия

Inclusion Criteria Part 1:

• 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)
• 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)

Inclusion Criteria Part 2:

• 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)

Exclusion Criteria Part 1:

• 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
• 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

Exclusion Criteria Part 2:

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• KGK Science Inc. — London

Идентификаторы

NCT: NCT07711288 · 26LBKGR01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗