Dietary Supplementation on Body Fat Composition

Exclusion Criteria

• •1. Weight loss or gain ≥4.5 kg within 90 days of visit 1.
• •2. Use of weight loss medications within 90 days of visit 1
• •3. History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
• •4. Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1.
• •5. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
• •6. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
• •7. Current medical diagnosis of type 1 or type 2 diabetes mellitus.
• •8. HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1.
• •9. History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
• •10. History of liver disease with exception of non-alcoholic fatty livery disease (NAFLD).
• •11. Unstable use of medications for mental or emotional disorders, where stable use is defined as the same dose for ≥90 days prior to visit 1.
• •12. Uncontrolled stage 2 hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1. Participants with hypertension on a stable dose of medication may be allowed in the study per Investigator's discretion. Stable dose is defined as same dose for \>90 days.
• •13. Habitual use (i.e., daily) of marijuana and hemp products including CBD products within 30 days of visit 1.
• •14. History or presence of cancer (including any malignant GI polyps) within 2 years of visit 1, except for non-melanoma skin cancer.
• •15. Unstable use of thyroid hormone replacement medication, where stable use is defined as the same dose for ≥90 days prior to visit 1.
• •16. Known intolerance or sensitivity to any ingredients in the study products.
• •17. Exposure to any non-registered drug product within 4 weeks prior to visit 1.
• •18. Signs or symptoms of an active infection of clinical relevance\* within 5 days of visit 1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1.
• •19. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
• •20. Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1½ oz. distilled spirits).
• •21. Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk. \*If an infection occurs during the study period, test visits will be rescheduled until signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to the scheduled study visits.