| Eligibility |
Inclusion Criteria:
- Individuals, 20-70 years of age, inclusive.
- Body mass index (BMI) between 18 and 33 kg/m², inclusive, at screening.
- Willing to maintain habitual diet, physical activity pattern, and body weight
throughout the trial.
- Willing to maintain current dietary supplement and non exclusionary medication use
throughout the trial.
- Willing to avoid the consumption of alcohol, unusual food intake, unusual physical
activity and consumption of any flatulence promoting foods 24h prior to each study
visit. Failure to follow will result in rescheduled visit.
- Understanding the study procedures and willing to provide informed consent to
participate in the study and authorization to release relevant protected. health
information to the study investigator.
Exclusion Criteria:
- Failure to meet any one of the inclusion criteria.
- Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease,
coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of
clinically important endocrine (including Type 1 or Type 2 diabetes mellitus),
cardiovascular (including, but not limited to, atherosclerotic disease, history of
myocardial infarction, peripheral arterial disease, stroke), pulmonary, or biliary
diseases, or any condition which might, in the opinion of the medical director either:
1) make participation dangerous to the subject or to others, or 2) affect the results.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal
function or appetite, including, but not limited to adrenergic blockers, diuretics,
thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the
screening visit, or any medication which might, in the opinion of the medical director
either: 1) make participation dangerous to the subject or to others, or 2) affect the
results.
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow
INQUIS health and safety policies.
- Known intolerance, sensitivity or allergy to test foods.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high
protein diets, etc.).
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Exposure to any non-registered drug product within 30 d prior to screening.
- Self reported pregnancy or breastfeeding.
- Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge
eating) diagnosed by a health professional.
|
