Status:
COMPLETED
Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response
Lead Sponsor:
PepsiCo Global R&D
Conditions:
Nutrition, Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To compare subjective appetite, satiety and glycemic responses for 3 h after consumption of investigational products containing 0, 3, 5 and 7 grams of chia seeds, controlling for energy intake. The pr...
Detailed Description
Current nutrition guidelines in the United States and Canada recommend meeting protein needs with nutrient-dense foods among which include legumes, nuts, and seeds. Chia seeds are very high in dietary...
Eligibility Criteria
Inclusion
- Non-pregnant, non-lactating, healthy individuals; at least n=45 aged 18-55 years and up to n=5 aged 56-65 years, inclusive
- BMI 18.5 to 34.9 kg/m², inclusive
- No history of diabetes mellitus
- Systolic blood pressure \<160 mmHg and diastolic blood pressure \<100 mmHg
- No major illness, trauma or surgery requiring hospitalization within 3 months of the screening visit
- Ability to understand the study procedures and willing to provide informed consent to participate in the study
- Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
- Subjects are willing to follow current Covid guidelines with respect to attending study visits
- Subjects are willing to sign the informed consent prior to any procedures conducted
Exclusion
- Participation in another PepsiCo trial in past 6 months
- Failure to meet any one of the inclusion criteria
- High alcohol consumption (\>14 drinks per week and \>4 drinks per day for males; and \>7 drinks per week and \>3 drinks per day for females), or history of alcohol or drug abuse.
- Individuals with a history of bariatric surgery, gastrointestinal disease, moderate or severe renal failure, moderate or severe liver disease or any other medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
- Known intolerance, sensitivity, or allergy to any ingredients in the study test products.
- Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification.
- Reported weight change of \> 5kg in the preceding 3 months
- History of an eating disorder (e.g., anorexia, bulimia, binge eating, pica, rumination, avoidant/restrictive food intake disorder)
Key Trial Info
Start Date :
March 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05345470
Start Date
March 17 2022
End Date
June 24 2022
Last Update
July 8 2022
Active Locations (1)
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1
INQUIS Clinical Research
Toronto, Ontario, Canada, M5C 2N8