Clinical trial NCT05345470: Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response
Official title: Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response: a Single Center, Randomized Cross-over Study in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Keywords: chia seeds
chia
Salvia hispanica L.
hunger
fullness
satiety
glycemic response
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 primary objective is to compare total area under the curves (tAUC) of hunger and fullness ratings. The hypothesis is that chia seeds have a significant effect on hunger and/or fullness.

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 fiber, low in available-carbohydrate (avCHO), and good sources of alpha-linoleic acid, protein, and micronutrients. Chia has attracted interest as a functional food with studies showing several potential beneficial effects on health, among them their ability to increase satiety and/or reduce food intake. The effect on satiety of doses of chia less than 7g is not known. The primary objective of this study is to compare total area under the curves (tAUC) of hunger and fullness ratings for 3h after consumption among test-meals containing 0, 3, 5 and 7g of chia seeds, controlling for energy intake.

Secondary objectives are tAUC of desire to eat and prospective consumption, tAUC of average appetite, tAUC of subjective appetite ratings from 0-2, 2-3 and 0-3h, Effects of time and dose and the time×dose interaction of plasma glucose concentrations and increments for 3h after consuming the test products, Incremental area under the curve (iAUC) of plasma glucose over 0-2h, 2-3h and 0-3h, and Plasma glucose peak rise.

Main effects of chia dose, time, and the dose×time interaction will be examined. After demonstrating a significant interaction, individual endpoints will be assessed for the main effect of dose. The significance of differences between doses will be assessed.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Total area under the curve (tAUC) of hunger ratings among test-meals containing 0, 3, 5 and 7 grams of chia seeds.
timeFrame: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
measure: Total area under the curve (tAUC) of fullness ratings among test-meals containing 0, 3, 5 and 7 grams of chia seeds.
timeFrame: Change from Time 0 -5 min(fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Secondary outcomes:
measure: Total area under the curve (tAUC) of desire to eat
timeFrame: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
measure: Total area under the curve (tAUC) of prospective consumption
timeFrame: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
measure: Total area under the curve (tAUC) of average appetite
timeFrame: Change from Time 0 -5 minutes (fasted) to 2, 2-3 and 0-3 hours
measure: Total area under the curve (tAUC) of subjective appetite ratings
timeFrame: Change from Time 0 -5 minutes (fasted) to 2, 2-3 and 0-3 hours
measure: Effects of time and dose and the time × dose interaction of plasma glucose concentrations and increments
timeFrame: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
measure: Incremental area under the curve (iAUC) of plasma glucose
timeFrame: Time 0 - 5 min (fasted) to 2, 2-3 and 0-3 hours after starting to eat
measure: Plasma glucose peak rise
timeFrame: Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: INQUIS Clinical Research
state: Ontario
Study officials:
affiliation: INQUIS Clinical Research
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: