Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response

NCT ID: NCT05345470

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-17
• Study Completion Date: 2022-06-24

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.

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

0 grams of chia seeds

3 cookies (30 grams)

Group Type: PLACEBO_COMPARATOR

140 calories per 30 gram test meal

Intervention Type: OTHER

Food

3 grams of chia seeds

3 cookies (30 grams)

Group Type: EXPERIMENTAL

140 calories per 30 gram test meal

Intervention Type: OTHER

Food

5 grams of chia seeds

3 cookies (30 grams)

Group Type: EXPERIMENTAL

140 calories per 30 gram test meal

Intervention Type: OTHER

Food

7 grams of chia seeds

3 cookies (30 grams)

Group Type: EXPERIMENTAL

140 calories per 30 gram test meal

Intervention Type: OTHER

Food

Interventions

140 calories per 30 gram test meal

Food

Intervention Type: OTHER

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

• 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)

Exclusion Criteria

• Participation in another PepsiCo trial in past 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas MS Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

INQUIS Clinical Research

Locations

INQUIS Clinical Research

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

PEP-2117

Identifier Type: -

Identifier Source: org_study_id