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

Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response: a Single Center, Randomized Cross-over Study in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Other: 140 calories per 30 gram test meal

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • INQUIS Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 0 grams of chia seeds; 3 cookies (30 grams)	Other: 140 calories per 30 gram test meal; Food
EXPERIMENTAL: 3 grams of chia seeds; 3 cookies (30 grams)	Other: 140 calories per 30 gram test meal; Food
EXPERIMENTAL: 5 grams of chia seeds; 3 cookies (30 grams)	Other: 140 calories per 30 gram test meal; Food
EXPERIMENTAL: 7 grams of chia seeds; 3 cookies (30 grams)	Other: 140 calories per 30 gram test meal; Food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total area under the curve (tAUC) of hunger ratings among test-meals containing 0, 3, 5 and 7 grams of chia seeds.	Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on 100 mm line from 0=Not very hungry at all to 100= As hungry as I have ever felt	Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Total area under the curve (tAUC) of fullness ratings among test-meals containing 0, 3, 5 and 7 grams of chia seeds.	Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on 100 mm line from 0=Not full at all to 100=As full as I have ever felt	Change from Time 0 -5 min(fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total area under the curve (tAUC) of desire to eat	Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on 100 mm line from 0=Very weak to 100=Very strong	Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Total area under the curve (tAUC) of prospective consumption	Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on100 mm line from 0=Nothing at all to 100= A large amount	Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Total area under the curve (tAUC) of average appetite	Average Appetite will be calculated as (Desire to Eat + Hunger + (100-Fullness) + Prospective consumption)/4	Change from Time 0 -5 minutes (fasted) to 2, 2-3 and 0-3 hours
Total area under the curve (tAUC) of subjective appetite ratings	Measured using the Motivation to eat Visual Analog Scale (VAS) which consists of 4 questions assessing Desire to Eat, Hunger, Fullness, and Prospective Consumption	Change from Time 0 -5 minutes (fasted) to 2, 2-3 and 0-3 hours
Effects of time and dose and the time × dose interaction of plasma glucose concentrations and increments	Main effects assessed using ANOVA. Differences between doses assessed using Tukey's test to adjust for multiple comparisons.	Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Incremental area under the curve (iAUC) of plasma glucose	Capillary blood via finger sticks centrifuged. Plasma glucose analyzed using a Vitros 350 Chemistry System	Time 0 - 5 min (fasted) to 2, 2-3 and 0-3 hours after starting to eat
Plasma glucose peak rise	The maximum glucose value	Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Thomas MS Wolever, MD, PhD, INQUIS Clinical Research Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2022
• Primary Completion (ACTUAL): June 24, 2022
• Study Completion (ACTUAL): June 24, 2022

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (ACTUAL): April 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: satiety; hunger; glycemic response; chia seeds; chia; Salvia hispanica L.; fullness
• Other Study ID Numbers: PEP-2117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No