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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nutrition, Healthy

Intervention / Treatment
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* Other: 140 calories per 30 gram test meal


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0 grams of chia seeds<br>3 cookies (30 grams) | Other: 140 calories per 30 gram test meal<br>* Food<br>|
| Experimental: 3 grams of chia seeds<br>3 cookies (30 grams) | Other: 140 calories per 30 gram test meal<br>* Food<br>|
| Experimental: 5 grams of chia seeds<br>3 cookies (30 grams) | Other: 140 calories per 30 gram test meal<br>* Food<br>|
| Experimental: 7 grams of chia seeds<br>3 cookies (30 grams) | Other: 140 calories per 30 gram test meal<br>* Food<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chia seeds, chia, Salvia hispanica L., hunger, fullness, satiety, glycemic response