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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 grams of chia seeds | Placebo Comparator | 3 cookies (30 grams) |
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| 3 grams of chia seeds | Experimental | 3 cookies (30 grams) |
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| 5 grams of chia seeds | Experimental | 3 cookies (30 grams) |
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| 7 grams of chia seeds | Experimental | 3 cookies (30 grams) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 140 calories per 30 gram test meal | Other | Food |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas MS Wolever, MD, PhD | INQUIS Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INQUIS Clinical Research | Toronto | Ontario | M5C 2N8 | Canada |
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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 |