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| Name | Class |
|---|---|
| National Dairy Council | OTHER |
| Dairy Management Inc. | INDUSTRY |
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The purpose of this study is to investigate the short-term effects of milk and yogurt of varying fat and protein content on cognitive performance in healthy children aged 9 - 14 years; and to provide insight into mechanisms by which dairy consumption may affect cognitive performance through gastrointestinal (GI) hormone responses. The investigators hypothesize that the consumption of dairy products, specifically their protein and fat components, will improve cognitive performance via its interaction with the gut-brain axis in children. Furthermore, the investigators hypothesize that all milk and yogurt products will enhance cognitive performance over 120- mins compared to snack skipping through its interaction with GI hormones, with a greater effect in higher fat containing milk and yogurt products.
A randomized within-subject repeated measures experiment will be used to study the effect of milk and yogurt of varying fat content on cognitive performance and its interaction with GI hormones in children (9-14 years). Participants will consume milk [Experiment A] and yogurt [Experiment B] test treatments, followed by measures of cognitive performance, blood glucose and GI hormone biomarkers over 120-min. In Experiment A and B, participants will consume, in a random order on separate mornings, one of four test treatments: (1) Full-fat, (2) Low-Fat, (3) No-fat, and (4) Snack-skipping test treatments. Cognitive domains (learning and memory, spatial working memory, attention, processing speed, and executive function), gastrointestinal hormone response, and subjective emotions will be assessed at baseline (0-min), and 30-, 60-, and 120-min following treatment consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat-Free Milk Treatment | Experimental | Test Treatment |
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| Low-Fat Milk Treatment | Experimental | Test Treatment |
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| Full-Fat Milk Treatment | Experimental | Test Treatment |
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| Snack Skipping Treatment | Experimental | Test Treatment |
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| Fat-Free Yogurt | Experimental | Test Treatment |
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| Low-Fat Yogurt | Experimental | Test Treatment |
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| Full-Fat Yogurt |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat-Free Milk | Other | Fat-free milk (500 mL, skim, 0%, Lactantia PurFiltre) will provide 180 kcal, 0.4 g fat, 26 g carbohydrate, and 18 g protein. Treatments matched for calories (180 kcal). |
| Measure | Description | Time Frame |
|---|---|---|
| Learning and short-term memory | Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Learning and short-term memory will be assessed using an immediate and delayed Word Recall Test (accuracy). | Immediate measured at 30-minutes post-treatment and delayed at 60- and 120-minutes post-treatment consumption |
| Spatial working memory | Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Spatial working memory will be assessed using the forward and backward versions of the Corsi Block Test (accuracy). | Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption |
| Sustained Attention | Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Sustained attention and processing speed will be assessed using the Continuous Performance Test (CPT) (accuracy). | Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption |
| Executive Function | Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Executive function and selective attention will be assessed using the Flanker Task (accuracy) | Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective mood and emotion | A visual analogue scale (VAS) with twelve questions will be administered to assess subjective emotions and mood (aggression, anger, excitement, disappointment, happiness, upset, frustration, alertness, sadness, tension, calmness, sleepiness, and wellness). Individual questions will be used to form a composite emotion score. Each VAS will be administered via a digital software application (Express VAS, Toronto, Ontario, Canada) on a Dell tablet where children will place an 'X" on the VAS line (100 unit scale) to describe their feelings. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nick Bellissimo, PhD | Toronto Metropolitan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Metropolitan University | Recruiting | Toronto | Ontario | M5B 2K3 | Canada |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Experimental |
Test Treatment |
|
| Low-Fat Milk | Other | Low-free milk (346 mL, 2%, Lactantia PurFiltre) will provide 180 kcal, 6.9 g fat, 16.6 g carbohydrate, and 12.5 g protein. Treatments matched for calories (180 kcal). |
|
| Full-fat Milk | Other | Full-free milk (281 mL, 3.25%, Lactantia PurFiltre) will provide 180 kcal, 9.0 g fat, 13.5 g carbohydrate, and 10.1 g protein. Treatments matched for calories (180 kcal). |
|
| Snack Skipping | Other | Snack skipping (no caloric contribution). |
|
| Fat-Free Yogurt | Other | Fat-free Yogurt (242.3 g, Oikos High Protein Vanilla; 0% MF) will provide 180 kcal, 0 g fat, 20.8 g carbohydrate, and 23.5 g protein. Treatments matched for calories (180 kcal). |
|
| Low-Fat Yogurt | Other | Low-fat Yogurt (210.0 g, Oikos Original 2% MF) will provide 180 kcal, 3.6 g fat, 21.6 g carbohydrate, and 15.6 g protein. Treatments matched for calories (180 kcal). |
|
| Full-Fat Yogurt | Other | Full-fat Yogurt (185.3 g, Oikos Extra Creamy Vanilla 9% MF) will provide 180 kcal, 15.9 g fat, 21.2 g carbohydrate, and 6.4 g protein. Treatments matched for calories (180 kcal). |
|
| Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption |
| Gastrointestinal Hormone Response | Blood biomarkers will include glucose, insulin, active GLP- 1, and total GIP. Blood samples will be collected via a venous catheter inserted into the participants arm by a Registered Nurse | Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |