Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control

Study Overview
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Brief Summary
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This study compares the effects of isovolumetric (325 ml) preloads of chocolate milk supplemented with sodium alginates at incremental doses on inter-meal glucose levels, appetite scores and food intake in healthy adult men. The findings of this study will illustrate whether the addition of sodium alginate to chocolate milk will improve the glycemic properties of chocolate milk and will potentiate its satiating characteristics. This study will also elucidate whether sodium alginates, incorporated into chocolate milk, will influence glycemia, appetite sensations and food intake in a dose-dependent manner. It is hypothesized that there will be a synergy between milk and sodium alginate beyond either alone. When combined with milk components, sodium alginate is expected to improve glycemia and induce satiety more than does either milk alone or alginate alone.

Official Title
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The Effects of Isovolumetric Preloads of Sodium Alginate-enriched Chocolate Milk on Glycemia, Subjective Appetite and Food Intake in Healthy Young Men

Conditions
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Health, Appetite Regulation, Glucose Metabolism

Intervention / Treatment
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* Other: Dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking male subjects, aged 20-30 years with a body mass index between 20 and 24.9 kg/m2, were recruited. Exclusion Criteria: Breakfast skippers, smokers, dieters, individuals with lactose-intolerance or who are allergic to milk, individuals with gastrointestinal problems and individuals with diabetes or other metabolic diseases were excluded from the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium alginate-free chocolate milk<br>Sodium alginate-free chocolate milk (1% fat) (Beatrice Ltd., Toronto, Ontario) | Other: Dietary intervention<br>* All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.<br>|
| Experimental: 1.25% sodium alginate chocolate milk<br>Chocolate milk (Beatrice Ltd., Toronto, Ontario) with 1.25% sodium alginate | Other: Dietary intervention<br>* All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.<br>|
| Experimental: 2.5% sodium alginate chocolate milk<br>Chocolate milk (Beatrice Ltd., Toronto, Ontario) with 2.5% sodium alginate | Other: Dietary intervention<br>* All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.<br>|
| Experimental: 2.5% sodium alginate milk-free water-based solution<br>Water solution with 2.5% sodium alginate | Other: Dietary intervention<br>* All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety Change | Pre-meal changes from 0 min; Post-meal changes from 120 min Satiety scores (mm) were assessed using 100-mm Motivation to Eat visual analog scale questionnaires. A composite score of the four appetite questions, including Desire to Eat, Hunger, Fullness and Prospective Food Consumption, in the Motivation to Eat visual analog scale was calculated to obtain the average appetite score for statistical analysis. | 0, 10, 20, 30, 45, 60, 75, 90 and 120 min (pre-meal) and 140, 170, 200, 230 and 260 min (post-meal) after consumption of the treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Intake | Food intake (kCal) was assessed 120 min after consumption of the treatments, using an ad libitum pizza lunch meal. Participants were asked to eat, during a 20-min period, until feeling comfortably full. | 120 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sodium alginate, chocolate milk, satiety, energy intake, glycemia, insulinemia