Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control

NCT ID: NCT01877460

Last Updated: 2013-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-07-31

Brief Summary

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.

Conditions

Health; Appetite Regulation; Glucose Metabolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Sodium alginate-free chocolate milk

Sodium alginate-free chocolate milk (1% fat) (Beatrice Ltd., Toronto, Ontario)

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.

1.25% sodium alginate chocolate milk

Chocolate milk (Beatrice Ltd., Toronto, Ontario) with 1.25% sodium alginate

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.

2.5% sodium alginate chocolate milk

Chocolate milk (Beatrice Ltd., Toronto, Ontario) with 2.5% sodium alginate

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.

2.5% sodium alginate milk-free water-based solution

Water solution with 2.5% sodium alginate

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.

Interventions

Dietary intervention

All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

G. Harvey Anderson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

G. Harvey Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Department of Nutritional Sciences, FitzGerald Building

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

26942

Identifier Type: -

Identifier Source: org_study_id