Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control

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

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.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism; Appetite Regulation; Health
• Intervention / Treatment: Other: Dietary intervention

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 3E2
      • Department of Nutritional Sciences, FitzGerald Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Glucose Change	Pre-meal changes from 0 min; Post-meal changes from 120 min Blood glucose (mmol/L) was measured using finger prick capillary blood sample.	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
Serum Insulin Change	Pre-meal changes from 0 min; Post-meal changes from 120 min Serum insulin (μU/mL) was measured using finger prick capillary blood sample.	0, 30, 60, 120 (pre-meal), and 140, 170 and 200 min (post-meal) after consumption of treatments

Collaborators and Investigators

• Sponsor: University of Toronto

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 13, 2013

Study Record Updates

• Last Update Posted (Estimate): June 13, 2013
• Last Update Submitted That Met QC Criteria: June 12, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: energy intake; satiety; glycemia; sodium alginate; chocolate milk; insulinemia
• Other Study ID Numbers: 26942