Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control

Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877460
• Other study ID #: 26942
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: June 12, 2013
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: June 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Appetite Regulation
• Glucose Metabolism
• Health

Intervention

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.

Locations

Country	Name	City	State
Canada	Department of Nutritional Sciences, FitzGerald Building	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No