Skip to main content
OpenTrials
Completed

NCT Number: NCT01877460

Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Health Appetite Regulation Glucose Metabolism

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutritional Sciences, FitzGerald Building

Toronto, Ontario, M5S 3E2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Intervention

Other

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

Primary outcomes

  1. Satiety Change

    Time frame: 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

    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.

Secondary outcomes

  1. Food Intake

    Time frame: 120 min

    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.

Other outcomes

  1. Blood Glucose Change

    Time frame: 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

    Pre-meal changes from 0 min; Post-meal changes from 120 min

    Blood glucose (mmol/L) was measured using finger prick capillary blood sample.

  2. Serum Insulin Change

    Time frame: 0, 30, 60, 120 (pre-meal), and 140, 170 and 200 min (post-meal) after consumption of treatments

    Pre-meal changes from 0 min; Post-meal changes from 120 min

    Serum insulin (μU/mL) was measured using finger prick capillary blood sample.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2013
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.