Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
G. Harvey Anderson, University of Toronto
ClinicalTrials.gov Identifier:
NCT01877460
First received: June 6, 2013
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Health
Appetite Regulation
Glucose Metabolism
Other: Dietary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effects of Isovolumetric Preloads of Sodium Alginate-enriched Chocolate Milk on Glycemia, Subjective Appetite and Food Intake in Healthy Young Men

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Food Intake [ Time Frame: 120 min ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

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


  • Serum Insulin Change [ Time Frame: 0, 30, 60, 120 (pre-meal), and 140, 170 and 200 min (post-meal) after consumption of treatments ] [ Designated as safety issue: No ]

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

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



Enrollment: 24
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877460

Locations
Canada, Ontario
Department of Nutritional Sciences, FitzGerald Building
Toronto, Ontario, Canada, M5S 3E2
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: G. Harvey Anderson, PhD University of Toronto
  More Information

No publications provided

Responsible Party: G. Harvey Anderson, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01877460     History of Changes
Other Study ID Numbers: 26942
Study First Received: June 6, 2013
Last Updated: June 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
sodium alginate
chocolate milk
satiety
energy intake
glycemia
insulinemia

Additional relevant MeSH terms:
Alginic acid
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014