NCT01877460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

6 months

First QC Date

June 6, 2013

Last Update Submit

June 12, 2013

Conditions

HealthAppetite RegulationGlucose Metabolism

Keywords

sodium alginatechocolate milksatietyenergy intakeglycemiainsulinemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Food Intake

    120 min

Other Outcomes (2)

  • Blood Glucose Change

    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

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

Study Arms (4)

Sodium alginate-free chocolate milk

EXPERIMENTAL

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

Other: Dietary intervention

1.25% sodium alginate chocolate milk

EXPERIMENTAL

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

Other: Dietary intervention

2.5% sodium alginate chocolate milk

EXPERIMENTAL

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

Other: Dietary intervention

2.5% sodium alginate milk-free water-based solution

EXPERIMENTAL

Water solution with 2.5% sodium alginate

Other: Dietary intervention

Interventions

Dietary interventionOTHER

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 milk2.5% sodium alginate chocolate milk2.5% sodium alginate milk-free water-based solutionSodium alginate-free chocolate milk

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy,
  • non-smoking male subjects,
  • aged 20-30 years with a body mass index between 20 and 24.9 kg/m2, were recruited.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences, FitzGerald Building

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • G. Harvey Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 13, 2013

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

CA(1)