HealthNCT01877460
Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control
A study testing Dietary intervention in people with Health and Appetite Regulation, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health, Appetite Regulation, Glucose Metabolism
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy,
- non-smoking male subjects,
- aged 20-30 years with a body mass index between 20 and 24.9 kg/m2, were recruited.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Nutritional Sciences, FitzGerald Building
Toronto, Ontario, M5S 3E2
About this study
Official title: 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.
- Conditions
- Health, Appetite Regulation, Glucose Metabolism
- Being tested
- Dietary intervention
- Keywords
- sodium alginate, chocolate milk, satiety, energy intake, glycemia, insulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.
| Study group | Role | What they receive |
|---|---|---|
| Sodium alginate-free chocolate milk | Experimental | Sodium alginate-free chocolate milk (1% fat) (Beatrice Ltd., Toronto, Ontario) Receives: Other: Dietary intervention |
| 1.25% sodium alginate chocolate milk | Experimental | Chocolate milk (Beatrice Ltd., Toronto, Ontario) with 1.25% sodium alginate Receives: Other: Dietary intervention |
| 2.5% sodium alginate chocolate milk | Experimental | Chocolate milk (Beatrice Ltd., Toronto, Ontario) with 2.5% sodium alginate Receives: Other: Dietary intervention |
| 2.5% sodium alginate milk-free water-based solution | Experimental | Water solution with 2.5% sodium alginate Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G. Harvey Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877460
- Sponsor's protocol ID
- 26942
- Status last verified
- Jun 2013
- First submitted
- 6 Jun 2013
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Isovolumetric Preloads of Sodium Alginate-enriched Chocolate Milk on Glycemia, Subjective Appetite and Food Intake in Healthy Young Men
- ClinicalTrials.gov ID
- NCT01877460
- Acronym / sponsor ID
- 26942
- Conditions
- Health, Appetite Regulation, Glucose Metabolism
- Keywords
- sodium alginate, chocolate milk, satiety, energy intake, glycemia, insulinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sodium alginate-free chocolate milk | Experimental | Other: Dietary interventionSodium alginate-free chocolate milk (1% fat) (Beatrice Ltd., Toronto, Ontario) |
| 1.25% sodium alginate chocolate milk | Experimental | Other: Dietary interventionChocolate milk (Beatrice Ltd., Toronto, Ontario) with 1.25% sodium alginate |
| 2.5% sodium alginate chocolate milk | Experimental | Other: Dietary interventionChocolate milk (Beatrice Ltd., Toronto, Ontario) with 2.5% sodium alginate |
| 2.5% sodium alginate milk-free water-based solution | Experimental | Other: Dietary interventionWater solution with 2.5% sodium alginate |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy,
- non-smoking male subjects,
- aged 20-30 years with a body mass index between 20 and 24.9 kg/m2, were recruited.
Key exclusion criteria (7 listed)
- Breakfast skippers,
- smokers,
- dieters,
- individuals with lactose-intolerance or
- who are allergic to milk,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionAll arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting. | Other | 1.25% sodium alginate chocolate milk, 2.5% sodium alginate chocolate milk, 2.5% sodium alginate milk-free water-based solution, Sodium alginate-free chocolate milk |
Primary outcome
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.
1 secondary outcome
Food Intake
Time frame: 120 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Harvey Anderson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Health and Appetite Regulation, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.