- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02499107
The Effects of Carbohydrate Source on Food Intake, Blood Glucose and Gut Hormone Response in Healthy Children
The Effects of Potatoes and Other Carbohydrate Side Dishes Consumed With Meat on Food Intake, Glycaemia and Satiety Response in Children
Study Overview
Status
Detailed Description
The prevalence of childhood obesity and overweight has become a major health concern worldwide. Prevention of overweight and obesity in children is a high priority because they are at high risk of becoming obese adults and obesity is predictive of the development of coronary heart disease, hypertension and diabetes. Thus, there is a need for food-based solutions to increase satiety and subsequently reduce energy intake.
Over the past 40 years, the consumption of potatoes has decreased by 41% which may be a consequence of movements aimed at decreasing serving sizes, or the outright banning, of potato foods from cafeterias and quick service restaurants such as French fries due to the observational studies showing they are linked with increased risk of obesity. Alternate energy dense starches such as rice and pasta have increased in consumption as a result for meal accompaniments with no discernible decrease in the upward trajectory of the number of overweight and obese individuals. These recent trends may be a consequence of individuals ignoring vital information such as the substantial nutrient content as well as the overall balance and low energy density to nutrient density ratio of the potato in addition to other beneficial components.
Compounding this, research has also indicated that the GI of potatoes is high relative to other starches, in spite of recent evidence suggesting a high variability in these measurements or little consideration taken for the preparation method of the potato (potato chips vs. baked potato, for example). Additionally, potatoes are commonly consumed with other foods which in turn often significantly lower the GI of the meal when compared to consumption of the potato alone. For example, Estima potatoes ingested with 62 g of cheddar cheese reduced the GI from 93 to 39 and mashed potatoes served with oil, chicken breast and salad (representing a meal) reduced the GI of the potato from 108 to 54. The GI is based on the consumption of a fixed amount of available carbohydrate, which may not be representative of the glycaemic effect of the amount of carbohydrate usually consumed in a serving of a food within a meal, such as the case with potatoes.
We have extensive experience in conducting experimental studies especially with children. Previously in our laboratory, we investigated and published numerous studies focused on assessing food intake (FI) regulation and appetite in children aged 9 to 13 years.
Thus, the purpose of the current study is to determine effects of commonly consumed carbohydrate sources such as potatoes, pasta and rice along with a fixed portion of meat on blood glucose, satiety and insulin levels among healthy body weight children (aged 11 to 13 years) over a 2 hour period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5S 3E2
- Department of Nutritional Sciences, FitzGerald Building
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- boys and girls
- age 11 to 13 years old
- healthy
- BMI-for-age percentile 15% to 85%
Exclusion Criteria:
- taking any medications,
- Parental report of children with major disease,
- behavioral or emotional difficulties,
- children who have a food allergy,
- children follow a therapeutic diet, or do not habitually eat breakfast
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rice treatment
Dietary Intervention: Ad libitum intake of white rice
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All arms are given to all participants, in a randomized (cross over) order
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Experimental: Pasta treatment
Dietary Intervention: Ad libitum intake of pasta
|
|
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Experimental: boiled and mashed potato treatment
Dietary Intervention: Ad libitum intake of boiled and mashed potato
|
|
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Experimental: Baked french fries treatment
Dietary Intervention: Ad libitum intake of baked french fries
|
|
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Experimental: Fried french fries treatment
Dietary Intervention: Ad libitum intake of fried french fries
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food Intake
Time Frame: Food intake will be measured at 30 min after ad libitum carbohydrate intake
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Food intake (kCal) will be assessed 30 min after consumption of the ad libitum treatments of either rice, pasta, boiled and mashed potatoes, baked french fries or fried french fries.
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Food intake will be measured at 30 min after ad libitum carbohydrate intake
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood glucose
Time Frame: blood glucose will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.
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Blood glucose (mmol/L) will be measured using finger prick capillary blood samples
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blood glucose will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.
|
|
Plasma Insulin hormone
Time Frame: Insulin will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
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Plasma Insulin hormone will be measured using intra-venous blood sample
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Insulin will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
|
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Plasma Glucogan like peptide (GLP-1) hormone
Time Frame: GLP-1 will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
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Plasma GLP-1 hormone will be measured using intra-venous blood sample
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GLP-1 will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
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Plasma ghrelin hormone
Time Frame: Active ghrelin hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
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Plasma ghrelin hormone will be measured using intra-venous blood sample
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Active ghrelin hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
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Peptide YY (PYY) hormone
Time Frame: PYY hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
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Plasma PYY hormone will be measured using intra-venous blood sample
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PYY hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
|
|
subjective appetite
Time Frame: Subjective appetite will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.
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Subjective appetite will be measured by using visual analouge scales
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Subjective appetite will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harvey G Anderson, PhD, University of Toronto, Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- APRE_29695
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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