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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02499107
Other study ID # APRE_29695
Secondary ID
Status Completed
Phase N/A
First received July 13, 2015
Last updated May 4, 2017
Start date April 2013
Est. completion date December 2015

Study information

Verified date May 2017
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the 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. Healthy boys and girls, aged between 11 - 13 years old, will be involved in this study.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date December 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 13 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Rice treatment
All arms are given to all participants, in a randomized (cross over) order
Pasta treatment

Boiled and mashed potato treatment

Baked french fries treatment

Fried french fries treatment


Locations

Country Name City State
Canada Department of Nutritional Sciences, FitzGerald Building Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Food Intake 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. Food intake will be measured at 30 min after ad libitum carbohydrate intake
Secondary blood glucose Blood glucose (mmol/L) will be measured using finger prick capillary blood samples blood glucose will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.
Secondary Plasma Insulin hormone Plasma Insulin hormone will be measured using intra-venous blood sample Insulin will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
Secondary Plasma Glucogan like peptide (GLP-1) hormone Plasma GLP-1 hormone will be measured using intra-venous blood sample GLP-1 will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
Secondary Plasma ghrelin hormone Plasma ghrelin hormone will be measured using intra-venous blood sample Active ghrelin hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
Secondary Peptide YY (PYY) hormone Plasma PYY hormone will be measured using intra-venous blood sample PYY hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
Secondary subjective appetite Subjective appetite will be measured by using visual analouge scales 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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