Clinical trial NCT02499107: The Effects of Carbohydrate Source on Food Intake, Blood Glucose and Gut Hormone Response in Healthy Children
Official title: The Effects of Potatoes and Other Carbohydrate Side Dishes Consumed With Meat on Food Intake, Glycaemia and Satiety Response in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Keywords: food intake
satiety
blood glucose
potato
insulin
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 32
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Food Intake
timeFrame: Food intake will be measured at 30 min after ad libitum carbohydrate intake
Secondary outcomes:
measure: blood glucose
timeFrame: blood glucose will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.
measure: Plasma Insulin hormone
timeFrame: Insulin will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
measure: Plasma Glucogan like peptide (GLP-1) hormone
timeFrame: GLP-1 will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
measure: Plasma ghrelin hormone
timeFrame: Active ghrelin hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
measure: Peptide YY (PYY) hormone
timeFrame: PYY hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
measure: subjective appetite
timeFrame: Subjective appetite will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences, FitzGerald Building
state: Ontario
Study officials:
affiliation: University of Toronto, Toronto
name: Harvey G Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: