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ObesityNCT02499107

The Effects of Carbohydrate Source on Food Intake, Blood Glucose and Gut Hormone Response in Healthy Children

A study testing Rice treatment, Pasta treatment and Boiled and mashed potato treatment in people with Obesity and Diabetes, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 11 to 13 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Diabetes
What is being tested?
Rice treatment, Pasta treatment and Boiled and mashed potato treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteCanada
Study dates
Apr 2013to Dec 2015
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 11 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • boys and girls
  • age 11 to 13 years old
  • healthy
  • BMI-for-age percentile 15% to 85%

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Department of Nutritional Sciences, FitzGerald Building

    Toronto, Ontario, M5S 3E2

Other trials in Canada

About this study

Official title: The Effects of Potatoes and Other Carbohydrate Side Dishes Consumed With Meat on Food Intake, Glycaemia and Satiety Response in Children

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.

Read the 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.

Conditions
Obesity, Diabetes
Being tested
Rice treatment, Pasta treatment, Boiled and mashed potato treatment, Baked french fries treatment, Fried french fries treatment
Keywords
food intake, satiety, blood glucose, potato, insulin
Medical subject headings
Obesity, Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rice treatmentDietary supplement

    All arms are given to all participants, in a randomized (cross over) order

  • Pasta treatmentDietary supplement

  • Boiled and mashed potato treatmentDietary supplement

  • Baked french fries treatmentDietary supplement

  • Fried french fries treatmentDietary supplement

Study groups in NCT02499107
Study groupRoleWhat they receive
Rice treatmentExperimentalDietary Intervention: Ad libitum intake of white rice
Receives: Dietary Supplement: Rice treatment
Pasta treatmentExperimentalDietary Intervention: Ad libitum intake of pasta
Receives: Dietary Supplement: Pasta treatment
boiled and mashed potato treatmentExperimentalDietary Intervention: Ad libitum intake of boiled and mashed potato
Receives: Dietary Supplement: Boiled and mashed potato treatment
Baked french fries treatmentExperimentalDietary Intervention: Ad libitum intake of baked french fries
Receives: Dietary Supplement: Baked french fries treatment
Fried french fries treatmentExperimentalDietary Intervention: Ad libitum intake of fried french fries
Receives: Dietary Supplement: Fried french fries treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Food intake will be measured at 30 min after ad libitum carbohydrate intake

Secondary outcomes (6)
  1. blood glucose

    Blood glucose (mmol/L) will be measured using finger prick capillary blood samples

    Measured: blood glucose will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.

  2. Plasma Insulin hormone

    Plasma Insulin hormone will be measured using intra-venous blood sample

    Measured: Insulin will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.

  3. Plasma Glucogan like peptide (GLP-1) hormone

    Plasma GLP-1 hormone will be measured using intra-venous blood sample

    Measured: GLP-1 will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.

  4. Plasma ghrelin hormone

    Plasma ghrelin hormone will be measured using intra-venous blood sample

    Measured: Active ghrelin hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.

  5. Peptide YY (PYY) hormone

    Plasma PYY hormone will be measured using intra-venous blood sample

    Measured: PYY hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.

  6. subjective appetite

    Subjective appetite will be measured by using visual analouge scales

    Measured: Subjective appetite will be measured at 0, 30, 45, 60, 75, 90 and 120 min - during the 2 hours study period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionAug 2015
  4. Study completionDec 2015

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02499107
Sponsor's protocol ID
APRE_29695
Status last verified
May 2017
First submitted
13 Jul 2015
Last updated
8 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Rice treatment, Pasta treatment and Boiled and mashed potato treatment in people with Obesity and Diabetes, 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 4 inclusion and 5 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 8 May 2017. 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?

Food Intake (time frame: Food intake will be measured at 30 min after ad libitum carbohydrate intake). 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 8 May 2017.

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