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.
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
- 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
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.
- 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 group | Role | What they receive |
|---|---|---|
| Rice treatment | Experimental | Dietary Intervention: Ad libitum intake of white rice Receives: Dietary Supplement: Rice treatment |
| Pasta treatment | Experimental | Dietary Intervention: Ad libitum intake of pasta Receives: Dietary Supplement: Pasta treatment |
| boiled and mashed potato treatment | Experimental | Dietary Intervention: Ad libitum intake of boiled and mashed potato Receives: Dietary Supplement: Boiled and mashed potato treatment |
| Baked french fries treatment | Experimental | Dietary Intervention: Ad libitum intake of baked french fries Receives: Dietary Supplement: Baked french fries treatment |
| Fried french fries treatment | Experimental | Dietary 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.
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)
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.
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.
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.
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.
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.
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.
- First posted15 Jul 2015 (estimated)
- Study startApr 2013
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 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
- Harvey G Anderson, PhD, Principal investigator, University of Toronto
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Potatoes and Other Carbohydrate Side Dishes Consumed With Meat on Food Intake, Glycaemia and Satiety Response in Children
- ClinicalTrials.gov ID
- NCT02499107
- Acronym / sponsor ID
- APRE_29695
- Keywords
- food intake, satiety, blood glucose, potato, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jul 2015 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Rice treatment | Experimental | Dietary Supplement: Rice treatmentDietary Intervention: Ad libitum intake of white rice |
| Pasta treatment | Experimental | Dietary Supplement: Pasta treatmentDietary Intervention: Ad libitum intake of pasta |
| boiled and mashed potato treatment | Experimental | Dietary Supplement: Boiled and mashed potato treatmentDietary Intervention: Ad libitum intake of boiled and mashed potato |
| Baked french fries treatment | Experimental | Dietary Supplement: Baked french fries treatmentDietary Intervention: Ad libitum intake of baked french fries |
| Fried french fries treatment | Experimental | Dietary Supplement: Fried french fries treatmentDietary Intervention: Ad libitum intake of fried french fries |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- boys and girls
- age 11 to 13 years old
- healthy
- BMI-for-age percentile 15% to 85%
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Rice treatmentAll arms are given to all participants, in a randomized (cross over) order | Dietary supplement | Rice treatment |
| Pasta treatment | Dietary supplement | Pasta treatment |
| Boiled and mashed potato treatment | Dietary supplement | boiled and mashed potato treatment |
| Baked french fries treatment | Dietary supplement | Baked french fries treatment |
| Fried french fries treatment | Dietary supplement | Fried french fries treatment |
Primary outcome
Food Intake
Time frame: Food intake will be measured at 30 min after ad libitum carbohydrate 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.
6 secondary outcomes
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.
Plasma Insulin hormone
Time frame: Insulin will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
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.
Plasma ghrelin hormone
Time frame: Active ghrelin hormone will be measured at 0, 30, 60 and 120 min - during the 2 hours study period.
Peptide YY (PYY) hormone
Time frame: 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.
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 8 May 2017.
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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.
Harvey G 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 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.