HealthyNCT03307681
Effect of White Potatoes on Glycemic Response, Satiety and Food Intake in Children
A study testing White bread, Baked potato with skin and Mashed potato served hot in people with Healthy, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The purpose of the present study is to explore the influence of cooking methods on post-prandial glycaemia and its impact on satiety in children. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- White bread, Baked potato with skin and Mashed potato served hot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 21 Dec 2018to 21 Jun 2020
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be between 9 and 14 years of age
- be healthy, and have been born at term
- be a native English speaker
- not be taking any medications
- not have allergies to potatoes, rice, or beans.
- normal body weight (between the 5th and 85th BMI percentile for age and gender)
Who cannot join
- anyone with food sensitivities or allergies to potatoes or potato-products,
- smokers
- diabetic or overweight/obese individuals.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the present study is to explore the influence of cooking methods on post-prandial glycaemia and its impact on satiety in children.
Read the detailed description
Each of the 5 study sessions will be at least 7 days apart. Either meal skipping, or one of three treatments of white potatoes (a) baked (with skin), (b) mashed, (c) fried French fries, or white bread, prepared on the day of testing, will be served to healthy children (9-14 years). Participants will consume the equivalent to 1 medium sized potato (~280 kcal) or an equivalent amount of calories from white bread. Glycemic response, insulin, incretin hormones (glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP)), dipeptidyl peptidase 4 (DPP4), and cholecystokinin (CCK) will be measured for 2 h (0, 15, 30, 45, 60, 90 and 120 min) following meal consumption, as well as mood and subjective appetite. An ad libitum test meal will be provided at 120 min to assess food intake suppression.
- Conditions
- Healthy
- Being tested
- White bread, Baked potato with skin, Mashed potato served hot, Fried French fries, Meal skipping
- Keywords
- White potatoes, Children, Satiety, Glycaemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White breadOther
Toasted, with canola oil added to match for fat content of French fries (13.9 grams), as well as being matched for energy (280 kilocalories) and available carbohydrate content (33 grams) of potato treatments.
Baked potato with skinOther
Baked russet potato with canola oil added once baked to match for fat content of French fries, and also matched for the salt content of white bread (280 milligrams).
Mashed potato served hotOther
Mashed potatoes prepared from frozen, with canola oil added to match for fat content of French fries, as well as being matched for energy and available carbohydrate content of the baked potato.
Fried French friesOther
Prepared from frozen, matched for energy and available carbohydrate content of baked potato and salt content of white bread.
Meal skippingOther
No food given
| Study group | Role | What they receive |
|---|---|---|
| White bread | Experimental | Matched for energy content and available carbohydrate content of potato treatments Receives: Other: White bread |
| Baked potato with skin | Experimental | Baked russet potato Receives: Other: Baked potato with skin |
| Mashed potato served hot | Experimental | Mashed potatoes prepared from frozen, matched for available carbohydrate content of baked potato Receives: Other: Mashed potato served hot |
| Fried French fries | Experimental | Matched for available carbohydrate content of baked potato Receives: Other: Fried French fries |
| Meal skipping | Experimental | No food given Receives: Other: Meal skipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum food intake (lunch, at 120 minutes)
Food intake will be determined by weighing the meal before and after serving. The net weight of the test meal will be converted to calories
Measured: at 120 minutes post morning meal consumption
Change from baseline glycemic response
Blood glucose (mmol/L). Blood glucose will be measured in whole blood using YSI 2300 STAT PLUS (YSI Incorporated, Yellow Springs, OH)
Measured: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline insulin
Blood insulin (pmol/L). Insulin concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
Measured: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Secondary outcomes (6)
Change from baseline subjective appetite
Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.
Measured: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline mood
Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.
Measured: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline cholecystokinin (CCK)
Blood CCK (pmol/L). CCK concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
Measured: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline dipeptidyl peptidase 4 (DPP4)
Blood DPP4 (ng/mL). DPP4 concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
Measured: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline glucose-dependent insulinotropic peptide (GIP)
Blood GIP (pmol/L). GIP concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
Measured: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline glucagon-like peptide-1 (GLP-1)
Blood GLP-1 (pmol/L). GLP-1 concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
Measured: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start21 Dec 2018
- Primary completion21 Jun 2020
- Study completion21 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Bellissimo, Toronto Metropolitan University
- Investigators
- Nick Bellissimo, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307681
- Sponsor's protocol ID
- REB2017-330 II
- Status last verified
- Mar 2020
- First submitted
- 29 Sep 2017
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of White Potatoes on Glycemic Response, Satiety and Food Intake in Children
- ClinicalTrials.gov ID
- NCT03307681
- Acronym / sponsor ID
- REB2017-330 II
- Conditions
- Healthy
- Keywords
- White potatoes, Children, Satiety, Glycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 21 Jun 2020 (actual)
- Study completion
- 21 Jun 2020 (actual)
- First posted
- 12 Oct 2017 (actual)
- 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.
The purpose of the present study is to explore the influence of cooking methods on post-prandial glycaemia and its impact on satiety in children.
Detailed description
Each of the 5 study sessions will be at least 7 days apart. Either meal skipping, or one of three treatments of white potatoes (a) baked (with skin), (b) mashed, (c) fried French fries, or white bread, prepared on the day of testing, will be served to healthy children (9-14 years). Participants will consume the equivalent to 1 medium sized potato (~280 kcal) or an equivalent amount of calories from white bread. Glycemic response, insulin, incretin hormones (glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP)), dipeptidyl peptidase 4 (DPP4), and cholecystokinin (CCK) will be measured for 2 h (0, 15, 30, 45, 60, 90 and 120 min) following meal consumption, as well as mood and subjective appetite. An ad libitum test meal will be provided at 120 min to assess food intake suppression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| White bread | Experimental | Other: White breadMatched for energy content and available carbohydrate content of potato treatments |
| Baked potato with skin | Experimental | Other: Baked potato with skinBaked russet potato |
| Mashed potato served hot | Experimental | Other: Mashed potato served hotMashed potatoes prepared from frozen, matched for available carbohydrate content of baked potato |
| Fried French fries | Experimental | Other: Fried French friesMatched for available carbohydrate content of baked potato |
| Meal skipping | Experimental | Other: Meal skippingNo food given |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- be between 9 and 14 years of age
- be healthy, and have been born at term
- be a native English speaker
- not be taking any medications
- not have allergies to potatoes, rice, or beans.
Key exclusion criteria (3 listed)
- anyone with food sensitivities or allergies to potatoes or potato-products,
- smokers
- diabetic or overweight/obese individuals.
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 |
|---|---|---|
| White breadToasted, with canola oil added to match for fat content of French fries (13.9 grams), as well as being matched for energy (280 kilocalories) and available carbohydrate content (33 grams) of potato treatments. | Other | White bread |
| Baked potato with skinBaked russet potato with canola oil added once baked to match for fat content of French fries, and also matched for the salt content of white bread (280 milligrams). | Other | Baked potato with skin |
| Mashed potato served hotMashed potatoes prepared from frozen, with canola oil added to match for fat content of French fries, as well as being matched for energy and available carbohydrate content of the baked potato. | Other | Mashed potato served hot |
| Fried French friesPrepared from frozen, matched for energy and available carbohydrate content of baked potato and salt content of white bread. | Other | Fried French fries |
| Meal skippingNo food given | Other | Meal skipping |
Primary outcome
Ad libitum food intake (lunch, at 120 minutes)
Time frame: at 120 minutes post morning meal consumption
Food intake will be determined by weighing the meal before and after serving. The net weight of the test meal will be converted to calories
Change from baseline glycemic response
Time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Blood glucose (mmol/L). Blood glucose will be measured in whole blood using YSI 2300 STAT PLUS (YSI Incorporated, Yellow Springs, OH)
Change from baseline insulin
Time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Blood insulin (pmol/L). Insulin concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
6 secondary outcomes
Change from baseline subjective appetite
Time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline mood
Time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline cholecystokinin (CCK)
Time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline dipeptidyl peptidase 4 (DPP4)
Time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline glucose-dependent insulinotropic peptide (GIP)
Time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
Change from baseline glucagon-like peptide-1 (GLP-1)
Time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
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 30 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Nick Bellissimo, PhD principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White bread, Baked potato with skin and Mashed potato served hot in people with Healthy, run by Toronto Metropolitan University 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 6 inclusion and 3 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 30 Sep 2020. 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?
Ad libitum food intake (lunch, at 120 minutes) (time frame: at 120 minutes post morning meal consumption). The study lists 3 primary outcomes in all. 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 30 Sep 2020.