- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03307681
Effect of White Potatoes on Glycemic Response, Satiety and Food Intake in Children
September 28, 2020 updated by: Nick Bellissimo, Ryerson University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 2K3
- School of Nutrition, Ryerson University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 14 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- anyone with food sensitivities or allergies to potatoes or potato-products,
- smokers
- diabetic or overweight/obese individuals.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: White bread
Matched for energy content and available carbohydrate content of potato treatments
|
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.
|
EXPERIMENTAL: Baked potato with skin
Baked russet potato
|
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).
|
EXPERIMENTAL: Mashed potato served hot
Mashed potatoes prepared from frozen, matched for available carbohydrate content of baked potato
|
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.
|
EXPERIMENTAL: Fried French fries
Matched for available carbohydrate content of baked potato
|
Prepared from frozen, matched for energy and available carbohydrate content of baked potato and salt content of white bread.
|
EXPERIMENTAL: Meal skipping
No food given
|
No food given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at 120 minutes post morning meal consumption
|
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)
|
15, 30, 45, 60, 90, and 120 minutes after meal consumption
|
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).
|
15, 30, 45, 60, 90, and 120 minutes after meal consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline subjective appetite
Time Frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
|
Measured using visual analogue scale (mm).
Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.
|
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
|
Measured using visual analogue scale (mm).
Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.
|
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
|
Blood CCK (pmol/L).
CCK concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
|
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
|
Blood DPP4 (ng/mL).
DPP4 concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
|
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
|
Blood GIP (pmol/L).
GIP concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
|
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
|
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).
|
15, 30, 45, 60, 90, and 120 minutes after meal consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 21, 2018
Primary Completion (ACTUAL)
June 21, 2020
Study Completion (ACTUAL)
June 21, 2020
Study Registration Dates
First Submitted
September 29, 2017
First Submitted That Met QC Criteria
October 6, 2017
First Posted (ACTUAL)
October 12, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 30, 2020
Last Update Submitted That Met QC Criteria
September 28, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REB2017-330 II
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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