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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: White bread
Matched for energy content and available carbohydrate content of potato treatments
Other: White bread
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
Other: Baked potato with skin
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
Other: Mashed potato served hot
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
Other: Fried French fries
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
Other: Meal skipping
No food given

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ryerson University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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