NCT03307681

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 21, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2020

Completed
Last Updated

September 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

September 29, 2017

Last Update Submit

September 28, 2020

Conditions

Healthy

Keywords

White potatoesChildrenSatietyGlycaemia

Outcome Measures

Primary Outcomes (3)

  • 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

    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)

    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).

    15, 30, 45, 60, 90, and 120 minutes after meal consumption

Secondary Outcomes (6)

  • Change from baseline subjective appetite

    15, 30, 45, 60, 90, and 120 minutes after meal consumption

  • Change from baseline mood

    15, 30, 45, 60, 90, and 120 minutes after meal consumption

  • Change from baseline cholecystokinin (CCK)

    15, 30, 45, 60, 90, and 120 minutes after meal consumption

  • Change from baseline dipeptidyl peptidase 4 (DPP4)

    15, 30, 45, 60, 90, and 120 minutes after meal consumption

  • Change from baseline glucose-dependent insulinotropic peptide (GIP)

    15, 30, 45, 60, 90, and 120 minutes after meal consumption

  • +1 more secondary outcomes

Study Arms (5)

White bread

EXPERIMENTAL

Matched for energy content and available carbohydrate content of potato treatments

Other: White bread

Baked potato with skin

EXPERIMENTAL

Baked russet potato

Other: Baked potato with skin

Mashed potato served hot

EXPERIMENTAL

Mashed potatoes prepared from frozen, matched for available carbohydrate content of baked potato

Other: Mashed potato served hot

Fried French fries

EXPERIMENTAL

Matched for available carbohydrate content of baked potato

Other: Fried French fries

Meal skipping

EXPERIMENTAL

No food given

Other: Meal skipping

Interventions

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.

White bread
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).

Baked potato with skin
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.

Mashed potato served hot
Fried French friesOTHER

Prepared from frozen, matched for energy and available carbohydrate content of baked potato and salt content of white bread.

Fried French fries
Meal skippingOTHER

No food given

Meal skipping

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • anyone with food sensitivities or allergies to potatoes or potato-products,
  • smokers
  • diabetic or overweight/obese individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nutrition, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Study Officials

  • Nick Bellissimo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 12, 2017

Study Start

December 21, 2018

Primary Completion

June 21, 2020

Study Completion

June 21, 2020

Last Updated

September 30, 2020

Record last verified: 2020-03

Locations

CA(1)