NCT02820805

Brief Summary

The purpose of this study is to determine the effect of carbohydrates on blood glucose levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight (NW) and overweight or obese (OW/OB) children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

June 27, 2016

Last Update Submit

August 7, 2017

Conditions

Keywords

childrendietary carbohydratessolanum tuberosumcognitionmemoryemotionsblood glucose

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

    Participants will participate in a battery of tests that include two learning and memory tasks and two attention tasks at 10, 30, 60, 120, and 180 minutes after meal consumption.

    10, 30, 60, 120, 180 minutes after meal consumption

Secondary Outcomes (2)

  • Blood glucose response

    Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption

  • Subjective Appetite and Mood

    Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption

Study Arms (6)

Meal skipping

EXPERIMENTAL

No meal given

Other: Meal Skipping

Mashed potatoes

EXPERIMENTAL

Carbohydrate Test Meal (50 g of available carbohydrates)

Other: Mashed potatoes

French fries

EXPERIMENTAL

Carbohydrate Test Meal (50 g of available carbohydrates)

Other: French fries

Hash browns

EXPERIMENTAL

Carbohydrate Test Meal (50 g of available carbohydrates)

Other: Hash browns

Rice

EXPERIMENTAL

Carbohydrate Test Meal (50 g of available carbohydrates)

Other: Rice

Beans

EXPERIMENTAL

Carbohydrate Test Meal (50 g of available carbohydrates)

Other: Beans

Interventions

No meal

Meal skipping

50g of available carbohydrates meal

French fries

50g of available carbohydrates meal

Mashed potatoes

50g of available carbohydrates meal

Hash browns
RiceOTHER

50g of available carbohydrates meal

Rice
BeansOTHER

50g of available carbohydrates meal

Beans

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)
  • OW/OB (\>85th BMI percentile for age and gender)

You may not qualify if:

  • Food sensitivities, allergies, or dietary restrictions
  • Health, learning, emotional, or behaivoural problems
  • Receiving any medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nutrition, Ryerson University

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

lunatusin, Phaseolus lunatus

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, School of Nutrition

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 1, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations