NCT02465021

Brief Summary

The goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable obesity

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

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

June 3, 2015

Last Update Submit

September 25, 2017

Conditions

ObesityDiabetes

Keywords

SatietyFood intakeBreakfast cereals/snacksPostprandial glycemia

Outcome Measures

Primary Outcomes (1)

  • Food intake

    Food intake (kCal) is assessed 120 min after consumption of the treatments, using an ad libitum pizza lunch design. Participants are asked to eat, during a 20-min period, until feeling comfortably full

    120 minutes

Secondary Outcomes (3)

  • Perceived satiety

    120 minutes

  • Blood glucose

    0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments

  • Blood insulin

    0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments

Other Outcomes (1)

  • Food Recall

    24 hours

Study Arms (6)

Snack bar 1

EXPERIMENTAL

Dietary intervention: 190 Kcal, 12g fat, 14g carbohydrate, 5g fibre, 6g sugar, 10g protein

Other: Dietary intervention

Snack bar 2

EXPERIMENTAL

Dietary intervention: 200 Kcal, 15g fat, 12g carbohydrate, 5g fibre, 4g sugar, 8g protein

Other: Dietary intervention

Snack bar 3

EXPERIMENTAL

Dietary intervention: 210 Kcal, 16g fat, 12g carbohydrate, 2g fibre, 6g sugar, 6g protein

Other: Dietary intervention

Control 1

EXPERIMENTAL

Dietary intervention: Water (500 g)

Other: Dietary intervention

Control 2

EXPERIMENTAL

Dietary intervention: White bread (190 Kcal, 2g fat, 37g carbohydrate, 2g fibre, 3g sugar, 6g protein)

Other: Dietary intervention

Control 3

EXPERIMENTAL

Dietary intervention: Soft baked pretzel (190 Kcal, 2g fat, 38g carbohydrate, 2g fibre, 6g sugar, 4g protein)

Other: Dietary intervention

Interventions

Dietary interventionOTHER

All arms are given to all participants, in a randomized order

Control 1Control 2Control 3Snack bar 1Snack bar 2Snack bar 3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, non-smoking individuals aged 18-55 years with a body mass index of 20.0-29.9 kg/m2

You may not qualify if:

  • Smokers, individuals with diabetes or other cardiometabolic diseases, persons who suffer from gastrointestinal disorders or have had gastric surgery, or people who regularly use bulk laxatives
  • Women with irregular menstruation or who use hormonal contraceptives or hormone replacement therapy
  • Individuals who regularly skip breakfast, have allergies to any of the test food ingredients, or who follow a restrictive diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences, University of Toronto

Toronto, Ontario, M5S3E2, Canada

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • G. Harvey Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 8, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

September 26, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)