NCT03207607

Brief Summary

The purpose of this study was to determine the effect of mid-morning gel snacks on subjective appetite, glucose and insulin responses, and food intake in healthy weight young adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

February 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
Last Updated

July 5, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 29, 2017

Last Update Submit

July 3, 2017

Conditions

SatietyFood Intake

Keywords

AdultsSnacksAppetiteBlood glucoseInsulin

Outcome Measures

Primary Outcomes (1)

  • Subjective Appetite

    Participants completed subjective ratings on appetite (e.g., desire to eat, hunger, fullness, prospective food consumption) and well-being at baseline (0 min), 15, 30, 45, 60, 90, and 120 min after snack consumption, as well as immediately following lunch.

    Change from baseline over 120 minutes

Secondary Outcomes (3)

  • Blood Glucose Response

    Change from baseline over 120 minutes

  • Blood Insulin Response

    Change from baseline over 120 minutes

  • Food Intake

    30 min

Study Arms (6)

Control snack

EXPERIMENTAL

Participants received control snacks prepared by real fruits (pear, orange and mango)

Other: Control snack

Maltodextrin snack

EXPERIMENTAL

Participants received maltodextrin snacks (maltodextrin + control snack)

Other: Maltodextrin snack

Whey protein snack

EXPERIMENTAL

Participants received whey protein snacks (whey protein + control snack)

Other: Whey protein snack

Oat snack

EXPERIMENTAL

Participants received oat snacks (oat + maltodextrin + control snack)

Other: Oat snack

Coconut oil snack

EXPERIMENTAL

Participants received coconut oil snacks (coconut oil + control snack)

Other: Coconut oil snack

Snack skipping

EXPERIMENTAL

Participants received snack skipping

Other: Snack skipping

Interventions

Control snackOTHER

Isovolumetric (238.4g) gel snack prepared by real fruits (186.2kcal)

Control snack
Maltodextrin snackOTHER

Isovolumetric (238.4g) gel snack with maltodextrin (271.8kcal)

Maltodextrin snack
Whey protein snackOTHER

Isovolumetric (238.4g) gel snack with whey protein (201.8kcal)

Whey protein snack
Oat snackOTHER

Isovolumetric (238.4g) gel snack with oats and maltodextrin (275.8kcal)

Oat snack
Coconut oil snackOTHER

Isovolumetric (238.4g) gel snack with coconut oil (276.4kcal)

Coconut oil snack
Snack skippingOTHER

no snack

Snack skipping

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • be between 18 and 30 years of age
  • be healthy, non-smoking and not be taking any medications, including birth control
  • body mass index (BMI) between 20 and 24.9

You may not qualify if:

  • fasting plasma glucose \>5.5 mmol/L
  • health problems including previously diagnosed diabetes, known or uncertain pregnancy status at screening, gastrointestinal disease, liver or kidney disease
  • major medical or surgical event within the past 6 months
  • current or recent dieting
  • breakfast skipping
  • receiving any medications
  • menstrual irregularities
  • food sensitivities, allergies, intolerances, or dietary restrictions to foods including: cereal, orange juice, dairy, oat, coconut oil, honey, apple, pineapple, strawberry, and pear
  • behavioural or emotional problems
  • alcohol consumption \>7 beverages/week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nutrition, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nick Bellissimo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

  • Derick Rousseau, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Coded snacks in shaded tetrapaks were provided to participants
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 5, 2017

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

July 5, 2017

Record last verified: 2017-06

Locations

CA(1)