NCT07065461

Brief Summary

The goal of this clinical trial is to relate chewing behaviours to food intake and postprandial response for a texturally complex food matrix (almonds in white chocolate) in healthy young females. The main questions it aims to answer are:

  • Does the presence or preparation of almonds (whole versus chopped) influence satiation, i.e., the amount consumed at an ad libitum meal?
  • What is the correlation between chewing behaviour, satiation, and changes in postprandial glucose, triacylglycerols, and satiety ratings? Participants will attend the research centre fasted on three occasions to consume an ad libitum meal, complete questionnaires, and provide fasting and postprandial finger prick blood samples.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 1, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

June 26, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

AlmondsParticle sizeSatiationSatietyPostprandial glycemiaPostprandial lipemiaWhite chocolateFood matrixchewing exertion

Outcome Measures

Primary Outcomes (1)

  • Satiation

    Weight (g) of chocolate confection consumed during ad libitum meal

    Baseline

Secondary Outcomes (5)

  • Borg rating of perceived exertion

    Immediately after the ad libitum meal is consumed

  • Eating rate

    Immediately after the ad libitum meal is consumed

  • Blood glucose

    Baseline and 2 hours later

  • Blood triacylglycerols

    Baseline and 3 hours later

  • Postprandial satiety visual analogue scale

    Baseline until 180 minutes

Study Arms (3)

White chocolate with whole almonds

EXPERIMENTAL

Ad libitum serving with 2.25:1 weight per cent chocolate:almonds

Other: 200 g serving of white chocolate-based confection product

White chocolate without almonds

EXPERIMENTAL

Ad libitum serving

Other: 200 g serving of white chocolate-based confection product

White chocolate with chopped almonds

EXPERIMENTAL

Ad libitum serving with 2.25:1 weight per cent chocolate:almonds

Other: 200 g serving of white chocolate-based confection product

Interventions

200 g serving of white chocolate-based confection product

White chocolate with chopped almondsWhite chocolate with whole almondsWhite chocolate without almonds

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18.5-27.9 kg/m\^2 or waist circumference less than 88 cm
  • No known food allergies or sensitivities
  • Non-restrained eaters based on the Three Factor Eating Questionnaire
  • No history of gastrointestinal diseases that may interfere with eating behaviour or digestion
  • Not on medications that affect appetite, digestion, blood sugar regulation, saliva production, or chewing
  • Stable medication use
  • Non-smokers
  • Not gained or lost significant weight during the past 3 months
  • Regular monthly menstrual cycles
  • Not pregnant, lactating, or post-menopausal

You may not qualify if:

  • Diabetes or other metabolic disorders affecting glycemia and overall cardiometabolic health
  • Any food allergies, intolerance, or sensitivities
  • Any life-threatening allergy
  • Pregnant or breastfeeding
  • Participation in another clinical trial
  • Alcohol consumption more than 14 drinks per week
  • Smokers or those with a smoking history or more than 10 years
  • Regular use of recreational drugs (e.g., marijuana, ecstasy, magic mushrooms)
  • Restrained eater as defined by \> 15 on the Three-Factor Eating Questionnaire
  • Unusual sleep patterns
  • Irregular breakfast consumption
  • Recent weight changes or intended weight loss or gain or having lost or gained \>10% of body weight within the last 6 months
  • Using medications known to affect appetite, digestion, blood sugar regulation, lipids, or chewing (excluding oral contraceptives)
  • Experiences dry mouth, in general or due to medication side effects
  • Diagnosed with Sjogren's Syndrome (autoimmune condition linked to severe dry mouth)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Health Sciences

Guelph, Ontario, N1G 2G4, Canada

RECRUITING

Central Study Contacts

Amanda J Wright, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Individuals collecting, entering, and analyzing data will be blinded to treatment.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Acute meal postprandial study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 15, 2025

Study Start

June 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations