Recruiting

Observational Study

Sponsor:

University of Guelph

Code:

NCT07065461

Conditions

Satiation, Satiety

Postprandial Glycemia

Postprandial Lipemia

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

200 g serving of white chocolate-based confection product

Study Details

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.

Conditions

Satiation, Satiety

Postprandial Glycemia

Postprandial Lipemia

Study ID

NCT07065461

Start date

Jun 1, 2025

Status verified date

Jul, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Inability to adhere to study protocols
  • Not comfortable providing finger prick blood samples
  • Avoids consuming almonds or chocolate
  • Has temporomandibular joint disorder (TMJ)
  • Has or history or oral cancer
  • Recent dental or jaw surgery
  • Avoids eating hard foods for concerns of dental fractures or for general oral health
  • Individuals with dentures, braces, Invisalign, or other dental implants that cause difficulty chewing

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: White chocolate with whole almonds

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

experimental: White chocolate without almonds

Ad libitum serving

experimental: White chocolate with chopped almonds

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

Interventions

200 g serving of white chocolate-based confection product

200 g serving of white chocolate-based confection product

Primary outcome measure

  • Satiation [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

Department of Human Health Sciences

Recruiting

Guelph, Ontario, Canada, N1G 2G4

Contacts

Principal Investigator:

Amanda J Wright, PhD

More Information

Sponsor

University of Guelph

Last update posted

Jul 15, 2025

Last verified

Jul, 2025

Keywords

  • Almonds
  • Particle size
  • Satiation
  • Satiety
  • Postprandial glycemia
  • Postprandial lipemia
  • White chocolate
  • Food matrix
  • chewing exertion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Guelph on 2025-07-15.