Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-24 @ 12:40 PM
NCT ID:
NCT07065461
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07065461
Study Brief:
Protocol Section:
NCT07065461