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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05499819
Other study ID # REB-22-03-028
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 18, 2022
Est. completion date November 22, 2023

Study information

Verified date May 2024
Source University of Guelph
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This human clinical trial is using a randomized crossover design to examine the effect of two varieties of beans compared to beef on satiety and food intake in older adults.


Description:

This human clinical trial is using a randomized crossover design that includes 3 study visits separated by washout periods of at least 1 week. Each study visit will last approximately 4 hours and will occur at the Human Nutraceutical Research Unit (HNRU) at the University of Guelph. Study visits will occur in the morning and begin with measurement of fasting body weight. Participants will then complete a baseline satiety questionnaire before they consume a breakfast test meal (that includes either red kidney beans, black beans or extra-lean ground beef). After the breakfast meal, participants will complete a palatability questionnaire. They will also complete more satiety questionnaires at 15, 30, 45, 60, 120, 150 and 180 minutes. After 180 minutes, participants will be consume an ad libitum pizza lunch meal until they are comfortably full. Participants will then be sent home with a food scale and instructions to record everything they eat and drink for the remainder of the day.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date November 22, 2023
Est. primary completion date November 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Healthy males and females - =60 years old - BMI between 18.5-30 kg/m2 Exclusion Criteria: - Medication use that is not at a stable dose (at least 3 months) - Natural health product use that is not at a stable dose (at least 3 months) - Antibiotic use in the past 3 months - Overnight shift work - Alcohol consumption >14 drinks/week or >4 drinks/sitting - Anaphylactic food allergy - Pulse (beans, lentils, chickpeas, dried peas) consumption >4 servings per week - Recent or intended significant weight loss or weight gain (>4 kg in previous 3 months) - Breakfast skipping =4 days per week - Vegan diet - Dislike or unable to consume beans, ground beef, shredded cheddar cheese, white tortilla wraps or frozen cheese pizza - Three Factor Eating Questionnaire scale scores >11 for Cognitive Restraint, >9 for Disinhibition, and >8 for Hunger - Diagnosed hypertension (blood pressure >140/90mmHg) that is not managed - Diagnosed digestive-related condition (i.e. Celiac Disease, constipation, gastritis, gastroesophageal reflux disease, gluten intolerance, hemorrhoids, inflammatory bowel disease (Crohn's, Ulcerative Colitis), irritable bowel syndrome, lactose intolerance) - Diagnosed cognitive-related condition (i.e. Alzheimer's Disease, amnesia, dementia, generalized anxiety disorder, major depressive disorder, Parkinson's Disease, schizophrenia, traumatic brain injury) - Medical condition that does not have stable management for at least 3 months - Medical or surgical event requiring hospitalization in the past 3 months - Tobacco use - Cannabis use - Vape use

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Canned black beans, drained and rinsed
Canned black beans, drained and rinsed and consumed in a tortilla wrap
Canned red kidney beans, drained and rinsed
Canned red kidney beans, drained and rinsed, drained and rinsed and consumed in a tortilla wrap
Extra-lean ground beef
Extra-lean ground beef, pan-fried and consumed in a tortilla wrap

Locations

Country Name City State
Canada Human Nutraceutical Research Unit Guelph Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Guelph Ontario Bean Growers

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective appetite sensations Fullness, satisfaction, hunger, desire to eat, prospective food consumption (measured by a visual analogue scale in mm) Area under the 180 minute curve
Secondary Food intake at an ad libitum pizza meal Food intake will be measured in grams at an ad libitum cheese pizza lunch meal 180 minutes after consumption of study treatment (in a breakfast meal)
Secondary 24-hour energy intake Energy intake measured as kcal for 24 hours after consumption of study treatment (in a breakfast meal) using a weighed food record 24 hours
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