Clinical trial NCT05499819: Effect of Beans Compared to Beef on Satiety in Older Adults
Official title: The Effect of Beans Compared to Beef on Satiety and Food Intake in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Keywords: beans
beef
satiety
appetite
food intake
energy intake
older adults
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Ontario Bean Growers
First posted: 2022-08-12
Enrollment: 35
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective appetite sensations
timeFrame: Area under the 180 minute curve
Secondary outcomes:
measure: Food intake at an ad libitum pizza meal
timeFrame: 180 minutes after consumption of study treatment (in a breakfast meal)
measure: 24-hour energy intake
timeFrame: 24 hours
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit
state: Ontario
Study officials:
References: