Effect of Beans Compared to Beef on Satiety in Older Adults

Sponsor

University of Guelph (Other)

Overall Status

Recruiting

CT.gov ID

NCT05499819

Collaborator

Ontario Bean Growers (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Older Adults	Other: Canned black beans, drained and rinsed Other: Canned red kidney beans, drained and rinsed Other: Extra-lean ground beef	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The Effect of Beans Compared to Beef on Satiety and Food Intake in Older Adults

Actual Study Start Date :

May 18, 2022

Anticipated Primary Completion Date :

May 18, 2023

Anticipated Study Completion Date :

May 18, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Black beans Canned black beans, drained and rinsed	Other: Canned black beans, drained and rinsed Canned black beans, drained and rinsed and consumed in a tortilla wrap
Experimental: Red kidney beans Canned red kidney beans, drained and rinsed	Other: Canned red kidney beans, drained and rinsed Canned red kidney beans, drained and rinsed, drained and rinsed and consumed in a tortilla wrap
Experimental: Extra-lean ground beef Extra-lean ground beef, pan-fried	Other: Extra-lean ground beef Extra-lean ground beef, pan-fried and consumed in a tortilla wrap

Arm

Intervention/Treatment

Experimental: Black beans

Canned black beans, drained and rinsed

Other: Canned black beans, drained and rinsed

Canned black beans, drained and rinsed and consumed in a tortilla wrap

Experimental: Red kidney beans

Canned red kidney beans, drained and rinsed

Other: Canned red kidney beans, drained and rinsed

Canned red kidney beans, drained and rinsed, drained and rinsed and consumed in a tortilla wrap

Experimental: Extra-lean ground beef

Extra-lean ground beef, pan-fried

Other: Extra-lean ground beef

Extra-lean ground beef, pan-fried and consumed in a tortilla wrap

Outcome Measures

Primary Outcome Measures

Subjective appetite sensations [Area under the 180 minute curve]
Fullness, satisfaction, hunger, desire to eat, prospective food consumption (measured by a visual analogue scale in mm)

Secondary Outcome Measures

Food intake at an ad libitum pizza meal [180 minutes after consumption of study treatment (in a breakfast meal)]
Food intake will be measured in grams at an ad libitum cheese pizza lunch meal
24-hour energy intake [24 hours]
Energy intake measured as kcal for 24 hours after consumption of study treatment (in a breakfast meal) using a weighed food record

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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