- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05499819
Effect of Beans Compared to Beef on Satiety in Older Adults
May 9, 2024 updated by: Alison Duncan, University of Guelph
The Effect of Beans Compared to Beef on Satiety and Food Intake in Older Adults
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- Human Nutraceutical Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Black beans
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
|
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
|
Extra-lean ground beef, pan-fried and consumed in a tortilla wrap
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective appetite sensations
Time Frame: Area under the 180 minute curve
|
Fullness, satisfaction, hunger, desire to eat, prospective food consumption (measured by a visual analogue scale in mm)
|
Area under the 180 minute curve
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food intake at an ad libitum pizza meal
Time Frame: 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
|
180 minutes after consumption of study treatment (in a breakfast meal)
|
24-hour energy intake
Time Frame: 24 hours
|
Energy intake measured as kcal for 24 hours after consumption of study treatment (in a breakfast meal) using a weighed food record
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2022
Primary Completion (Actual)
November 22, 2023
Study Completion (Actual)
November 22, 2023
Study Registration Dates
First Submitted
June 13, 2022
First Submitted That Met QC Criteria
August 11, 2022
First Posted (Actual)
August 12, 2022
Study Record Updates
Last Update Posted (Actual)
May 10, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REB-22-03-028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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