Older AdultsNCT05499819
Effect of Beans Compared to Beef on Satiety in Older Adults
A study testing Canned black beans, drained and rinsed, Canned red kidney beans, drained and rinsed and Extra-lean ground beef in people with Older Adults, run by University of Guelph at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Canned black beans, drained and rinsed, Canned red kidney beans, drained and rinsed and Extra-lean ground beef
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 18 May 2022to 22 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females
- ≥60 years old
- BMI between 18.5-30 kg/m2
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Older Adults
- Being tested
- Canned black beans, drained and rinsed, Canned red kidney beans, drained and rinsed, Extra-lean ground beef
- Keywords
- beans, beef, satiety, appetite, food intake, energy intake, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canned black beans, drained and rinsedOther
Canned black beans, drained and rinsed and consumed in a tortilla wrap
Canned red kidney beans, drained and rinsedOther
Canned red kidney beans, drained and rinsed, drained and rinsed and consumed in a tortilla wrap
Extra-lean ground beefOther
Extra-lean ground beef, pan-fried and consumed in a tortilla wrap
| Study group | Role | What they receive |
|---|---|---|
| Black beans | Experimental | Canned black beans, drained and rinsed Receives: Other: Canned black beans, drained and rinsed |
| Red kidney beans | Experimental | Canned red kidney beans, drained and rinsed Receives: Other: Canned red kidney beans, drained and rinsed |
| Extra-lean ground beef | Experimental | Extra-lean ground beef, pan-fried Receives: Other: Extra-lean ground beef |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective appetite sensations
Fullness, satisfaction, hunger, desire to eat, prospective food consumption (measured by a visual analogue scale in mm)
Measured: Area under the 180 minute curve
Secondary outcomes (2)
Food intake at an ad libitum pizza meal
Food intake will be measured in grams at an ad libitum cheese pizza lunch meal
Measured: 180 minutes after consumption of study treatment (in a breakfast meal)
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start18 May 2022
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Bean Growers
- Responsible party
- Principal investigator, Alison Duncan, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499819
- Sponsor's protocol ID
- REB-22-03-028
- Status last verified
- May 2024
- First submitted
- 13 Jun 2022
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fluit MJ, Adams BF, Ribau ZJ, Duncan AM. Beans Improve Satiety to an Effect that Is Not Significantly Different from Beef in Older Adults: A Randomized, Crossover Trial. J Nutr. 2025 Apr;155(4):1193-1201. doi: 10.1016/j.tjnut.2025.02.008. Epub 2025 Feb 14.
PubMed 39954740
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Beans Compared to Beef on Satiety and Food Intake in Older Adults
- ClinicalTrials.gov ID
- NCT05499819
- Acronym / sponsor ID
- REB-22-03-028
- Conditions
- Older Adults
- Keywords
- beans, beef, satiety, appetite, food intake, energy intake, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Ontario Bean Growers
- Study start
- 18 May 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Black beans | Experimental | Other: Canned black beans, drained and rinsedCanned black beans, drained and rinsed |
| Red kidney beans | Experimental | Other: Canned red kidney beans, drained and rinsedCanned red kidney beans, drained and rinsed |
| Extra-lean ground beef | Experimental | Other: Extra-lean ground beefExtra-lean ground beef, pan-fried |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males and females
- ≥60 years old
- BMI between 18.5-30 kg/m2
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canned black beans, drained and rinsedCanned black beans, drained and rinsed and consumed in a tortilla wrap | Other | Black beans |
| Canned red kidney beans, drained and rinsedCanned red kidney beans, drained and rinsed, drained and rinsed and consumed in a tortilla wrap | Other | Red kidney beans |
| Extra-lean ground beefExtra-lean ground beef, pan-fried and consumed in a tortilla wrap | Other | Extra-lean ground beef |
Primary outcome
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)
2 secondary outcomes
Food intake at an ad libitum pizza meal
Time frame: 180 minutes after consumption of study treatment (in a breakfast meal)
24-hour energy intake
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 39954740Fluit MJ, Adams BF, Ribau ZJ, Duncan AM. Beans Improve Satiety to an Effect that Is Not Significantly Different from Beef in Older Adults: A Randomized, Crossover Trial. J Nutr. 2025 Apr;155(4):1193-1201. doi: 10.1016/j.tjnut.2025.02.008. Epub 2025 Feb 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canned black beans, drained and rinsed, Canned red kidney beans, drained and rinsed and Extra-lean ground beef in people with Older Adults, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective appetite sensations (time frame: Area under the 180 minute curve). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.