NCT05499819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2023

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

June 13, 2022

Last Update Submit

May 9, 2024

Conditions

Keywords

beansbeefsatietyappetitefood intakeenergy intakeolder adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Food intake at an ad libitum pizza meal

    180 minutes after consumption of study treatment (in a breakfast meal)

  • 24-hour energy intake

    24 hours

Study Arms (3)

Black beans

EXPERIMENTAL

Canned black beans, drained and rinsed

Other: Canned black beans, drained and rinsed

Red kidney beans

EXPERIMENTAL

Canned red kidney beans, drained and rinsed

Other: Canned red kidney beans, drained and rinsed

Extra-lean ground beef

EXPERIMENTAL

Extra-lean ground beef, pan-fried

Other: Extra-lean ground beef

Interventions

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

Black beans

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

Red kidney beans

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

Extra-lean ground beef

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males and females
  • ≥60 years old
  • BMI between 18.5-30 kg/m2

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2022

First Posted

August 12, 2022

Study Start

May 18, 2022

Primary Completion

November 22, 2023

Study Completion

November 22, 2023

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations