- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06123208
Impact of Eating Beans on Metabolism
November 13, 2023 updated by: Shanon Casperson, USDA Grand Forks Human Nutrition Research Center
The Influence of the Resistant Starch and Protein Content of Pulses on Substrate Oxidation
The purpose of this research is to test how eating a meal containing beans impacts how participants' bodies use food for energy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective of this project is to test whether consuming a whole food that naturally contains resistant starch (RS), such as pulses, increases fat oxidation.
The primary hypothesis is that consuming a RS-rich meal in which the RS is derived from a whole food (i.e., pinto beans, pinto bean flour) will increase postprandial fat oxidation to a greater extent than consuming a meal low in RS but containing the same amount of energy and macronutrient content.
Study Type
Interventional
Enrollment (Estimated)
28
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 Contact
- Name: Afrina Brishti, PhD
- Phone Number: 701-795-8231
- Email: afrina.brishti@usda.gov
Study Contact Backup
- Name: Madelyn Munoz
- Phone Number: 701-795-8343
- Email: madelyn.munoz@usda.gov
Study Locations
-
-
North Dakota
-
Grand Forks, North Dakota, United States, 58203
- Recruiting
- USDA Grand Forks Human Nutrition Research Center
-
Contact:
- Angela J Scheett, MPH, RDN
- Phone Number: 701-795-8386
- Email: angela.scheett@usda.gov
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- BMI >18.5 or <30 kg/m2
- Ability to understand and sign the consent form
- Ability of transportation (i.e., participants must be able to provide their own transportation to the Grand Forks Human Nutrition Research Center)
- Non-smoking or use of other tobacco products, including e-cigarettes
- Not taking steroid-based medications; not planning to or currently attempting to gain or lose weight
- All females of childbearing age must be on birth control for a minimum of 3 months prior to start of study
Exclusion Criteria:
- Inability or unwillingness to consume any food item in the test meals
- More than a 10% change in body weight within the past 2 months
- Participation in a weight loss diet/exercise program
- Current or planned pregnancy
- Lactation
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
- Fasting glucose > 100 mg/dL or non-fasting (1-2 hours after eating) >140 mg/dL
- Using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids, antidepressants)
- Non-English speaking
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: Whole cooked pinto bean meal
Participants will consume a meal comprised of 100 grams of whole cooked pinto beans
|
Meal comprised of whole cooked pinto beans
|
Experimental: Pinto bean flour meal
Participants will consume a meal comprised of pinto bean flour equivalent to 100 grams of whole cooked pinto beans
|
Meal comprised of pinto bean flour
|
Active Comparator: Control meal
Participants will consume a control meal
|
Control meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute effects of consuming processed pulse-based food products on substrate utilization
Time Frame: 5 hours after meal consumption
|
The effect of consuming whole beans or bean-derived flour on the use of fat, carbohydrate, and protein for energy will be determine using whole room calorimetry.
Fat, carbohydrate, and protein oxidation will be calculated as an absolute amount of grams per day and as a percentage of energy expenditure.
|
5 hours after meal consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shanon Casperson, PhD, USDA Grand Forks Human Nutrition Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 30, 2023
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
October 30, 2023
First Submitted That Met QC Criteria
November 3, 2023
First Posted (Actual)
November 8, 2023
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFHNRC513
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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