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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06123208
Other study ID # GFHNRC513
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date November 2025

Study information

Verified date May 2024
Source USDA Grand Forks Human Nutrition Research Center
Contact Afrina Brishti, PhD
Phone 701-795-8231
Email afrina.brishti@usda.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to test how eating a meal containing beans impacts how participants' bodies use food for energy.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Whole cooked pinto bean
Meal comprised of whole cooked pinto beans
Pinto bean flour
Meal comprised of pinto bean flour
Control
Control meal

Locations

Country Name City State
United States USDA Grand Forks Human Nutrition Research Center Grand Forks North Dakota

Sponsors (1)

Lead Sponsor Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute effects of consuming processed pulse-based food products on substrate utilization 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
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