Energy Value of Lentils and Chickpeas

Healthy Adults Clinical Trial

Official title:

Energy Value of Lentils and Chickpeas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779971
• Other study ID #: HS66-Lentil/Chickpea Study
• Status: Completed
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: March 23, 2020

Study information

• Verified date: March 2020
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to determine the digestibility of and available energy from pulses.

Description:

Previous studies have demonstrated that the metabolizable energy (energy available to the body) from tree nuts is less than predicted by the Atwater factors (the standard approach to determining calorie value of a food). The Atwater approach is over 100 years old and is inaccurate for some foods. This study will be conducted to determine the metabolizable energy from two pulses, lentils and chickpeas. The study will be a human nutrition intervention involving consumption of a controlled diet followed by collection of urine and feces.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• BMI between 19 and 38 kg/m2

• Age 25 to 75 years during intervention

Exclusion Criteria:

• Known (self-reported) allergy or adverse reaction to study foods

• Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study

• History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study

• History of certain cancer diagnosis or treatment in the last 3 years

• Smoking or use of tobacco products in the past 6 months

• Suspected or known strictures, fistulas or physiological/mechanical GI obstruction

• Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications

• Unable or unwilling to give informed consent or communicate with study staff

• Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)

• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Other:
• Control Diet
Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain no pulses, legumes, or beans.
• Lentil Containing Diet
Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils.
• Chickpea Containing Diet
Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas.

Locations

Country	Name	City	State
United States	USDA Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy excreted in feces and urine	Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.	Cumulative from day 10-17
Primary	Energy excreted in feces and urine	Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.	Cumulative from day 39-46
Primary	Energy excreted in feces and urine	Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.	Cumulative from day 57-64
Secondary	Nitrogen excreted in feces and urine	Nitrogen (g) excreted in feces and urine will be measured.	Cumulative from day 10-17, day 39-46, day 57-64
Secondary	Fat excreted in feces	Fat (g) excreted in feces will be measured.	Cumulative from day 10-17, day 39-46, day 57-64