Energy Value of Lentils and Chickpeas

Not Applicable

Completed

• Conditions: Healthy Adults
• Interventions: Other: Lentil Containing Diet; Other: Control Diet; Other: Chickpea Containing Diet

• Registration Number: NCT03779971
• Lead Sponsor: USDA Beltsville Human Nutrition Research Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-11-06
• Status Verified: 2020-03
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-23
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lentil	Lentil Containing Diet	The lentil arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain lentils.
Control	Control Diet	The placebo comparator will be a fully controlled diet made from typical American foods and containing no beans or pulses.
Chickpeas	Chickpea Containing Diet	The chickpea arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain chickpeas.

Primary Outcome Measures

Name	Time	Method
Energy excreted in feces and urine	Cumulative from day 57-64	Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.

Secondary Outcome Measures

Name	Time	Method
Nitrogen excreted in feces and urine	Cumulative from day 10-17, day 39-46, day 57-64	Nitrogen (g) excreted in feces and urine will be measured.
Fat excreted in feces	Cumulative from day 10-17, day 39-46, day 57-64	Fat (g) excreted in feces will be measured.

Trial Locations

Locations (1)

USDA Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States