Energy Value of Lentils and Chickpeas

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

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Other: Control Diet; Other: Lentil Containing Diet; Other: Chickpea Containing Diet

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; The placebo comparator will be a fully controlled diet made from typical American foods and containing no beans or pulses.	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.
Experimental: Lentil; The lentil arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain lentils.	Other: Lentil Containing Diet; Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils.
Experimental: Chickpeas; The chickpea arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain chickpeas.	Other: Chickpea Containing Diet; Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Fat excreted in feces	Fat (g) excreted in feces will be measured.	Cumulative from day 10-17, day 39-46, day 57-64

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center
• Investigators: Study Director: Roman Mirecki, MS, US Department of Agriculture

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): March 23, 2020
• Study Completion (Actual): March 23, 2020

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HS66-Lentil/Chickpea Study

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
• product manufactured in and exported from the U.S.: No