Energy Value of Lentils and Chickpeas

• ClinicalTrials.gov Identifier: NCT03779971
• Recruitment Status: Completed
• First Posted: December 19, 2018
• Last Update Posted: May 11, 2020
• Sponsor: USDA Beltsville Human Nutrition Research Center
• Information provided by (Responsible Party): Janet Novotny, USDA Beltsville Human Nutrition Research Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy Adults	Other: Control Diet; Other: Lentil Containing Diet; Other: Chickpea Containing Diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Treatments will be color coded, and samples will be labeled only by subject number and date. Investigators and outcomes assessors will not know the treatments nor the color code until after the data analyses are complete.
• Primary Purpose: Basic Science
• Official Title: Energy Value of Lentils and Chickpeas
• Actual Study Start Date: November 6, 2019
• Actual Primary Completion Date: March 23, 2020
• Actual Study Completion Date: March 23, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Energy excreted in feces and urine [ Time Frame: Cumulative from day 10-17 ]
   Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
2. Energy excreted in feces and urine [ Time Frame: Cumulative from day 39-46 ]
   Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
3. Energy excreted in feces and urine [ Time Frame: Cumulative from day 57-64 ]
   Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.

Secondary Outcome Measures :

1. Nitrogen excreted in feces and urine [ Time Frame: Cumulative from day 10-17, day 39-46, day 57-64 ]
   Nitrogen (g) excreted in feces and urine will be measured.
2. Fat excreted in feces [ Time Frame: Cumulative from day 10-17, day 39-46, day 57-64 ]
   Fat (g) excreted in feces will be measured.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Maryland

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States, 20705

Sponsors and Collaborators

USDA Beltsville Human Nutrition Research Center

Investigators

• Study Director: Roman Mirecki, MS; US Department of Agriculture

More Information

• Responsible Party: Janet Novotny, Research Physiologist, USDA Beltsville Human Nutrition Research Center
• ClinicalTrials.gov Identifier: NCT03779971
• Other Study ID Numbers: HS66-Lentil/Chickpea Study
• First Posted: December 19, 2018
• Last Update Posted: May 11, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No