Energy Value of Lentils and Chickpeas

NCT ID: NCT03779971

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2020-03-23

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.

Conditions

Healthy Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Control

The placebo comparator will be a fully controlled diet made from typical American foods and containing no beans or pulses.

Group Type: PLACEBO_COMPARATOR

Control Diet

Intervention Type: OTHER

Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain no pulses, legumes, or beans.

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.

Group Type: EXPERIMENTAL

Lentil Containing Diet

Intervention Type: OTHER

Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils.

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.

Group Type: EXPERIMENTAL

Chickpea Containing Diet

Intervention Type: OTHER

Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas.

Interventions

Control Diet

Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain no pulses, legumes, or beans.

Intervention Type: OTHER

Lentil Containing Diet

Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils.

Intervention Type: OTHER

Chickpea Containing Diet

Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Janet Novotny

Research Physiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roman Mirecki, MS

Role: STUDY_DIRECTOR

US Department of Agriculture

Locations

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

Other Identifiers

HS66-Lentil/Chickpea Study

Identifier Type: -

Identifier Source: org_study_id