Clinical trial NCT03779971: Energy Value of Lentils and Chickpeas
Official title: Energy Value of Lentils and Chickpeas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2018-12-19
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Energy excreted in feces and urine
timeFrame: Cumulative from day 10-17
measure: Energy excreted in feces and urine
timeFrame: Cumulative from day 39-46
measure: Energy excreted in feces and urine
timeFrame: Cumulative from day 57-64
Secondary outcomes:
measure: Nitrogen excreted in feces and urine
timeFrame: Cumulative from day 10-17, day 39-46, day 57-64
measure: Fat excreted in feces
timeFrame: Cumulative from day 10-17, day 39-46, day 57-64
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
affiliation: US Department of Agriculture
name: Roman Mirecki, MS
role: STUDY_DIRECTOR
References: