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Completed

NCT Number: NCT03779971

Energy Value of Lentils and Chickpeas

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

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Key information

Conditions

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control diet

Other

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

Lentil Containing Diet

Other

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

Chickpea Containing Diet

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2018
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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