NCT03779971

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

November 6, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
Last Updated

May 11, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

December 14, 2018

Last Update Submit

May 7, 2020

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Nitrogen excreted in feces and urine

    Cumulative from day 10-17, day 39-46, day 57-64

  • Fat excreted in feces

    Cumulative from day 10-17, day 39-46, day 57-64

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Other: Control Diet

Lentil

EXPERIMENTAL

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

Chickpeas

EXPERIMENTAL

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

Interventions

Control DietOTHER

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

Control
Lentil Containing DietOTHER

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

Lentil
Chickpea Containing DietOTHER

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

Chickpeas

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 19 and 38 kg/m2
  • Age 25 to 75 years during intervention

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Officials

  • Roman Mirecki, MS

    US Department of Agriculture

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Physiologist

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 19, 2018

Study Start

November 6, 2019

Primary Completion

March 23, 2020

Study Completion

March 23, 2020

Last Updated

May 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)