NCT06758869

Brief Summary

The purpose of this research is to test how processing can affect how one's body uses the nutrients in that food. For this study the researchers are examining how making different food products out of chickpeas, such as hummus or pasta, changes how one's body uses those foods for energy.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable healthy

Timeline
36mo left

Started Jan 2027

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 19, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

December 19, 2024

Last Update Submit

April 22, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Differences in substrate oxidation in response to eating differentially processed pulse-based food products

    Using whole-room calorimetry, measure differences in fat, carbohydrate, and protein oxidation in response to daily consumption of whole chickpeas, pureed chickpeas, or chickpea-flour pasta compared to a control diet.

    12 weels

  • Change from Baseline in substrate oxidation after consuming differentially processed pulse-based food products for 12 weeks

    Measure changes in fat, carbohydrate, and protein oxidation in response to consuming whole chickpeas, pureed chickpeas, or chickpea-flour pasta using whole room calorimetry

    12 weeks

  • Determine participant consumption practices and attitudes towards pulse consumption using a validated questionnaire

    The questionnaire is designed to assess enjoyment (two items), sensory properties (eight items), perceived cooking abilities (ten items), perceived practical aspects (six items), perceived healthiness (two items), upbringing (two items), social influences (four items), and quality issues (six items) of pulse consumption.

    Baseline

Secondary Outcomes (2)

  • Changes in the colonic microbiota in response to consuming differentially processed pulse-based food products

    12 weeks

  • Changes in me metabolic gene expression and metabolites in response to consuming differentially processed pulse-based food products.

    12 weeks

Study Arms (4)

Control

EXPERIMENTAL

Base DGA diet with a standardized non-pulse product snack

Other: Control

Whole Chickpeas

EXPERIMENTAL

Adjusted DGA diet with standardized whole chickpea snack

Other: Whole Chickpeas

Puréed Chickpeas

EXPERIMENTAL

Adjusted DGA diet with standardized puréed chickpea snack

Other: Puréed Chickpeas

100% Chickpea Flour Product

EXPERIMENTAL

Adjusted DGA diet with standardized 100% chickpea flour product snack

Other: 100% Chickpea Flour Product

Interventions

ControlOTHER

Participants will consume the Base DGA diet with a standardized non-pulse product snack.

Control

Participants will consume an adjusted DGA diet with a standardized whole chickpea snack.

Whole Chickpeas

Participants will consume an adjusted DGA diet with a standardized puréed chickpea snack.

Puréed Chickpeas

Participants will consume an adjusted DGA diet with a standardized 100% chickpea flour product snack.

100% Chickpea Flour Product

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • apparently healthy adults
  • BMI \>18.5 or \<35 kg/m2 (healthy body weight - class I obesity)
  • ability to understand and sign the consent form
  • availability of transportation (i.e., participants must provide their own transportation to the Center)
  • non-smoking or do not use other tobacco products, including e-cigarettes
  • not taking steroid-based medications
  • not planning to or currently attempting to gain or lose weight
  • not allergic to study foods
  • willing to comply with study demands

You may not qualify if:

  • usual pulse consumption greater than DGA recommendation
  • inability or unwillingness to consume any of the provided foods
  • more than a 10% change in body weight within the past 2 months
  • actively trying to lose weight
  • pregnancy or actively trying to get pregnant
  • lactation
  • uncontrolled hypertension (systolic \>160 mmHg or diastolic \>100 mmHg)
  • diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
  • HbA1c ≥ 5.7%
  • complete blood count (CBC) outside of the normal range for a healthy adult
  • history of gastrointestinal (GI) disorders (including Celiac's or Crohn's disease, irritable bowel syndrome, acid reflux, ulcerative colitis, chronic constipation or diarrhea, and lactose intolerance)
  • using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids)
  • cannot read or understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Links

Study Officials

  • Shanon Casperson

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanon Casperson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Biologist

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 6, 2025

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations