CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Control diet +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04887584
NCT04887584N/ACompleted

Identifying the Role of Pulses in a Healthful Diet: Metabolomic Signatures of Dietary Pulses and Their Benefits on Cardiometabolic Risk Factors

USDA, Western Human Nutrition Research Center·interventional·Posted May 14, 2021·Updated Oct 26, 2024

In Brief

A clinical study evaluating Control diet, Low Pulse diet, and 1 other intervention for Body Weight. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Dietary pulses, including beans, chickpeas, and lentils, are high in soluble fiber with potential benefits to human health: Pulses are moderate energy density foods, low in fat and high in dietary protein, fiber, vitamins and minerals. Moderate pulse consumption is associated with improvements in glycemic control and reduced risk of cardiovascular disease, obesity and type 2 diabetes. Measuring pulse consumption in humans is difficult, due to limitations in current methods for dietary assessment which are largely based on dietary recalls that are subject to reporting bias. Robust tools for pulse intake assessment are needed, and biomarkers of dietary pulse intake are one approach to solve this problem. The goal of this human feeding study is evaluate the presence of biomarkers of dietary pulses in human subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBody Weight
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 14, 2021
Enrollment StartMay 1, 2022
Primary CompletionNov 7, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.1 years ago

Interventions

Control dietother

The control Typical American Diet (TAD) diet pattern will mimic the level of intake of fruits, vegetables, whole grains, added sugars, saturated fats and sodium in the general U.S. population. This diet will feature no servings of pulses per day.

Low Pulse dietother

The Low Pulse diet will be designed based on the TAD with substitution of pulses for lean meat and grains. This diet will feature 0.2 cups of pulses per day at 2,000 kilocalories (kcals).

High Pulse dietother

The High Pulse diet will be designed based on the TAD with substitution of pulses for lean meat and grains. This diet will feature 1.5 cups of pulses per day at 2,000 kilocalories (kcals).