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NCT04448067 · ClinicalTrials.gov registry record · NA

Dietary Incorporation of Lentils to Improve Metabolic Health

A NA study, sponsored by Montana State University.

Completed
Registry status
NA
Development phase
35
Enrollment target

NCT04448067 is a NA study that has completed, run by Montana State University. The registered enrollment target is 35 participants.

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The verdict

NCT04448067, a NA study, has completed, sponsored by Montana State University.

COMPLETED
Registry status
NA
Development phase
35 participants
Enrollment target

Study Summary

Approximately 40% of Americans are pre-diabetic or diabetic, mostly in the form of type 2 diabetes (T2D), which is heavily influenced by diet. Three interrelated factors driving the progression of T2D are large glycemic and lipidemic responses after a meal, consumption of excess calories, and increased fat within the abdominal compartment, referred to as visceral adipose tissue (VAT). Available research suggests that these problems may be attenuated with pulse consumption both at the time of consumption and at the next meal, in what is referred to as the second meal effect. Associations between pulse consumption and metabolic health have been measured in observational studies; unfortunately, randomized clinical trials data to establish cause and effect in humans are typically short in duration (≤ 4 weeks), limited to a single dose of pulse consumption (none exclusively for lentils), and not designed to strategically exploit the well-established second meal effect. We expect the impact of lentil intake will be greatest if consumed at the midday meal to offset the magnitude of the response to the large caloric intake typical in the evening. Our overarching hypothesis is that midday lentil consumption in individuals at greater risk for metabolically driven diseases will improve metabolic health. The purpose of this proposal is to determine whether eight weeks of 0, 300, or 600 grams per week of lentils by individuals with elevated VAT will improve insulin sensitivity, hepatic insulin resistance, lipid profiles (total cholesterol, triglycerides, LDL and HDL lipoproteins), inflammation, appetite and satiety, body mass, body composition, and volume of VAT.

Interventions

  • BEHAVIORAL Dietary Lentil Intake
  • BEHAVIORAL No Dietary Lentil CONTROL

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2019-01-19
Est. Completion 2019-12-13
Phase NA

Sponsor

Montana State University

36 total trials

What the Registry Record Tells You About NCT04448067

The ClinicalTrials.gov registry entry for NCT04448067 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montana State University, which has 36 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Dietary Lentil Intake is the first listed.

NCT04448067 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04448067 about?

NCT04448067 is a clinical study titled "Dietary Incorporation of Lentils to Improve Metabolic Health". Approximately 40% of Americans are pre-diabetic or diabetic, mostly in the form of type 2 diabetes (T2D), which is heavily influenced by diet. Three interrelated factors driving the progression of T2D are large glycemic and lipidemic responses after a meal, consumption of excess calories, and increa...

What is the current status of trial NCT04448067?

This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2019-01-19. Estimated completion is 2019-12-13.

What interventions are being tested in trial NCT04448067?

The interventions under investigation include: Dietary Lentil Intake (BEHAVIORAL), No Dietary Lentil CONTROL (BEHAVIORAL).

Who is sponsoring clinical trial NCT04448067?

This trial is sponsored by Montana State University, which has 36 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.