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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: Completed NA study, sponsored by Montana State University.
NCT04448067 is a NA study that has completed, run by Montana State University. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood glucose area under the curve during 2-h 75 g oral glucose tolerance (units = mmol/2 h)
Interventions
- BEHAVIORAL Dietary Lentil Intake
- BEHAVIORAL No Dietary Lentil CONTROL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-01-19 |
| Est. Completion | 2019-12-13 |
| Phase | NA |
What the finished NCT04448067 record still lists
NCT04448067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Dietary Lentil Intake is the first listed.
NCT04448067 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04448067's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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