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NCT04283448 · ClinicalTrials.gov registry record · NA
Impacts of Lentils on Metabolism and Inflammation
A NA study, sponsored by Montana State University.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT04283448: Completed NA study, sponsored by Montana State University.
NCT04283448 is a NA study that has completed, run by Montana State University. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04283448, a NA study, has completed, sponsored by Montana State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
The overall goal of this investigation is to determine gut microbiome dependent and independent impacts of pulse consumption on metabolic resilience and metabolic risk profiles for type 2 diabetes (T2D) and cardiovascular disease (CVD) risk. Specifically, pulse crop consumption has unrealized potential to fundamentally alter how the body responds to disease promoting metabolic stresses of postprandial triglyceride and inflammation responses. The specific objectives are to (1) Determine the impact of green lentil consumption on postprandial triglyceride (TG) and inflammation responses to a high-fat meal challenge. (2) Determine the extent to which the gut microbiome and changes in the gut microbiome induced by pulse consumption influence health impacts (3) Measure metabolomic profiles to elucidate underlying mechanisms linking pulse consumption to improved health. To achieve these objectives investigators will determine the effects of green lentil on high impact risk factors of large postprandial triglyceride excursions and inflammation, composition of and changes in the gut microbiomes, and both gut and serum metabolomes in overweight/obese (OW/OB) individuals with elevated risk. The 12-week intervention will consist of consumption of 4.6 or 0 cups of pulses per week across 7 pre-made meals (matched for macronutrient content (except fiber) provided to experimental and control groups. The following hypotheses will be tested in the proposed investigation: H1: Lentil consumption lower postprandial TG and inflammation responses and improve overall metabolic health. H2: Characteristics of the gut microbiome and changes in the gut microbiome induced by lentil consumption substantially influence health impacts of pulse consumption. H3: Features of the fecal and serum metabolomes distinguishing lentil and control treatments correspond to metabolic pathways elucidating potential gut microbiome dependent and independent mechanisms linking pulse consumption to improved heal
Primary Outcome
Area under the curve for serum triglyceride concentration calculated from 0 - 5 hours post consumption of a meal containing 50 g of fat. Value reported as the change from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).
Interventions
- BEHAVIORAL Control
- BEHAVIORAL Dietary Lentil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2020-05-22 |
| Est. Completion | 2023-11-19 |
| Phase | NA |
What the finished NCT04283448 record still lists
NCT04283448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT04283448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04283448 about?
NCT04283448 is a clinical study titled "Impacts of Lentils on Metabolism and Inflammation". The overall goal of this investigation is to determine gut microbiome dependent and independent impacts of pulse consumption on metabolic resilience and metabolic risk profiles for type 2 diabetes (T2D) and cardiovascular disease (CVD) risk. Specifically, pulse crop consumption has unrealized potent...
What is the current status of trial NCT04283448?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2020-05-22. Estimated completion is 2023-11-19.
What interventions are being tested in trial NCT04283448?
The interventions under investigation include: Control (BEHAVIORAL), Dietary Lentil (BEHAVIORAL).
Who is sponsoring clinical trial NCT04283448?
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 NCT04283448's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 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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