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NCT04283448Completed

Impacts of Lentils on Metabolism and Inflammation

Gut Microbiota Dependent and Independent Impacts of Dietary Pulses on Pre- and Postprandial Metabolism and Inflammation in Overweight/Obese Humans

Source: ClinicalTrials.gov · Last updated 13 Dec 2024

Brief summary (registry, in English)

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 health.

Status (registry)
Completed
Study type
Interventional
Enrollment
38 (actual)
First submitted
5 Feb 2020
Start date
22 May 2020
Primary completion date
19 Nov 2023
Lead sponsor
Montana State University
Diseases
Obesity
NCT number
NCT04283448

What you commit to

  • Study type: Interventional
  • Participants enrolled: 38
  • From 22 May 2020 to the primary completion date, 19 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Taking medication that will influence cholesterol, lipids, or inflammation

Other illness

  • Allergy to wheat
  • Have diabetes, a pacemaker, or other health conditions that may interfere with the study outcomes

Other

  • Pregnant or use of hormonal contraceptive method
  • Planning to undergo a weight loss intervention or change in exercise regimen

Who the study is looking for

  • Waist circumference \> 35 inches for women and \> 40 inches for men
  • Non-fasting serum triglyceride concentration \> 175 mg/dl

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nutrition Research Laboratory
Coordinator of this site? Confirm its status
BozemanUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.