Impacts of Lentils on Metabolism and Inflammation

NCT04283448 | Completed Results

• 1 other identifier: 58-3060-9-040
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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 health.

Conditions

Hypertriglyceridemia; Inflammation; Waist, Hypertriglyceridemic

Outcome Measures

Primary Outcomes (5)

• Change in Postprandial Serum Triglyceride

  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).

  12 weeks

• Change in Postprandial Serum Glucose

  Area under the curve for serum glucose 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)

  12 weeks

• Change in Postprandial Serum Inflammatory Cytokines

  Area under the curve for inflammatory cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor) concentration calculated from 0 - 5 hours post consumption of a meal containing 50 g of fat. Value reported as the change in AUC for each cytokine from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

  12 weeks

• Change in Fasting Serum Lipids and Glucose

  Concentration of HDL, LDL, TG, and glucose in the serum after an overnight fast. Value reported as the change in value from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

  12 weeks

• Change in Fasting Inflammatory Cytokines

  Concentration of inflammatory cytokines (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor) in the serum after an overnight fast. Value reported as the change from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline)

  12 weeks

Secondary Outcomes (5)

• Change in Body Fat Composition

  12 weeks

• Change in Visceral Adipose Tissue

  12 weeks

• Change in Body Mass Index (BMI)

  12 weeks

• Perceptions of Hunger, Fullness, Satiety, and Satisfaction After Mid-day Meal During the Intervention

  12 weeks

• Gastrointestinal Symptoms of Bloating, Cramping, Discomfort, and Flatulence During the Intervention

  12 weeks

Other Outcomes (1)

• Change in Habitual Diet

  12 months

Study Arms (2)

Lentil

EXPERIMENTAL

0.66 cups lentils

Behavioral: Dietary Lentil

Control

SHAM COMPARATOR

0.0 cups lentils

Behavioral: Control

Interventions

Dietary Lentil BEHAVIORAL

Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.

Lentil

Control BEHAVIORAL

Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Allergy to wheat
• Taking medication that will influence cholesterol, lipids, or inflammation
• Pregnant or use of hormonal contraceptive method
• Have diabetes, a pacemaker, or other health conditions that may interfere with the study outcomes
• Planning to undergo a weight loss intervention or change in exercise regimen

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Nutrition Research Laboratory

Bozeman, Montana, 59717, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia; Inflammation; Hypertriglyceridemic Waist

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Mary P Miles
• Organization: Montana State University

mmiles@montana.edu

406 994-6678

Study Officials

• Mary Miles, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will utilize a parallel intervention of meals with 0.66 cups of lentils each day versus macronutrient-matched (not including fiber) meals with 0 cups of lentils each day for 12 weeks in OW/OB adults with demonstrated risk for T2D and CVD.

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 25, 2020
• Study Start: May 22, 2020
• Primary Completion: November 19, 2023
• Study Completion: November 19, 2023
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)