N/A
N=38
Impacts of Lentils on Metabolism and Inflammation
Hypertriglyceridemia · Inflammation · Waist, Hypertriglyceridemic
Bottom Line
View on ClinicalTrials.gov: NCT04283448 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Postprandial Serum Triglyceride — -0.1; 0.2 mmol*hr/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dietary Lentil (Behavioral); Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montana State University
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Postprandial Serum Triglyceride |
-0.1; 0.2 | — |
| PRIMARY Change in Postprandial Serum Glucose |
-0.7; 0.1 | — |
| PRIMARY Change in Postprandial Serum Inflammatory Cytokines |
-7.59; 3.07; -4.06; 1.09; -12.42; 0.09 | — |
| PRIMARY Change in Fasting Serum Lipids and Glucose |
-0.11; 0.36; -0.07; 0.10; -0.03; 0.30 | — |
| PRIMARY Change in Fasting Inflammatory Cytokines |
1.47; -0.76; 0.65; 0.04; 2.20; 0.26 | — |
| SECONDARY Change in Body Fat Composition |
-1.2; 0.55 | — |
| SECONDARY Change in Visceral Adipose Tissue |
0.08; 0.17 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-0.43; -0.02 | — |
| SECONDARY Perceptions of Hunger, Fullness, Satiety, and Satisfaction After Mid-day Meal During the Intervention |
3.6; 3.9; 6.3; 6.2; 6.2; 6.1 | — |
| SECONDARY Gastrointestinal Symptoms of Bloating, Cramping, Discomfort, and Flatulence During the Intervention |
0.9; 0.8; 0.6; 0.7; 0.2; 0.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Waist circumference > 35 inches for women and > 40 inches for men
- Non-fasting serum triglyceride concentration > 175 mg/dl
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04283448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.