Dietary Incorporation of Lentils to Improve Metabolic Health

NCT04448067 | Completed

• 1 other identifier: USA DPLC MILES
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Waist, Hypertriglyceridemic

Keywords

glycemic control; inflammation; triglyceride; satiety; gastrointestinal comfort; pulse crop; lentil

Outcome Measures

Primary Outcomes (11)

• Glucose Tolerance

  Blood glucose area under the curve during 2-h 75 g oral glucose tolerance (units = mmol/2 h)

  Week 8

• Insulin Response During Glucose Tolerance Test

  Serum insulin area under the curve during 2-h 75 g oral glucose tolerance test (units = pmol/2 h)

  Week 8

• Visceral Adipose Tissue

  Volume of adipose tissue within the abdominal compartment (units = liters)

  Week 8

• Body Mass

  Total body mass (units = kg)

  Week 8

• Hunger during the 8-week Intervention

  Subjective rating at 4:00 pm in response to the question: "How hungry are you?" (Ordinal scale ratings from 0 = not at all to 10 = extremely). Lower rating of hunger is a better outcome.

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8

• Fullness during the 8-week Intervention

  Subjective rating at 4:00 pm in response to the question: "How full are you?" (Ordinal scale ratings from 0 = not at all to 10 = extremely). Higher rating of fullness is a better outcome.

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8

• Satiety during the 8-week Intervention

  Subjective rating at 4:00 pm in response to the question: "How satisfied do you feel?"(Ordinal scale ratings from 0 = not at all, 10 = extremely). Higher rating of satiety is a better outcome.

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8

• Desire to Eat during the 8-week Intervention

  Subjective rating at 4:00 pm in response to the question: "How strong is your desire to eat?" (Ordinal scale ratings from 0 = nothing to 10 = very large amount). Lower rating of desire to eat is a better outcome.

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8

• Appetite during the 8-week Intervention

  Subjective rating at 4:00 pm in response to the question: "How much do you think you could (or would want to) eat right now?" (Ordinal scale ratings from 0 = nothing to 10 = very large amount). Lower rating of appetite is a better outcome.

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8

• Gastrointestinal Comfort during the 8-week Intervention

  Subjective ratings of level of flatulance, bloating, cramping, and abdominal discomfort participants experienced after eating study meals. (Ratings = none, mild, moderate, severe)

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8

• Serum Metabolome

  Serum metabolites (untargeted) measured from fasting serum (units can be either mmol or area under the curve)

  Week 8

Secondary Outcomes (4)

• Fasting lipid panel

  Week 8

• Fasting glucose

  Week 8

• C-reactive protein

  Week 8

• Inflammatory cytokines

  Week 8

Other Outcomes (2)

• Physical Activity during the 8-week Intervention

  Week 1, Week 8

• Diet

  Day 0

Study Arms (3)

LOW Lentil Intake

EXPERIMENTAL

Consumption of meals containing 60 g of lentils 5 out of 7 days per week for 8 weeks.

Behavioral: Dietary Lentil Intake

HIGH Lentil Intake

EXPERIMENTAL

Consumption of meals containing 120 g of lentils 5 out of 7 days per week for 8 weeks

Behavioral: Dietary Lentil Intake

CONTROL

SHAM COMPARATOR

Consumption of meals matched in total energy and protein to the lentil meals but containing 0 g of lentils 5 out 7 days per week for 8 weeks

Behavioral: No Dietary Lentil CONTROL

Interventions

Dietary Lentil Intake BEHAVIORAL

Dietary intake of moderate or high dose of lentils at midday meals

HIGH Lentil Intake; LOW Lentil Intake

No Dietary Lentil CONTROL BEHAVIORAL

Dietary intake of meals without lentils and matched to dietary lentil meals for total energy and protein

CONTROL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI = or \> than 27 kg/m\^2
• Waist circumference \> 35 inches for women and \> 40 inches for men

You may not qualify if:

• Allergy to wheat
• Taking medication that will influence glucose, cholesterol, lipids, or inflammation
• Pregnant
• Diabetes
• Having a pacemaker
• Other health conditions that may interfere with study outcomes
• Planning a weight loss or change in exercise regimen

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemic Waist; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Mary P Miles, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

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 utilized a parallel intervention of meals with 0, 60 or 120 g of lentils 5 days per week for 8 in overweight or obese adults with elevated waist circumference.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 25, 2020
• Study Start: January 19, 2019
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)