Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk

NCT01562171 | Completed

• 1 other identifier: B2012:010
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

Compared to control foods, consumption of 3 cups of cooked lentils given weekly for 12 weeks will significantly improve glucose tolerance and lower LDL-cholesterol in individuals with high cholesterol and obesity.

Conditions

Obesity; Hypercholesterolemia

Keywords

Overweight; Obese; Obesity; Cholesterol; Hypercholesterolemia; LDL-Cholesterol

Outcome Measures

Primary Outcomes (1)

• To examine the effect of lentils on glucose tolerance and LDL-cholesterol.

  12 weeks

Secondary Outcomes (1)

• To examine the effect of lentils on glycated hemoglobin; fasting plasma glucose, insulin, triglycerides, HDL-cholesterol and C-reactive protein.

  12 weeks

Other Outcomes (1)

• To examine the effect of lentils on vascular responsiveness, and biomarkers of vascular function, inflammation and metabolism.

  12 Weeks

Study Arms (2)

Cooked Lentils

EXPERIMENTAL

The study group will be asked to consume food items containing one serving of (0.3 cups) of cooked lentils per day for the first 5 days, followed by one serving of (0.6 cups) of cooked lentils per day 5 times per week (equivalent of 3 cups cooked lentils per week) for the remainder of the 12-week schedule.

Other: Cooked Lentils

Potato-Based Foods

ACTIVE COMPARATOR

The control group will be asked to consume one serving per day of potato-based foods in matrices similar to those containing lentils in the same 12-week schedule, including the smaller serving size for the first 5 days.

Other: Potato-Based Foods

Interventions

Cooked Lentils OTHER

Consume food items containing one serving of (0.3 cups) of cooked lentils per day for the first 5 days, followed by one serving of (0.6 cups) of cooked lentils per day 5 times per week (equivalent of 3 cups cooked lentils per week) for the remainder of the 12-week schedule.

Cooked Lentils

Potato-Based Foods OTHER

Control - Consumption of one serving per day of potato-based foods in matrices similar to those containing lentils in the same 12-week schedule, including the smaller serving size for the first 5 days.

Potato-Based Foods

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating females aged 30 to 75 years;
• Body Mass Index of ≤40 kg/m2 and ≥23 kg/m2 if Asian or ≥25 kg/m2 if non-Asian;
• Waist circumference ≥94 cm for males and ≥80 cm for females of Asian ethnicity,and ≥102 cm for males and ≥88 cm of non-Asian ethnicity;
• Fasting plasma glucose \<7 mmol/L;
• Fasting triglycerides \<4.00 mmol/L and LDL-cholesterol \>2.50 mmol/L and \<5.00 mmol/L;
• Must be on a stable regime for the past 3 months if taking medications to treat hypertension or if taking vitamin and mineral/dietary/herbal supplements;
• Stable body weight (±3 kg) for the past 3 months

You may not qualify if:

• Previous diagnosis of type 2 diabetes;
• High pulse consumption (≥2 servings per week);
• Presence of liver disease (aspartate transaminase \>2 times Upper Normal Limit), renal insufficiency (creatinine \>1.5 times Upper Normal Limit); inflammatory bowel disease or other gastrointestinal disorders influencing gastrointestinal motility or nutrient absorption;
• Use of medication which influence carbohydrate metabolism (i.e., steroids), or medications used to treat diabetes or to lower blood lipids, or any active medical or surgical conditions within the past 3 months;
• Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results;
• History of gastrointestinal reactions or allergies to lentils or potato-based foods, or to one or more ingredients in the study foods which significantly limits the number of study foods that can be consumed.

Sponsors & Collaborators

• University of Manitoba: lead
• Glycemic Index Laboratories, Inc: collaborator
• Agriculture and Agri-Food Canada: collaborator
• Saskatchewan Pulse Growers: collaborator

Study Sites (2)

I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Glycemic Index Laboratories, Incorporated

Toronto, Ontario, M5C 2N8, Canada

Location

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Related Links

• Canadian Centre for Agri-Food Research in Health \& Medicine (website)

MeSH Terms

Conditions

Obesity; Hypercholesterolemia; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Carla Taylor, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Human Nutritional Sciences

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 23, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

CA (2)