Effects of Lentil Consumption on Post-prandial Blood Glucose and Insulin

Healthy Clinical Trial

Official title:

The Love of Lentils (LoL) Study: The Effects of Acute Consumption of Common Lentil Varieties on Post-prandial Blood Glucose and Insulin Levels in Healthy Adult

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426606
• Other study ID #: 14SE012
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: October 24, 2016
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of consuming various lentil varieties in mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and insulin as compared to white rice or white potato alone.

Description:

Eligible participants will undergo a total of 6 study visits. During each visit, a fasted blood sample will be taken by fingerprick, and approximately 500µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: white bread, white rice (or white potato), or white rice with lentils (or white potato with lentils). White bread will be consumed on the first study visit and the rest of the meals will take place in random order in the visits following. Each meal will provide a total of 50g available carbohydrate. Six more blood samples will be taken by fingerprick at 15, 30, 45, 60, 90 and 120 minutes after the beginning of the meal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy men and women

• Age 18-40 years

• BMI 20-30 kg/m2

Exclusion Criteria:

• Tobacco use

• Pregnant or breastfeeding

• Fasting blood glucose = 7.0 mmol/L

• Any major medical condition including a history of AIDS or hepatitis

• Medical or surgical event requiring hospitalization within 3 months of randomization

• Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications

• Blood pressure >140/90 mm Hg

• Natural health products (NHPs) used for glycemic control

• Probiotic supplements

• Dietary fibre supplements

• Consumption of >4 servings of pulses per week

• Food allergy or non-food life threatening allergy

• Shift workers

• Alcohol consumption >14 drinks/week or >4 drinks/sitting

• Recent or intended significant weight loss or gain (>4 kg in previous 3 months)

• Elite athletes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Various lentil varieties (varying in slow digested starch content)
Randomized, cross-over block design. Comparison of glycemic and insulinemic responses following meals composed of: white rice or white rice combined with 1 of 3 different lentil varieties or white potato or white potato combined with 1 of 3 different lentil varieties Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC. Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit	Guelph	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University of Guelph	Agriculture and Agri-Food Canada, Pulse Canada, Saskatchewan Pulse Growers

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial blood glucose	Different meals will be consumed on separate occasions over 3-6 week period.	Acute- 2 hours following meal	No
Primary	Postprandial blood insulin	Different meals will be consumed on separate occasions over 3-6 week period.	Acute- 2 hours following meal	No