Effects of Legumes on Glucose Regulation

This study has been completed.
Sponsor:
Collaborator:
Anti Diabetic Food Centre (Vinn Excellence Centre)
Information provided by (Responsible Party):
Anne Nilsson, Lund University
ClinicalTrials.gov Identifier:
NCT01706042
First received: October 10, 2012
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

Dietary prevention strategies are increasingly recognized as essential to combat the current epidemic of obesity and related metabolic disorders. The purpose of the present study was to evaluate the potential effects of legumes in relation to cardiometabolic risk markers and appetite regulating hormones.


Condition Intervention
Dietary Prevention
Other: legume meal
Other: white bread

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Over-night Metabolic Effects of Legumes

Further study details as provided by Lund University:

Primary Outcome Measures:
  • blood glucose [ Time Frame: 11 hours ] [ Designated as safety issue: No ]
    A portion of legumes or bread was consumed as a late evening meal, blood glucose was measured the next morning at breakfast.


Secondary Outcome Measures:
  • satiety [ Time Frame: 11 hours ] [ Designated as safety issue: No ]
    legumes or bread was consumed as a late evening meal, satiety hormones (PYY, oxyntomodulin)and appetite sensations were determined at a following breakfast.


Other Outcome Measures:
  • inflammatory markers [ Time Frame: 11 hours ] [ Designated as safety issue: No ]
    legumes or bread was consumed as a late evening meal, inflammatory markers (IL-6, IL-8)was determined at a following breakfast.


Enrollment: 16
Study Start Date: February 2010
Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: white bread
White bread (based on 35 g available carbohydrates)
Other: white bread
Active Comparator: Legume meal
Legumes are consumed as a late evening meal(based on 35 g available carbohydrates)
Other: legume meal

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects between 20-35 years
  • With normal BMI and
  • No known metabolic- or gastro intestinal disease

Exclusion Criteria:

  • BMI > 25,
  • Known metabolic disorder or
  • Gastrointestinal problems or disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706042

Locations
Sweden
Applied Nutrition and Food Chemistry, Lund University
Lund, Sweden, SE-22100
Sponsors and Collaborators
Lund University
Anti Diabetic Food Centre (Vinn Excellence Centre)