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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 10, 2012
Last Updated Date	October 12, 2012
Start Date ^ICMJE	February 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 12, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01706042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 12, 2012)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE (submitted: October 12, 2012)	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.
Original Other Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Effects of Legumes on Glucose Regulation
Official Title ^ICMJE	Over-night Metabolic Effects of Legumes
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Dietary Prevention
Intervention ^ICMJE	Other: legume meal Other: white bread
Study Arm (s)	Placebo Comparator: white bread White bread (based on 35 g available carbohydrates) Intervention: Other: white bread Active Comparator: Legume meal Legumes are consumed as a late evening meal(based on 35 g available carbohydrates) Intervention: Other: legume meal
Publications *	Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. Epub 2009 Jun 13. Review. Papanikolaou Y, Fulgoni VL 3rd. Bean consumption is associated with greater nutrient intake, reduced systolic blood pressure, lower body weight, and a smaller waist circumference in adults: results from the National Health and Nutrition Examination Survey 1999-2002. J Am Coll Nutr. 2008 Oct;27(5):569-76. Nilsson A, Johansson E, Ekström L, Björck I. Effects of a brown beans evening meal on metabolic risk markers and appetite regulating hormones at a subsequent standardized breakfast: a randomized cross-over study. PLoS One. 2013;8(4):e59985. doi: 10.1371/journal.pone.0059985. Epub 2013 Apr 5.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	16
Completion Date	August 2011
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 35 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01706042
Other Study ID Numbers ^ICMJE	668/2008
Has Data Monitoring Committee	Not Provided
Responsible Party	Anne Nilsson, Lund University
Study Sponsor ^ICMJE	Lund University
Collaborators ^ICMJE	Anti Diabetic Food Centre (Vinn Excellence Centre)
Investigators ^ICMJE	Not Provided
Information Provided By	Lund University
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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