Effects of Legumes on Glucose Regulation

Dietary Prevention Clinical Trial

Official title:

Over-night Metabolic Effects of Legumes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706042
• Other study ID #: 668/2008
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: October 12, 2012
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2012
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board in Lund
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dietary Prevention

Intervention

Other:
• legume meal

• white bread

Locations

Country	Name	City	State
Sweden	Applied Nutrition and Food Chemistry, Lund University	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Anti-Diabetic Food Centre

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View Citation

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. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	inflammatory markers	legumes or bread was consumed as a late evening meal, inflammatory markers (IL-6, IL-8)was determined at a following breakfast.	11 hours	No
Primary	blood glucose	A portion of legumes or bread was consumed as a late evening meal, blood glucose was measured the next morning at breakfast.	11 hours	No
Secondary	satiety	legumes or bread was consumed as a late evening meal, satiety hormones (PYY, oxyntomodulin)and appetite sensations were determined at a following breakfast.	11 hours	No