- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01706042
Effects of Legumes on Glucose Regulation
October 12, 2012 updated by: Anne Nilsson, Lund University
Over-night Metabolic Effects of Legumes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lund, Sweden, SE-22100
- Applied Nutrition and Food Chemistry, Lund University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: white bread
White bread (based on 35 g available carbohydrates)
|
|
|
Active Comparator: Legume meal
Legumes are consumed as a late evening meal(based on 35 g available carbohydrates)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood glucose
Time Frame: 11 hours
|
A portion of legumes or bread was consumed as a late evening meal, blood glucose was measured the next morning at breakfast.
|
11 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
satiety
Time Frame: 11 hours
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
inflammatory markers
Time Frame: 11 hours
|
legumes or bread was consumed as a late evening meal, inflammatory markers (IL-6, IL-8)was determined at a following breakfast.
|
11 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
- 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. doi: 10.1080/07315724.2008.10719740.
- Nilsson A, Johansson E, Ekstrom L, Bjorck 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
October 10, 2012
First Submitted That Met QC Criteria
October 12, 2012
First Posted (Estimate)
October 15, 2012
Study Record Updates
Last Update Posted (Estimate)
October 15, 2012
Last Update Submitted That Met QC Criteria
October 12, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 668/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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