NCT01706042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

6 months

First QC Date

October 10, 2012

Last Update Submit

October 12, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • satiety

    11 hours

Other Outcomes (1)

  • inflammatory markers

    11 hours

Study Arms (2)

white bread

PLACEBO COMPARATOR

White bread (based on 35 g available carbohydrates)

Other: white bread

Legume meal

ACTIVE COMPARATOR

Legumes are consumed as a late evening meal(based on 35 g available carbohydrates)

Other: legume meal

Interventions

Legume meal
white bread

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • BMI \> 25,
  • Known metabolic disorder or
  • Gastrointestinal problems or disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Nutrition and Food Chemistry, Lund University

Lund, SE-22100, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 19526214BACKGROUND
  • 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.

    PMID: 18845707BACKGROUND
  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lector

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 15, 2012

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2011

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations