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Completed

NCT Number: NCT04003194

Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes

This study examines the impact of daily consumption of ½ c pinto beans, compared to a control (½ c green beans), on fasting glucose, postprandial glucose and HbA1c concentrations in adults with type 2 diabetes mellitus (T2DM).

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study utilized a randomized, pretest-posttest, crossover (within-group) design, that includes two treatment periods [control period (½ c. green beans each day) and pinto beans (½ c each day)], each 12-weeks in duration with a 4- week wash-out period to determine the impact on fasting glucose, postprandial glucose and HbA1c concentrations. After a baseline wash-in period, 16 participants are randomly assigned to 2 treatment periods [control period and pinto beans], each 12-weeks in duration. On 28 randomized days during the wash-in period and interventions, participants keep diet records and measure a postprandial capillary glucose concentration using a glucometer 1 hour after the meal during which the pinto beans or control are consumed. Before and after each 12-week intervention, participants provide a fasted venous blood sample for glucose and HbA1c analyses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of T2DM by a physician;
  • currently attempting control of T2DM by diet or metformin;
  • fasting glucose ≥ 90 mg/dL (confirmed by fasting blood draw or potential participant provided lab analysis conducted within last 30 days) and/or hemoglobin A1C ≥ 6.5% (confirmed by blood draw or potential participant provided lab analysis conducted within last 30 days);
  • body mass index (BMI) of 22-40 kg/m2;
  • no unresolved health conditions and no diagnosis of gastrointestinal disease;
  • limited history of legume intake;
  • willingness to follow study protocol, scheduling, and ability to come to the testing location;
  • no recent weight gain or loss (>10% over 6 months);
  • no use of medications and/or dietary supplements other than metformin that affected glucose;
  • women could not be pregnant or breastfeeding;
  • habitual alcohol consumption had to be less than 2 drinks per day (specifically ≤ 720 ml of beer, 240 ml of wine, or 90 ml of hard liquor).

Exclusion criteria

  • Non compliance with above inclusion criteria.

Treatment and study plan

Pinto beans

Other

The intervention was 1/2 cup of pinto beans each day.

Other names: Pinto Beans - intervention

Green Beans - control

Other

The control was 1/2 cup of green beans each day.

Other names: Control

Primary outcomes

  1. Change in Glucose

    Time frame: 12 weeks pre and post

    Change in fasting blood glucose levels

Secondary outcomes

  1. Postprandial glucose

    Time frame: 1 time per week from week 1 of each intervention to week 12 of each intervention

    1 time per week from week 1 of each intervention to week 12 of each intervention

  2. Change in Hemoglobin A1c

    Time frame: 12 weeks pre and post

    Change in Blood hemoglobin A1c

Sponsors and collaborators

Lead sponsor

University of Colorado, Colorado Springs

Other

Collaborators

  • Iowa State University

Registry information

Official study title

Impact of Pinto Beans as Part of a Normal Diet on Glycemic Control in Adults With Type 2 Diabetes: a Randomized Trial

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 1, 2019
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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