Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes

NCT04003194 | Completed

• 1 other identifier: UCCS09-028
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Type 2 Diabetes

Keywords

pulses; legumes; Phaseolus vulgaris L.; glycemic response

Outcome Measures

Primary Outcomes (1)

• Change in Glucose

  Change in fasting blood glucose levels

  12 weeks pre and post

Secondary Outcomes (2)

• Postprandial glucose

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

• Change in Hemoglobin A1c

  12 weeks pre and post

Study Arms (2)

Pinto beans

EXPERIMENTAL

1/2 cup pinto beans eaten daily by free-living individuals for 12 consecutive weeks.

Other: Pinto Beans

Green beans

ACTIVE COMPARATOR

1/2 cup green beans eaten daily by free-living individuals for 12 consecutive weeks.

Other: Green Beans - control

Interventions

Pinto Beans OTHER

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

Also known as: Pinto Beans - intervention

Pinto beans

Green Beans - control OTHER

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

Also known as: Control

Green beans

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• University of Colorado, Colorado Springs: lead
• Iowa State University: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Crossover Assignment Crossover design with 2-12 week intervention and comparator phases separated by a 4-week washout.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 1, 2019
• Study Start: March 1, 2009
• Primary Completion: December 31, 2010
• Study Completion: December 31, 2010
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share