Clinical trial NCT04003194: Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes
Official title: Impact of Pinto Beans as Part of a Normal Diet on Glycemic Control in Adults With Type 2 Diabetes: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: pulses
legumes
Phaseolus vulgaris L.
glycemic response
Lead sponsor: University of Colorado, Colorado Springs
Sponsor class: OTHER
Collaborators: name: Iowa State University
First posted: 2019-07-01
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Crossover design with 2-12 week intervention and comparator phases separated by a 4-week washout.
Primary purpose: BASIC_SCIENCE

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glucose
timeFrame: 12 weeks pre and post
Secondary outcomes:
measure: Postprandial glucose
timeFrame: 1 time per week from week 1 of each intervention to week 12 of each intervention
measure: Change in Hemoglobin A1c
timeFrame: 12 weeks pre and post
Other outcomes:
Locations:
Study officials:
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