Type 2 Diabetes
Conditions
Keywords
pulses, legumes, Phaseolus vulgaris L., glycemic response
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.
Interventions
OTHERPinto Beans
The intervention was 1/2 cup of pinto beans each day.
OTHERGreen Beans - control
The control was 1/2 cup of green beans each day.
Sponsors
Iowa State University
University of Colorado, Colorado Springs
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Crossover Assignment Crossover design with 2-12 week intervention and comparator phases separated by a 4-week washout.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glucose | 12 weeks pre and post | Change in fasting blood glucose levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial glucose | 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 |
| Change in Hemoglobin A1c | 12 weeks pre and post | Change in Blood hemoglobin A1c |
Outcome results
None listed