Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus
Completed · Phase 2
Conditions studied: Blood Glucose, Type 2 Diabetes Mellitus
In brief
The study uses a randomized, placebo-controlled experimental design consisting of 4 different test treatments matched on carbohydrate (CHO) content. The three beans are similar in their CHO content amount for ½ cup at \~20 grams CHO. Each of the bean varieties will be served in a \~½ cup serving size with \~ ½ cup of plain steamed white rice (30 grams CHO) for a total of 50 grams of CHO per meal for each of the three test treatments. The 4th placebo or control treatment consists of \~ 7/8 cup of rice alone, an amount consistent with the CHO content of the test meals. Most diabetic meal plans recommend no more than 45-60 grams of CHO per meal. Fifty grams of CHO is a standard amount for glycemic response testing in general. The investigators hypotheses were: * The test meals containing the three bean types in combination with white rice will decrease the participants' glycemic response when eaten as part of a meal. * The reduction in post-prandial glycemia will not differ between bean types in the elicited responses among individuals with type 2 diabetes.
Key facts
- Study ID
- NCT01241253
- Run by
- Arizona State University
- People needed
- 17
- Starts
- 2009-11-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2019-10-31
Who can join
Age: 35 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eligible subjects will be between the ages of 35 and 75, have a body mass index value (BMI) between 22-40 kg/m2, be physician diagnosed with type 2 diabetes for at least six (6) months and currently controlling their blood glucose levels using dietary methods, exercise and/or through the use of oral hypoglycemic agents such as Metformin for at least three(3)months, and have an HbA1c <10%.
You may not qualify if…
- Exclusion criteria included: the presence of unresolved health issues (e.g. hypertension not controlled by medication), evidence of condition(s) that would influence the participant's ability to complete the study such as gastrointestinal disease, weight changes of ≥10% of the participants body weight within a 6 month period, women who are either pregnant or breastfeeding, allergy to beans or latex, an HbA1c level >10% at screening, and the inability to follow study protocol.
Where it is running
- Arizona State University, Nutrition Program — Mesa, Arizona, United States
Full record on ClinicalTrials.gov
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