Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 35 - 70 |
| Updated: | 1/12/2018 |
| Start Date: | November 2009 |
| End Date: | April 2010 |
Glycemic Response of Bean-and-rice Meals in Persons With Type 2 Diabetes Mellitus
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.
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.
The 4 test treatments will be administered randomly on a different morning, at least one week
apart. Participants will be required to consume the entire test treatment meal in 7 minutes
while being observed. All test foods will be purchased from local markets. Capillary blood
samples will be collected (~50µl) at time 0 (fasting) and at 30, 60, 90, 120 and 180 minutes
post-treatment (timing of the post-treatment blood draws started at time 0 [post-treatment],
which is when the participant finishes consuming the treatment meal). Venous blood draws for
insulin assessment will also be acquired at fasting and then every hour for the three hour
study period. Anthropometric measures such as weight, height and waist circumference will be
collected at screening and at the start of each test day. Thirteen hours before testing,
participants will eat a control meal to reduce variation in glycemic responses on test days
due to varying dietary intakes. This control meal will be selected by each participant before
the start of the study. They will be provided a gift card to the chain restaurant to use to
purchase their own meal. Since subjects serve as their own controls, the meals must be
identical before each test draw. Participants will complete 24 hour recall food records the
morning of each test day to provide information related to dietary protocol compliance.
apart. Participants will be required to consume the entire test treatment meal in 7 minutes
while being observed. All test foods will be purchased from local markets. Capillary blood
samples will be collected (~50µl) at time 0 (fasting) and at 30, 60, 90, 120 and 180 minutes
post-treatment (timing of the post-treatment blood draws started at time 0 [post-treatment],
which is when the participant finishes consuming the treatment meal). Venous blood draws for
insulin assessment will also be acquired at fasting and then every hour for the three hour
study period. Anthropometric measures such as weight, height and waist circumference will be
collected at screening and at the start of each test day. Thirteen hours before testing,
participants will eat a control meal to reduce variation in glycemic responses on test days
due to varying dietary intakes. This control meal will be selected by each participant before
the start of the study. They will be provided a gift card to the chain restaurant to use to
purchase their own meal. Since subjects serve as their own controls, the meals must be
identical before each test draw. Participants will complete 24 hour recall food records the
morning of each test day to provide information related to dietary protocol compliance.
Inclusion Criteria:
- 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%.
Exclusion Criteria:
- 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.
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