Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus

NCT01241253 | Completed Phase 2

• 1 other identifier: NTS0020
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Glucose; Type 2 Diabetes Mellitus

Keywords

legumes; glycemic response; glucose; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Net blood glucose changes over time

  Capillary blood samples were collected via fingerstick using Safe-T-Fill® Lithium Heparin Mini Capillary Collection 125µl tubes (RAM Scientific, Yonkers, NY). Whole blood samples were analyzed for glucose content using the Yellow Springs Instrument Stat Plus Analyzer (YSI Life Sciences, Yellow Springs, OH) immediately after blood collection.

  fasting baseline glucose at time 0, then 30, 60, 90, 120, 150, and 180 minutes postprandial

Study Arms (1)

Cross-over study

NO INTERVENTION

beans and rice in a 50 gram carbohydrate dose

Other: Whole cooked beans with rice meals

Interventions

Whole cooked beans with rice meals OTHER

Three types of bean-and-rice meals all equal to 50 grams available CHO. Control treatment was 50 grams available CHO in the form of white rice alone.

Also known as: Bush Brothers & Company brand canned beans

Cross-over study

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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%.

Sponsors & Collaborators

• Arizona State University: lead
• United States Dry Bean Council: collaborator

Study Sites (1)

Arizona State University, Nutrition Program

Mesa, Arizona, 85212, United States

Location

Related Publications (3)

• Thompson SV, Winham DM, Hutchins AM. Bean and rice meals reduce postprandial glycemic response in adults with type 2 diabetes: a cross-over study. Nutr J. 2012 Apr 11;11:23. doi: 10.1186/1475-2891-11-23.

  PMID: 22494488 RESULT

• Hutchins AM, Winham DM, Thompson SV. Phaseolus beans: impact on glycaemic response and chronic disease risk in human subjects. Br J Nutr. 2012 Aug;108 Suppl 1:S52-65. doi: 10.1017/S0007114512000761.

  PMID: 22916816 RESULT

• Winham DM, Hutchins AM, Thompson SV. Glycemic Response to Black Beans and Chickpeas as Part of a Rice Meal: A Randomized Cross-Over Trial. Nutrients. 2017 Oct 4;9(10):1095. doi: 10.3390/nu9101095.

  PMID: 28976933 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Flour

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Donna M Winham, DrPH

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Outside Consultant

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 16, 2010
• Study Start: November 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

US (1)