Clinical trial NCT01840982: The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
Official title: A Randomized, Crossover Clinical Trial, The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy People
Diabetes Mellitus, Type 2
Keywords: Mixed grains
Glycemic index
Giant embryonic brown rice
Giant embryonic rice
diabetes
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic index(GI) in healthy males.

Detailed description: After a 12-hour fast, oral glucose or meal tolerance test was performed with blood samples drawn at time 0, 15, 30, 45, 90, 120, 150, and 180 min.

1. Serum levels of glucose, insulin, and C-peptide were analyzed by biochemical autoanalyzer. The area under the curve (AUC) changes in blood glucose were computed by the trapezoidal method.
2. Glycemic index(GI): the area under the glucose response curve after consumption of a test food divided by the area under the curve after consumption of a control food containing the same amount of carbohydrate and calculated using 50 g glucose as the reference.

Eligibility criteria: Inclusion Criteria:

* Males, 19\~60years old
* Bodyweight was more than 50 kg with ideal body weight within ±30%
* Less than 100 mg/dl in fasting blood glucose and less than 140 mg/dl in an oral glucose tolerance test (OGTT)
* Able to give informed consent

Exclusion Criteria:

* Major medical illness such as cardiovascular, neurologic, psychiatric, renal, pulmonary and hepatic diseases
* History of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
* Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Poor vital sign (systolic blood pressure: below 100 mmHg or above 150 mmHg, diastolic blood pressure: below 65 mmHg or above95 mmHg)
* Allergic or hypersensitive to any of the ingredients in the test products; treated with any drug within past 2 weeks
* Participation in any other clinical trials within past 2 months
* Alcohol consumption above 21 units per week or abnormal screening laboratory test
* Being judged by the responsible physician of the local study center as unfit to participate in the study

Primary outcomes:
measure: 1. Glycemic index(GI) 2. Glucose, insulin AUC(incremental area under the curve) 3. C-peptide
timeFrame: 2 hour postprandial blood glucose, insulin, c-peptide
Secondary outcomes:
measure: Homeostatic model assessment-insulin resistance(HOMA-IR), quantitative insulin sensitivity check index(QUICKI), Insulinogenic index(IGI)
timeFrame: fasting and postprandial (different times for 30min)
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Soo-Wan Chae, MD., PhD
role: STUDY_DIRECTOR
References: