Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 52 of 3094 for:    Area Under Curve AND Healthy

The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01840982
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy People Diabetes Mellitus, Type 2 Dietary Supplement: Mixed grain 1 Dietary Supplement: Mixed grain 2 Dietary Supplement: White rice Other: Glucose solution Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Crossover Clinical Trial, The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
Study Start Date : October 2010
Actual Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Mixed grain 1(Giant embryonic brown rice ) Dietary Supplement: Mixed grain 1
All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.
Other Name: Mixed grain 1 (Giant embryonic brown rice) diet

Experimental: Mexed grain 2 (Giant embryonic rice ) Dietary Supplement: Mixed grain 2
All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.
Other Name: Mixed grain 2 (Giant embryonic rice) diet

Active Comparator: White rice Dietary Supplement: White rice
All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.
Other Name: control diet

Active Comparator: Glucose solution Other: Glucose solution
All test foods contained 50 g available carbohydrate from the test food products.
Other Name: Reference diet




Primary Outcome Measures :
  1. 1. Glycemic index(GI) 2. Glucose, insulin AUC(incremental area under the curve) 3. C-peptide [ Time Frame: 2 hour postprandial blood glucose, insulin, c-peptide ]
    1. Glycemic index (GI) was defined as 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. Plasma glucose will be measured at baseline, 15, 30, 45, 60, 90, and 120 minutes post ingestion of each test solution.

      GI= (incremental blood glucose area of test meal/incremental area of glucose) × 100

    2. Plasma glucose and insulin will be measured at baseline, 15, 30, 45, 60, 90, 120, 180 and 240 minutes post ingestion of each test solution, and area under the curve will be calculated.
    3. Plasma c-peptide will be measured at baseline, 120 minutes post ingestion of each test solution.


Secondary Outcome Measures :
  1. Homeostatic model assessment-insulin resistance(HOMA-IR), quantitative insulin sensitivity check index(QUICKI), Insulinogenic index(IGI) [ Time Frame: fasting and postprandial (different times for 30min) ]
    1. HOMA-IR={fasting insulin(µU/㎖) x fasting glucose(m㏖/L)}/22.5
    2. QUICKI=1/log(insulin 0min)-log(glucose 0min)
    3. IGI=(insulin 30min-fasting insulin)/(glucose 30min-fasting glucose)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840982


Locations
Layout table for location information
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Layout table for investigator information
Study Director: Soo-Wan Chae, MD., PhD Chonbuk National University Hospital

Layout table for additonal information
Responsible Party: Soo-Wan Chae, Director, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01840982     History of Changes
Other Study ID Numbers: CTCF2_2010_MC_2
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Soo-Wan Chae, Chonbuk National University Hospital:
Mixed grains
Glycemic index
Giant embryonic brown rice
Giant embryonic rice
diabetes

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases