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

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ClinicalTrials.gov Identifier: NCT01840982
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Tracking Information
First Submitted Date  ICMJE April 5, 2013
First Posted Date  ICMJE April 26, 2013
Last Update Posted Date August 7, 2019
Study Start Date  ICMJE October 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01840982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2013)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
Official Title  ICMJE A Randomized, Crossover Clinical Trial, The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy People
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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
  • 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
  • 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
  • Other: Glucose solution
    All test foods contained 50 g available carbohydrate from the test food products.
    Other Name: Reference diet
Study Arms  ICMJE
  • Experimental: Giant embryonic brown rice
    Intervention: Dietary Supplement: Mixed grain 1
  • Experimental: Giant embryonic rice
    Intervention: Dietary Supplement: Mixed grain 2
  • Active Comparator: White rice
    Intervention: Dietary Supplement: White rice
  • Active Comparator: Glucose solution
    Intervention: Other: Glucose solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2013)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 25, 2015
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01840982
Other Study ID Numbers  ICMJE CTCF2_2010_MC_2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soo-Wan Chae, Chonbuk National University Hospital
Study Sponsor  ICMJE Chonbuk National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Soo-Wan Chae, MD., PhD Chonbuk National University Hospital
PRS Account Chonbuk National University Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP