- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02455765
Glycemic Response of Co-ingesting Carbohydrate and Amino Acids
January 27, 2016 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
The study will investigate if consumption of amino acid mixtures results a change in glycemic response of carbohydrate (white rice) and insulinemic response at different doses and timing (before consumption of carbohydrate).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Healthy male subjects will be served with amino acid mixtures in combinations of two doses and three time points along with white rice as control.
The combinations were either low or high levels of amino acid mixtures.
This was consumed together or 15 min, 30 min before consumption of white rice.
Postprandial blood glucose and plasma insulin concentrations were measured at fasting and every 15 min after consumption of treatment meal until 60 min after the consumption of white rice.
Subsequent blood sample were taken at 30 min interval until 210min.
The glucose and insulin in the blood will be analysed.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Chinese ethnicity
- Age between 21-50 years
- Body mass index (BMI) between 18-24.9 kg/m2
- Waist circumference ≤ 90 cm for men
- Normal blood pressure (<120/80 mmHg)
- Fasting blood glucose < 6 mmol/L
Exclusion Criteria:
- dislike the consumption of Essence of Chicken
- participating in competitive sports
- allergic to amino acids and rice
- metabolic diseases (such as diabetes, hypertension and the metabolic syndromes)
- Glucose-6-Phosphate-Dehydrogenase (G6PD) Deficiency
- on prescription medication
- smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: White rice control
Subjects will consume white rice as control (50g carbohydrate)
|
Rice and amino acid mixture
|
Experimental: co-ingest low dose of amino acid
Subjects will receive 68 ml of amino acid mixture together with white rice
|
Rice and amino acid mixture
|
Experimental: co-ingest high dose of amino acid
Subjects will receive 136 ml of amino acid mixture together with white rice
|
Rice and amino acid mixture
|
Experimental: pre-load low dose15 min
Subjects will receive 68 ml of amino acid mixture 15 min before consumption of white rice
|
Rice and amino acid mixture
|
Experimental: pre-load low dose 30 min
Subjects will receive 68 ml of amino acid mixture 30 min before consumption of white rice
|
Rice and amino acid mixture
|
Experimental: pre-load high dose 15 min
Subjects will receive 136 ml of amino acid mixture 15 min before consumption of white rice
|
Rice and amino acid mixture
|
Experimental: pre-load high dose 30 min
Subjects will receive 136 ml of amino acid mixture 30 min before consumption of white rice
|
Rice and amino acid mixture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic response
Time Frame: 210 minutes post consumption of carbohydrate
|
Blood glucose will be assessed via finger prick during fasting and every 15 minutes for the first 60 min after the consumption white rice and subsequently every 30 min interval until 210 min
|
210 minutes post consumption of carbohydrate
|
Insulinemic response
Time Frame: 210 minutes post consumption of carbohydrate
|
Plasma insulin will be assessed via finger prick during fasting and every 15 minutes for the first 60 min after the consumption white rice and subsequently every 30 min interval until 210 min
|
210 minutes post consumption of carbohydrate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
May 21, 2015
First Submitted That Met QC Criteria
May 25, 2015
First Posted (Estimate)
May 28, 2015
Study Record Updates
Last Update Posted (Estimate)
January 28, 2016
Last Update Submitted That Met QC Criteria
January 27, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/00366
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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