NCT02455765

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

May 21, 2015

Last Update Submit

January 27, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Glycemic response

    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

    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

Study Arms (7)

White rice control

EXPERIMENTAL

Subjects will consume white rice as control (50g carbohydrate)

Other: Rice and Amino Acid mixtures

co-ingest low dose of amino acid

EXPERIMENTAL

Subjects will receive 68 ml of amino acid mixture together with white rice

Other: Rice and Amino Acid mixtures

co-ingest high dose of amino acid

EXPERIMENTAL

Subjects will receive 136 ml of amino acid mixture together with white rice

Other: Rice and Amino Acid mixtures

pre-load low dose15 min

EXPERIMENTAL

Subjects will receive 68 ml of amino acid mixture 15 min before consumption of white rice

Other: Rice and Amino Acid mixtures

pre-load low dose 30 min

EXPERIMENTAL

Subjects will receive 68 ml of amino acid mixture 30 min before consumption of white rice

Other: Rice and Amino Acid mixtures

pre-load high dose 15 min

EXPERIMENTAL

Subjects will receive 136 ml of amino acid mixture 15 min before consumption of white rice

Other: Rice and Amino Acid mixtures

pre-load high dose 30 min

EXPERIMENTAL

Subjects will receive 136 ml of amino acid mixture 30 min before consumption of white rice

Other: Rice and Amino Acid mixtures

Interventions

Rice and amino acid mixture

White rice controlco-ingest high dose of amino acidco-ingest low dose of amino acidpre-load high dose 15 minpre-load high dose 30 minpre-load low dose 30 minpre-load low dose15 min

Eligibility Criteria

Age21 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2015

First Posted

May 28, 2015

Study Start

June 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01