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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02380846
Other study ID # 2013/00589
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date October 8, 2018

Study information

Verified date May 2019
Source Clinical Nutrition Research Centre, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to find out how consuming different proteins with rice affect metabolism. Most meals the investigators eat predominantly consist of a carbohydrate and protein (i.e. rice, noodles, bread etc with meats or seafood). However, it is still unknown how consuming different proteins with commonly eaten carbohydrates affect metabolism. Previous studies have shown that proteins stimulate hormones such as insulin, glucagon and gut hormones. However, the extent of the response depends on protein type. The metabolic responses to carbohydrates have also been shown to be greatly affected when they are eaten with proteins. However, most of the previous studies have used glucose as the carbohydrate and it is still unknown how eating proteins with carbohydrate foods such as rice affect metabolism. Therefore, this study has been initiated to determine the metabolic effects of eating different protein types with rice. Using the most common carbohydrate eaten in Asia (rice) and four commonly eaten protein foods (egg, chicken, fish and beancurd), this study aims to observe the metabolic effects of co-ingesting proteins and carbohydrate. The resulting data will provide valuable insights into the metabolic effects of protein-carbohydrate meals and will be useful in the development of practical advice and dietary guidelines for those with chronic diseases (such as diabetes and obesity).


Description:

The study will recruit 20 healthy Chinese male subjects from the general public over a period of one year. The test foods will be rice, rice with egg, rice with fish, rice with chicken and rice with beancurd.Potential participants will have to come on one morning in an overnight fasted state for consenting and screening procedures. Only those fulfilling the inclusion and exclusion criteria will be admitted into the study. Each participant will be required to come on 5 non-consecutive days, with each session lasting approximately 4 hours. On each day, participants will arrive at the laboratory between 8-9 am following an overnight fast. An indwelling catheter will be inserted into a vein in their forearm or antecubital fossa and kept patent. Baseline blood samples will be obtained after which they will be given the test food to consume. Further blood samples will be taken at periodic intervals for the subsequent 3.5 hours. Blood samples will be taken every 15 minutes in the first 60 minutes and every 30 minutes for the remaining 150 minutes. At every time point blood samples will be extracted from a finger prick (for measuring glucose) and from the cannula (for measuring all other metabolites). At the same time points subjects will have to fill in visual analogue scales on feelings of hunger and satiety.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date October 8, 2018
Est. primary completion date October 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 40 Years
Eligibility Inclusion Criteria:

- Chinese ethnicity

- Male

- Age between 21-40 years

- Do not have any metabolic diseases (diabetes, hypertension etc)

- Do not have G6PD deficiency

- Not on prescription medication known to affect glucose related metabolism

- Not allergic/intolerant to any of the test foods

- Do not partake in sports at the competitive and/or endurance levels

- Weight of at least 45kg

- Body mass index between 18.0 to 24.9 kg/m2

- Normal blood pressure (120/80 mmHg)

- Fasting blood glucose <6.0 mmol/L

Study Design


Related Conditions & MeSH terms


Intervention

Other:
White rice
Control - white rice
Rice with chicken breast
Treatment 1 - steamed white rice with steamed chicken breast
Rice with fish
Treatment 2 - steamed white rice with steamed fish
Rice with egg white
Treatment 3 - steamed white rice with egg white
Rice with beancurd
Treatment 4 - steamed white rice with steamed beancurd

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Clinical Nutrition Research Centre, Singapore

Outcome

Type Measure Description Time frame Safety issue
Primary Blood glucose response (incremental area under the curve) measured using the hemocue Blood glucose response (incremental area under the curve) measured using the hemocue 3.5 hours post consumption
Primary Insulin (incremental area under the curve) is determined using the COBAS Insulin (incremental area under the curve) is determined using the COBAS 3.5 hours post consumption
Primary Glucagon determined using the ELISA Glucagon is determined using the ELISA 3.5 hours post consumption
Secondary Effects of physical activity Self-reported evaluation of physical activity according to a qualitative scale: light, medium or strenuous exercise done the day before the study visit. Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.
Secondary Satiety: Hunger and fullness measured using the Visual analogue scale Hunger and fullness measured using the Visual Analogue Scale Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.
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