Clinical trial NCT02380846: The Metabolic Effects of Consuming Carbohydrate With Different Protein Types
Official title: The Metabolic Effects of Consuming Carbohydrate With Different Protein Types
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2015-03-05
Enrollment: 15
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose response (incremental area under the curve) measured using the hemocue
timeFrame: 3.5 hours post consumption
measure: Insulin (incremental area under the curve) is determined using the COBAS
timeFrame: 3.5 hours post consumption
measure: Glucagon determined using the ELISA
timeFrame: 3.5 hours post consumption
Secondary outcomes:
measure: Effects of physical activity
timeFrame: Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.
measure: Satiety: Hunger and fullness measured using the Visual analogue scale
timeFrame: Assessed at the start of every test session 1-2 weekly and up to 8 weeks in total per subject.
Other outcomes:
Locations:
Study officials:
References: