Effects of Food Sequence on the Glycaemic and Insulinaemic Responses

July 16, 2020 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
The study hypothesizes that vegetable and protein consumed before a carbohydrate will reduce the glucose response. The vegetables and protein consumed before carbohydrate have different effects on insulin and satiety responses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Up to 20 healthy subjects will be recruited for the study and before inclusion in the study, potential participants will be given the opportunity to ask questions. Subjects who will fulfill all the acceptable criteria(Chinese ethnicity, body mass index between 18-25 kg/m2, weight of at least 45kg, normal blood pressure,less than or equal 140 and 90 mmHg; age between 21-40 years, fasting blood glucose less than 6 mmol/L) may be included in the study.Each subject will be asked to complete a screening session(lasting approximately1 hour) in a fasted state where baseline measurements including anthropometric measurements, fasting blood glucose and blood pressure will be collected from each participant to assess their eligibility.On the day before each test, enrolled subjects will be asked to restrict their intake of alcohol and caffeine-containing drinks and to restrict their participation in intense physical activity (eg, long periods at the gym, intensive swimming, running, aerobics etc). There is a total of five test sessions. Test sessions will be interspaced by a minimum of 1 week. For each session, subjects are required to come between 8:00-9:00am, with each session lasting approximately 4 hours. Subjects would have to come following a 10-12 hour overnight fast. An indwelling catheter will be inserted into a vein in your forearm and will be kept patent (free of clots) for the remainder of the test session. The investigators will then take a blood sample from the cannula to measure baseline values. The investigators will also take a finger prick blood sample to measure blood glucose concentration. After obtaining the baseline blood samples the investigators will give subjects the test meal in different sequence consume in 15 minutes. Following the meal we will take further blood samples (from the cannula and finger pricks) for the next 15, 30, 45, 60, 90, 120, 150 and180 minutes. The amount of blood that will be collected at every time point will be about1.2 teaspoon of blood (approximately 6 mL).At the same time intervals the subjects will be instructed to fill in visual analogue scales on feelings of fullness, hunger, desire to eat and prospective food consumption.Visual analogue scales are 100 mm continuous lines anchored with opposing answers to a specific question asked. The specific questions asked will be, 'How hungry do you feel?', 'How full do you feel?', 'How strong is your desire to eat?', ' How much more food do you think you can eat?'. The subjects will be instructed to make a mark on the line which corresponds with their subjective feeling. After 3 hours, the cannula will be removed and the subjects will be instructed to an ad libitum lunch. After finish the lunch, the subjects will also be asked to complete a visual analogue scales (VAS) for the measurement of hunger and feelings of fullness. After which,subjects are free to leave Clinical Nutrition Research Centre. During the entire testing period the subjects will be instructed to remain rested and in the laboratory.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chinese ethnicity
  • Age between 21-40 years
  • Weight of at least 45 kg
  • Body mass index between 18 to 25 kg/m2
  • Normal blood pressure (≤140/90 mmHg)
  • Fasting blood glucose <6.0 mmol/L

Exclusion Criteria:

  • Are a female who is pregnant
  • Partake in sports at the competitive and/or endurance levels
  • Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Have major chronic disease such as heart disease, cancer or diabetes mellitus
  • Take insulin or drugs known to affect glucose metabolism
  • Intentionally restrict food intake
  • Have major medical or surgical event requiring hospitalization within the preceding 3 months
  • Have taken antibiotics for 3 months before the study period
  • Are a smoker
  • Are an overnight shift worker
  • Have any known food allergy (example anaphylaxis to peanuts)
  • Having active Tuberculosis (TB) or currently receiving treatment for TB
  • Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV).
  • Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  • Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC
  • Have poor veins impeding venous access
  • Have any history of severe vasovagal syncope blackouts or near faints following blood draws

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Food selection 1
To consume vegetables followed by meat & rice together
Other: Food sequence 1
Vegetables first then meat & rice together
Experimental: Food selection 2
To consume meat followed by vegetables & rice together
Other: Food sequence 2
Meat first then vegetables & rice together
Experimental: Food selection 3
To consume as follows: vegetables, meat, rice
Other: Food sequence 3
Vegetables first then meat followed by rice
Experimental: Food selection 4
To consume vegetables followed by meat and rice together
Other: Food sequence 4
Vegetables first followed by meat and rice together
Experimental: Food selection 5
To consume rice followed by vegetables & meat together
Other: Food sequence 5
Rice first followed by vegetables & meat together

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
glycemic response
Time Frame: up to 180 minutes
using Hemocue analyzer
up to 180 minutes
Insulin response
Time Frame: up to 180 minutes
using COBAS Analyzer
up to 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Nutrition Research Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/00742

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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