Diabetes MellitusNCT03533738
Effects of Food Sequence on the Glycaemic and Insulinaemic Responses
A study testing Food sequence 1, Food sequence 2 and Food sequence 3 in people with Diabetes Mellitus and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Obesity
- What is being tested?
- Food sequence 1, Food sequence 2 and Food sequence 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Oct 2017to 17 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Obesity
- Being tested
- Food sequence 1, Food sequence 2, Food sequence 3, Food sequence 4, Food sequence 5
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food sequence 1Other
Vegetables first then meat \& rice together
Food sequence 2Other
Meat first then vegetables \& rice together
Food sequence 3Other
Vegetables first then meat followed by rice
Food sequence 4Other
Vegetables first followed by meat and rice together
Food sequence 5Other
Rice first followed by vegetables \& meat together
| Study group | Role | What they receive |
|---|---|---|
| Food selection 1 | Experimental | To consume vegetables followed by meat \& rice together Receives: Other: Food sequence 1 |
| Food selection 2 | Experimental | To consume meat followed by vegetables \& rice together Receives: Other: Food sequence 2 |
| Food selection 3 | Experimental | To consume as follows: vegetables, meat, rice Receives: Other: Food sequence 3 |
| Food selection 4 | Experimental | To consume vegetables followed by meat and rice together Receives: Other: Food sequence 4 |
| Food selection 5 | Experimental | To consume rice followed by vegetables \& meat together Receives: Other: Food sequence 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic response
using Hemocue analyzer
Measured: up to 180 minutes
Insulin response
using COBAS Analyzer
Measured: up to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start12 Oct 2017
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized crossover design
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533738
- Sponsor's protocol ID
- 2017/00742
- Other IDs
- 2017
- Status last verified
- May 2019
- First submitted
- 11 May 2018
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun L, Goh HJ, Govindharajulu P, Leow MK, Henry CJ. Postprandial glucose, insulin and incretin responses differ by test meal macronutrient ingestion sequence (PATTERN study). Clin Nutr. 2020 Mar;39(3):950-957. doi: 10.1016/j.clnu.2019.04.001. Epub 2019 Apr 27.
PubMed 31053510
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Food Sequence on the Glycaemic and Insulinaemic Responses
- ClinicalTrials.gov ID
- NCT03533738
- Acronym / sponsor ID
- 2017/00742
- Conditions
- Diabetes Mellitus, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Food selection 1 | Experimental | Other: Food sequence 1To consume vegetables followed by meat \& rice together |
| Food selection 2 | Experimental | Other: Food sequence 2To consume meat followed by vegetables \& rice together |
| Food selection 3 | Experimental | Other: Food sequence 3To consume as follows: vegetables, meat, rice |
| Food selection 4 | Experimental | Other: Food sequence 4To consume vegetables followed by meat and rice together |
| Food selection 5 | Experimental | Other: Food sequence 5To consume rice followed by vegetables \& meat together |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food sequence 1Vegetables first then meat \& rice together | Other | Food selection 1 |
| Food sequence 2Meat first then vegetables \& rice together | Other | Food selection 2 |
| Food sequence 3Vegetables first then meat followed by rice | Other | Food selection 3 |
| Food sequence 4Vegetables first followed by meat and rice together | Other | Food selection 4 |
| Food sequence 5Rice first followed by vegetables \& meat together | Other | Food selection 5 |
Primary outcome
glycemic response
Time frame: up to 180 minutes
using Hemocue analyzer
Insulin response
Time frame: up to 180 minutes
using COBAS Analyzer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Derived from this study: PubMed 31053510Sun L, Goh HJ, Govindharajulu P, Leow MK, Henry CJ. Postprandial glucose, insulin and incretin responses differ by test meal macronutrient ingestion sequence (PATTERN study). Clin Nutr. 2020 Mar;39(3):950-957. doi: 10.1016/j.clnu.2019.04.001. Epub 2019 Apr 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food sequence 1, Food sequence 2 and Food sequence 3 in people with Diabetes Mellitus and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic response (time frame: up to 180 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.