Pre DiabetesNCT03309254
Role of Glycaemic Index and High Protein Meal in Response of Blood Biomarkers for Pre-diabetes
A study testing High Glycemic Index and Low Glycemic Index in people with Pre Diabetes, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
This study aims to demonstrate the effectiveness of increased protein ingestion, particularly when coupled with a low glycaemic index (GI) to reduce biomarkers related to high risk of diabetes. Read more about this study
- Who is it for?
- Ages 23 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- High Glycemic Index and Low Glycemic Index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Jan 2016to 23 Mar 2018
- 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 23 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1: 55-70 years old, 5 years post-menopausal (a: healthy, b: fasting blood glucose, ≥5.1mmol/l) or
- Group 2: 23-54 years old (a: healthy, b: fasting blood glucose, ≥5.1mmol/l)
- Body mass index between 18 and 30 kg/m2
Who cannot join
- Have family history of diabetes or any major chronic disease such as diabetes, heart disease or cancer
- On prescribed medication known to affect blood glucose concentrations or major effects on body fat distribution
- Have allergic/intolerant to any of the test foods (e.g bread, turkey breast, almond, cashew, glucose, fructose and chamomile tea.
- Have gastrointestinal diseases that may interfere with digestion or nutrient absorption
- Have medical or surgical events requiring hospitalization within the preceding three months
- Currently pregnant or breastfeeding
- Have G6PD deficiency
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to demonstrate the effectiveness of increased protein ingestion, particularly when coupled with a low glycaemic index (GI) to reduce biomarkers related to high risk of diabetes.
Read the detailed description
A randomized cross-over study and subjects will be randomized to take either the high GI or low GI meal. The sequence of the meal will be generated using an online randomiser generator.During screening administer informed consent.Measure height, weight, waist and hip circumference.Blood draw: Two fingerpricks, 5 minutes apart. 1 X 10ml red tube top to prepare serum. Serum and red platelets into separate microtubes. Serum will be used to analyse fasting blood glucose, lipid profile, C-Reactive Protein (CPR), insulin and apolipoprotein. Red platelets will be stored separately for DNA genotyping. During the study visits,On Day 1, subjects will come to the Centre at around 4:00 pm to have the continuous glucose monitoring (CGMS) system inserted. CGMS will be used to measure 24 hour blood glucose concentrations. The sensor records interstitial blood glucose concentrations every five minutes. This will involve the insertion of a small sensor under the skin in the abdomen, which will be carried out by using a device that produces minimal pain and discomfort.Subjects will have to wait in the laboratory for one hour after insertion for the sensor to be stabilized. After one hour the inserted CGMS sensor will be calibrated against a manual finger-prick blood glucose sample.Manual calibration using finger-prick blood samples will need to be carried out before every meal and before bed in the night. The calibrations before dinner and bed will have to be carried out by the subjects at home.Therefore, the subjects will be provided with a finger-prick blood glucose test kit to take home and instructed on how to correctly use it and measure blood glucose values. Subjects will then consume the standardised dinner at around 7pm.Subjects will be asked to fast overnight and instructed to avoid eating or drinking anything, except water, after 10pm. Subjects will arrived between 8.00am and 8.30am the following morning. Baseline blood samples will be collected. A venous cannula will be inserted and a fasting blood sample collected. Baseline basal metabolic rate will be measured using hood-ventilated indirect calorimetry for 30mins during fasting. Subjects will then consume the test meal. Further venous blood samples will be collected at regular intervals for up to 4hours postprandial. After meal, subjects will enter the hood-ventilated indirect calorimetry and measure post-prandial respiratory quotient for 4 hours. A medium GI lunch will then be provided and the subject can either stay in the centre or return to the centre 4 hours after lunch to remove the CGMS.
- Conditions
- Pre Diabetes
- Being tested
- High Glycemic Index, Low Glycemic Index
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Glycemic IndexOther
High Glycemic Index Food
Low Glycemic IndexOther
Low Glycemic Index Food
| Study group | Role | What they receive |
|---|---|---|
| High Glycemic Index | Experimental | White Bread with Turkey breast meat (2 slices) Turkey Breast (7 slices) Chamomile Tea with 25 grams glucose Almonds 15 grams Receives: Other: High Glycemic Index |
| Low Glycemic Index | Experimental | Multi-grain Bread with Turkey breast meat (2 slices) Turkey Breast (6 slices) Chamomile Tea with 25 grams fructose Cashews 10 grams Receives: Other: Low Glycemic Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response
measured using continuous glucose monitoring system
Measured: up to 8 hours
Glycemic response
measured using COBAS Analyzer
Measured: up to 4 hours
Secondary outcomes (2)
Blood Biochemistry
measured using COBAS Analyzer
Measured: up to 4 hours
Respiratory quotient and fat oxidation
measured using indirect calorimeter
Measured: up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start18 Jan 2016
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
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 Pre DiabetesStudies 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 study
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- University of Auckland, New Zealand, Massey University, Riddet University
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309254
- Sponsor's protocol ID
- 2015/01077
- Other IDs
- 2015
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2017
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camps SG, Koh HR, Wang NX, Henry CJ. High fructose consumption with a high-protein meal is associated with decreased glycemia and increased thermogenesis but reduced fat oxidation: A randomized controlled trial. Nutrition. 2019 Feb;58:77-82. doi: 10.1016/j.nut.2018.06.024. Epub 2018 Jul 20.
PubMed 30391694
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Glycaemic Index and High Protein Meal in Response of Blood Biomarkers for Pre-diabetes
- ClinicalTrials.gov ID
- NCT03309254
- Acronym / sponsor ID
- 2015/01077
- Conditions
- Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- University of Auckland, New Zealand, Massey University, Riddet University
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 13 Oct 2017 (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.
This study aims to demonstrate the effectiveness of increased protein ingestion, particularly when coupled with a low glycaemic index (GI) to reduce biomarkers related to high risk of diabetes.
Detailed description
A randomized cross-over study and subjects will be randomized to take either the high GI or low GI meal. The sequence of the meal will be generated using an online randomiser generator.During screening administer informed consent.Measure height, weight, waist and hip circumference.Blood draw: Two fingerpricks, 5 minutes apart. 1 X 10ml red tube top to prepare serum. Serum and red platelets into separate microtubes. Serum will be used to analyse fasting blood glucose, lipid profile, C-Reactive Protein (CPR), insulin and apolipoprotein. Red platelets will be stored separately for DNA genotyping. During the study visits,On Day 1, subjects will come to the Centre at around 4:00 pm to have the continuous glucose monitoring (CGMS) system inserted. CGMS will be used to measure 24 hour blood glucose concentrations. The sensor records interstitial blood glucose concentrations every five minutes. This will involve the insertion of a small sensor under the skin in the abdomen, which will be carried out by using a device that produces minimal pain and discomfort.Subjects will have to wait in the laboratory for one hour after insertion for the sensor to be stabilized. After one hour the inserted CGMS sensor will be calibrated against a manual finger-prick blood glucose sample.Manual calibration using finger-prick blood samples will need to be carried out before every meal and before bed in the night. The calibrations before dinner and bed will have to be carried out by the subjects at home.Therefore, the subjects will be provided with a finger-prick blood glucose test kit to take home and instructed on how to correctly use it and measure blood glucose values. Subjects will then consume the standardised dinner at around 7pm.Subjects will be asked to fast overnight and instructed to avoid eating or drinking anything, except water, after 10pm. Subjects will arrived between 8.00am and 8.30am the following morning. Baseline blood samples will be collected. A venous cannula will be inserted and a fasting blood sample collected. Baseline basal metabolic rate will be measured using hood-ventilated indirect calorimetry for 30mins during fasting. Subjects will then consume the test meal. Further venous blood samples will be collected at regular intervals for up to 4hours postprandial. After meal, subjects will enter the hood-ventilated indirect calorimetry and measure post-prandial respiratory quotient for 4 hours. A medium GI lunch will then be provided and the subject can either stay in the centre or return to the centre 4 hours after lunch to remove the CGMS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover study
| Arm | Type | Receives |
|---|---|---|
| High Glycemic Index | Experimental | Other: High Glycemic IndexWhite Bread with Turkey breast meat (2 slices) Turkey Breast (7 slices) Chamomile Tea with 25 grams glucose Almonds 15 grams |
| Low Glycemic Index | Experimental | Other: Low Glycemic IndexMulti-grain Bread with Turkey breast meat (2 slices) Turkey Breast (6 slices) Chamomile Tea with 25 grams fructose Cashews 10 grams |
Who may qualify
- Ages
- 23 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Group 1: 55-70 years old, 5 years post-menopausal (a: healthy, b: fasting blood glucose, ≥5.1mmol/l) or
- Group 2: 23-54 years old (a: healthy, b: fasting blood glucose, ≥5.1mmol/l)
- Body mass index between 18 and 30 kg/m2
Key exclusion criteria (7 listed)
- Have family history of diabetes or any major chronic disease such as diabetes, heart disease or cancer
- On prescribed medication known to affect blood glucose concentrations or major effects on body fat distribution
- Have allergic/intolerant to any of the test foods (e.g bread, turkey breast, almond, cashew, glucose, fructose and chamomile tea.
- Have gastrointestinal diseases that may interfere with digestion or nutrient absorption
- Have medical or surgical events requiring hospitalization within the preceding three months
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 |
|---|---|---|
| High Glycemic IndexHigh Glycemic Index Food | Other | High Glycemic Index |
| Low Glycemic IndexLow Glycemic Index Food | Other | Low Glycemic Index |
Primary outcome
Glycemic response
Time frame: up to 8 hours
measured using continuous glucose monitoring system
Glycemic response
Time frame: up to 4 hours
measured using COBAS Analyzer
2 secondary outcomes
Blood Biochemistry
Time frame: up to 4 hours
Respiratory quotient and fat oxidation
Time frame: up to 4 hours
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 12 Oct 2018.
- Derived from this study: PubMed 30391694Camps SG, Koh HR, Wang NX, Henry CJ. High fructose consumption with a high-protein meal is associated with decreased glycemia and increased thermogenesis but reduced fat oxidation: A randomized controlled trial. Nutrition. 2019 Feb;58:77-82. doi: 10.1016/j.nut.2018.06.024. Epub 2018 Jul 20.
- Individual participant dataSharing planned: No
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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 High Glycemic Index and Low Glycemic Index in people with Pre Diabetes, 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 3 inclusion and 7 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 12 Oct 2018. 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 8 hours). 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 NCT03309254, 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 12 Oct 2018.