Metabolic DiseaseNCT02529228
Combined Effects of Meal Frequency and Protein Load on Cardiometabolic Risk Factors
A study testing Meal (Eating) Frequency and Protein Composition in people with Metabolic Disease and Cardiovascular Disease, run by Singapore Institute of Food and Biotechnology Innovation.
Trial summary
This study examines the effect of meal frequency and meal composition on risk factors of cardiometabolic disease. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Cardiovascular Disease
- What is being tested?
- Meal (Eating) Frequency and Protein Composition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Aug 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese Males
- Age: 21 - 50 years.
- Body mass stable within the last 2 months by self-report.
- Body mass index (BMI): < 30kg/m2.
- Normal fasting blood glucose level≤ 6.0 mmol/L
- Blood pressure ≤ 140/90 mmHg
- Not participating in any dietary interventions in the past 2-months.
Who cannot join
- Special dietary practice (e.g. Vegetarians, Atkins diet) or diets due to religious reasons during the study period (e.g. Fasting for Ramadan)
- Smoking.
- Excessive alcohol consumption: consuming alcohol on >4 days per week with ≥5 alcoholic drinks (males) and ≥4 alcoholic drinks (females) per time (National Health Survey, 2010).
- Metabolic Diseases (including thyroid dysfunction)
- Using Medication affecting carbohydrate and fat metabolism
- Allergy to any components of the provided meals (gluten, nuts, milk, dairy)
About this study
This study examines the effect of meal frequency and meal composition on risk factors of cardiometabolic disease.
Read the detailed description
Cardio-Metabolic Disease (CMD) is the leading cause of death globally \& in Singapore. Large scale epidemiological evidence confirmed that elevated postprandial Glucose, Insulin, Triglycerides are major risk factors for CMD. Recent evidence suggests benefits from high protein diets but the health effects of eating smaller meals remain enigmatic. The aim of this study is to examine Meal frequency (2-large vs 6-smaller isocaloric meals), under High or Low Protein loads on acute postprandial health biomarkers . The investigators hypothesized that Higher Protein \& Higher Meal Frequency would be beneficial for cardiometabolic health.
- Conditions
- Metabolic Disease, Cardiovascular Disease
- Being tested
- Meal (Eating) Frequency, Protein Composition
- Medical subject headings
- Metabolic Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal (Eating) FrequencyOther
Dividing meal intake into 2 or 6 meals with equal energy content
Protein CompositionOther
Consuming meals with higher or lower protein.
| Study group | Role | What they receive |
|---|---|---|
| CON-2 | Experimental | Consuming 2 Low Protein, High Carbohydrate Meals i.e. changing Meal Frequency and Protein Composition. Receives: Other: Meal (Eating) Frequency; Other: Protein Composition |
| CON-6 | Experimental | Dividing meal intake into 6 smaller Low Protein, High Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition. Receives: Other: Meal (Eating) Frequency; Other: Protein Composition |
| PRO-2 | Experimental | Consuming 2 High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition. Receives: Other: Meal (Eating) Frequency; Other: Protein Composition |
| PRO-6 | Experimental | Dividing meal intake into 6 smaller High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition. Receives: Other: Meal (Eating) Frequency; Other: Protein Composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Plasma Glucose
Biochemical variable on a continuous scale.
Measured: Postprandially 8.5 hours in response to the various diets
Venous Plasma Insulin
Biochemical variable on a continuous scale.
Measured: Postprandially 8.5 hours in response to the various diets
Venous Plasma Triglyceride
Biochemical variable on a continuous scale.
Measured: Postprandially 8.5 hours in response to the various diets
Blood Pressure
Systolic and Diastolic Pressure measured in mmHg
Measured: Postprandially 8.5 hours in response to the various diets
Interstitial Glucose
Measured using a continuous glucose monitor.
Measured: Postprandially 8.5 hours in response to the various diets
Secondary outcomes (2)
Urinary F2 Isoprostanes
Biochemical variable on a continuous scale.
Measured: Postprandially 8.5 hours in response to the various diets
Subjective Appetite Ratings
Measured on a 100mm Visual Analog Scale (VAS). 0mm=Not full at all, 100mm= Extremely full.
Measured: Postprandially 8.5 hours in response to the various diets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionAug 2015
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 Metabolic DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Melvin Leow, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529228
- Sponsor's protocol ID
- 2015/01504
- Other IDs
- 2015
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mok A, Haldar S, Lee JC, Leow MK, Henry CJ. Postprandial changes in cardiometabolic disease risk in young Chinese men following isocaloric high or low protein diets, stratified by either high or low meal frequency - a randomized controlled crossover trial. Nutr J. 2016 Mar 15;15:27. doi: 10.1186/s12937-016-0141-5.
PubMed 26979583
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Meal Frequency and Protein Load on Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT02529228
- Acronym / sponsor ID
- 2015/01504
- Conditions
- Metabolic Disease, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Aug 2015 (estimated)
- 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 examines the effect of meal frequency and meal composition on risk factors of cardiometabolic disease.
Detailed description
Cardio-Metabolic Disease (CMD) is the leading cause of death globally \& in Singapore. Large scale epidemiological evidence confirmed that elevated postprandial Glucose, Insulin, Triglycerides are major risk factors for CMD. Recent evidence suggests benefits from high protein diets but the health effects of eating smaller meals remain enigmatic. The aim of this study is to examine Meal frequency (2-large vs 6-smaller isocaloric meals), under High or Low Protein loads on acute postprandial health biomarkers . The investigators hypothesized that Higher Protein \& Higher Meal Frequency would be beneficial for cardiometabolic health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CON-2 | Experimental | Other: Meal (Eating) Frequency, Other: Protein CompositionConsuming 2 Low Protein, High Carbohydrate Meals i.e. changing Meal Frequency and Protein Composition. |
| CON-6 | Experimental | Other: Meal (Eating) Frequency, Other: Protein CompositionDividing meal intake into 6 smaller Low Protein, High Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition. |
| PRO-2 | Experimental | Other: Meal (Eating) Frequency, Other: Protein CompositionConsuming 2 High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition. |
| PRO-6 | Experimental | Other: Meal (Eating) Frequency, Other: Protein CompositionDividing meal intake into 6 smaller High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Chinese Males
- Age: 21 - 50 years.
- Body mass stable within the last 2 months by self-report.
- Body mass index (BMI): < 30kg/m2.
- Normal fasting blood glucose level≤ 6.0 mmol/L
Key exclusion criteria (6 listed)
- Special dietary practice (e.g. Vegetarians, Atkins diet) or diets due to religious reasons during the study period (e.g. Fasting for Ramadan)
- Smoking.
- Excessive alcohol consumption: consuming alcohol on >4 days per week with ≥5 alcoholic drinks (males) and ≥4 alcoholic drinks (females) per time (National Health Survey, 2010).
- Metabolic Diseases (including thyroid dysfunction)
- Using Medication affecting carbohydrate and fat 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 |
|---|---|---|
| Meal (Eating) FrequencyDividing meal intake into 2 or 6 meals with equal energy content | Other | CON-2, CON-6, PRO-2, PRO-6 |
| Protein CompositionConsuming meals with higher or lower protein. | Other | CON-2, CON-6, PRO-2, PRO-6 |
Primary outcome
Venous Plasma Glucose
Time frame: Postprandially 8.5 hours in response to the various diets
Biochemical variable on a continuous scale.
Venous Plasma Insulin
Time frame: Postprandially 8.5 hours in response to the various diets
Biochemical variable on a continuous scale.
Venous Plasma Triglyceride
Time frame: Postprandially 8.5 hours in response to the various diets
Biochemical variable on a continuous scale.
Blood Pressure
Time frame: Postprandially 8.5 hours in response to the various diets
Systolic and Diastolic Pressure measured in mmHg
Interstitial Glucose
Time frame: Postprandially 8.5 hours in response to the various diets
Measured using a continuous glucose monitor.
2 secondary outcomes
Urinary F2 Isoprostanes
Time frame: Postprandially 8.5 hours in response to the various diets
Subjective Appetite Ratings
Time frame: Postprandially 8.5 hours in response to the various diets
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 20 Aug 2015.
- Derived from this study: PubMed 26979583Mok A, Haldar S, Lee JC, Leow MK, Henry CJ. Postprandial changes in cardiometabolic disease risk in young Chinese men following isocaloric high or low protein diets, stratified by either high or low meal frequency - a randomized controlled crossover trial. Nutr J. 2016 Mar 15;15:27. doi: 10.1186/s12937-016-0141-5.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Meal (Eating) Frequency and Protein Composition in people with Metabolic Disease and Cardiovascular Disease, run by Singapore Institute of Food and Biotechnology Innovation.
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 7 inclusion and 6 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 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Venous Plasma Glucose (time frame: Postprandially 8.5 hours in response to the various diets). The study lists 5 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 NCT02529228, 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 20 Aug 2015.