Combined Effects of Meal Frequency and Protein Load on Cardiometabolic Risk Factors

Study Overview
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Brief Summary
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This study examines the effect of meal frequency and meal composition on risk factors of cardiometabolic disease.

Detailed Description
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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
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Metabolic Disease, Cardiovascular Disease

Intervention / Treatment
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* Other: Meal (Eating) Frequency
* Other: Protein Composition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CON-2<br>Consuming 2 Low Protein, High Carbohydrate Meals i.e. changing Meal Frequency and Protein Composition. | Other: Meal (Eating) Frequency<br>* Dividing meal intake into 2 or 6 meals with equal energy content<br>Other: Protein Composition<br>* Consuming meals with higher or lower protein.<br>|
| Experimental: CON-6<br>Dividing meal intake into 6 smaller Low Protein, High Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition. | Other: Meal (Eating) Frequency<br>* Dividing meal intake into 2 or 6 meals with equal energy content<br>Other: Protein Composition<br>* Consuming meals with higher or lower protein.<br>|
| Experimental: PRO-2<br>Consuming 2 High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition. | Other: Meal (Eating) Frequency<br>* Dividing meal intake into 2 or 6 meals with equal energy content<br>Other: Protein Composition<br>* Consuming meals with higher or lower protein.<br>|
| Experimental: PRO-6<br>Dividing meal intake into 6 smaller High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition. | Other: Meal (Eating) Frequency<br>* Dividing meal intake into 2 or 6 meals with equal energy content<br>Other: Protein Composition<br>* Consuming meals with higher or lower protein.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Plasma Glucose | Biochemical variable on a continuous scale. | Postprandially 8.5 hours in response to the various diets | 
| Venous Plasma Insulin | Biochemical variable on a continuous scale. | Postprandially 8.5 hours in response to the various diets | 
| Venous Plasma Triglyceride | Biochemical variable on a continuous scale. | Postprandially 8.5 hours in response to the various diets | 
| Blood Pressure | Systolic and Diastolic Pressure measured in mmHg | Postprandially 8.5 hours in response to the various diets | 
| Interstitial Glucose | Measured using a continuous glucose monitor. | Postprandially 8.5 hours in response to the various diets | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary F2 Isoprostanes | Biochemical variable on a continuous scale. | 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. | Postprandially 8.5 hours in response to the various diets |