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

Not Applicable

Completed

• Conditions: Metabolic Disease; Cardiovascular Disease
• Interventions: Other: Meal (Eating) Frequency; Other: Protein Composition

• Registration Number: NCT02529228
• Lead Sponsor: Clinical Nutrition Research Centre, Singapore

Brief Summary

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 Timeline

• Study Start: 2014-12
• Primary Completion: 2015-05
• Status Verified: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-18
• Last Update Submitted: 2015-08-18
• Study First Posted: 2015-08-20
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CON-2	Protein Composition	Consuming 2 Low Protein, High Carbohydrate Meals i.e. changing Meal Frequency and Protein Composition.
CON-6	Meal (Eating) Frequency	Dividing meal intake into 6 smaller Low Protein, High Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.
CON-6	Protein Composition	Dividing meal intake into 6 smaller Low Protein, High Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.
PRO-2	Protein Composition	Consuming 2 High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.
PRO-2	Meal (Eating) Frequency	Consuming 2 High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.
PRO-6	Meal (Eating) Frequency	Dividing meal intake into 6 smaller High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.
PRO-6	Protein Composition	Dividing meal intake into 6 smaller High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.
CON-2	Meal (Eating) Frequency	Consuming 2 Low Protein, High Carbohydrate Meals i.e. changing Meal Frequency and Protein Composition.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Urinary F2 Isoprostanes	Postprandially 8.5 hours in response to the various diets	Biochemical variable on a continuous scale.
Subjective Appetite Ratings	Postprandially 8.5 hours in response to the various diets	Measured on a 100mm Visual Analog Scale (VAS). 0mm=Not full at all, 100mm= Extremely full.