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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Metabolic Disease
• Intervention / Treatment: Other: Meal (Eating) Frequency; Other: Protein Composition

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Centre, Singapore

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases
• Other Study ID Numbers: 2015/01504