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

Clinical Nutrition Research Centre, Singapore

Status: Completed

Conditions: Metabolic Disease; Cardiovascular Disease

Treatments: Other: Protein Composition; Other: Meal (Eating) Frequency

Study type: Interventional

Funder types: Other

Identifiers

NCT02529228

2015/01504

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

CON-2

Experimental group

Description:

Consuming 2 Low Protein, High Carbohydrate Meals i.e. changing Meal Frequency and Protein Composition.

Treatment:

Other: Meal (Eating) Frequency

Other: Protein Composition

CON-6

Experimental group

Description:

Dividing meal intake into 6 smaller Low Protein, High Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.

Treatment:

Other: Meal (Eating) Frequency

Other: Protein Composition

PRO-2

Experimental group

Description:

Consuming 2 High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.

Treatment:

Other: Meal (Eating) Frequency

Other: Protein Composition

PRO-6

Experimental group

Description:

Dividing meal intake into 6 smaller High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.

Treatment:

Other: Meal (Eating) Frequency

Other: Protein Composition