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

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529228
• Other study ID #: 2015/01504
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: August 18, 2015
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Disease
• Metabolic Diseases

Intervention

Other:
• Meal (Eating) Frequency
Dividing meal intake into 2 or 6 meals with equal energy content
• Protein Composition
Consuming meals with higher or lower protein.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous Plasma Glucose	Biochemical variable on a continuous scale.	Postprandially 8.5 hours in response to the various diets	No
Primary	Venous Plasma Insulin	Biochemical variable on a continuous scale.	Postprandially 8.5 hours in response to the various diets	No
Primary	Venous Plasma Triglyceride	Biochemical variable on a continuous scale.	Postprandially 8.5 hours in response to the various diets	No
Primary	Blood Pressure	Systolic and Diastolic Pressure measured in mmHg	Postprandially 8.5 hours in response to the various diets	No
Primary	Interstitial Glucose	Measured using a continuous glucose monitor.	Postprandially 8.5 hours in response to the various diets	No
Secondary	Urinary F2 Isoprostanes	Biochemical variable on a continuous scale.	Postprandially 8.5 hours in response to the various diets	No
Secondary	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	No