Clinical trial NCT02529228: Combined Effects of Meal Frequency and Protein Load on Cardiometabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disease
Cardiovascular Disease
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2015-08-20
Enrollment: 10
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Venous Plasma Glucose
timeFrame: Postprandially 8.5 hours in response to the various diets
measure: Venous Plasma Insulin
timeFrame: Postprandially 8.5 hours in response to the various diets
measure: Venous Plasma Triglyceride
timeFrame: Postprandially 8.5 hours in response to the various diets
measure: Blood Pressure
timeFrame: Postprandially 8.5 hours in response to the various diets
measure: Interstitial Glucose
timeFrame: Postprandially 8.5 hours in response to the various diets
Secondary outcomes:
measure: Urinary F2 Isoprostanes
timeFrame: Postprandially 8.5 hours in response to the various diets
measure: Subjective Appetite Ratings
timeFrame: Postprandially 8.5 hours in response to the various diets
Other outcomes:
Locations:
Study officials:
References:
citation: 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.