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Completed

NCT Number: NCT02529228

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.

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Key information

Age range

21 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Meal (Eating) Frequency

Other

Dividing meal intake into 2 or 6 meals with equal energy content

Protein Composition

Other

Consuming meals with higher or lower protein.

Primary outcomes

  1. Venous Plasma Glucose

    Time frame: Postprandially 8.5 hours in response to the various diets

    Biochemical variable on a continuous scale.

  2. Venous Plasma Insulin

    Time frame: Postprandially 8.5 hours in response to the various diets

    Biochemical variable on a continuous scale.

  3. Venous Plasma Triglyceride

    Time frame: Postprandially 8.5 hours in response to the various diets

    Biochemical variable on a continuous scale.

  4. Blood Pressure

    Time frame: Postprandially 8.5 hours in response to the various diets

    Systolic and Diastolic Pressure measured in mmHg

  5. Interstitial Glucose

    Time frame: Postprandially 8.5 hours in response to the various diets

    Measured using a continuous glucose monitor.

Secondary outcomes

  1. Urinary F2 Isoprostanes

    Time frame: Postprandially 8.5 hours in response to the various diets

    Biochemical variable on a continuous scale.

  2. Subjective Appetite Ratings

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2015
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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