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

Primary Purpose

Metabolic Disease, Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Meal (Eating) Frequency
Protein Composition
Sponsored by
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Disease

Eligibility Criteria

21 Years - 40 Years (Adult)MaleAccepts 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    CON-2

    CON-6

    PRO-2

    PRO-6

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Venous Plasma Glucose
    Biochemical variable on a continuous scale.
    Venous Plasma Insulin
    Biochemical variable on a continuous scale.
    Venous Plasma Triglyceride
    Biochemical variable on a continuous scale.
    Blood Pressure
    Systolic and Diastolic Pressure measured in mmHg
    Interstitial Glucose
    Measured using a continuous glucose monitor.

    Secondary Outcome Measures

    Urinary F2 Isoprostanes
    Biochemical variable on a continuous scale.
    Subjective Appetite Ratings
    Measured on a 100mm Visual Analog Scale (VAS). 0mm=Not full at all, 100mm= Extremely full.

    Full Information

    First Posted
    August 17, 2015
    Last Updated
    August 18, 2015
    Sponsor
    Clinical Nutrition Research Centre, Singapore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02529228
    Brief Title
    Combined Effects of Meal Frequency and Protein Load on Cardiometabolic Risk Factors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clinical Nutrition Research Centre, Singapore

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Disease, Cardiovascular Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CON-2
    Arm Type
    Experimental
    Arm Description
    Consuming 2 Low Protein, High Carbohydrate Meals i.e. changing Meal Frequency and Protein Composition.
    Arm Title
    CON-6
    Arm Type
    Experimental
    Arm Description
    Dividing meal intake into 6 smaller Low Protein, High Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.
    Arm Title
    PRO-2
    Arm Type
    Experimental
    Arm Description
    Consuming 2 High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.
    Arm Title
    PRO-6
    Arm Type
    Experimental
    Arm Description
    Dividing meal intake into 6 smaller High Protein, Low Carbohydrate Meals. i.e. changing Meal Frequency and Protein Composition.
    Intervention Type
    Other
    Intervention Name(s)
    Meal (Eating) Frequency
    Intervention Description
    Dividing meal intake into 2 or 6 meals with equal energy content
    Intervention Type
    Other
    Intervention Name(s)
    Protein Composition
    Intervention Description
    Consuming meals with higher or lower protein.
    Primary Outcome Measure Information:
    Title
    Venous Plasma Glucose
    Description
    Biochemical variable on a continuous scale.
    Time Frame
    Postprandially 8.5 hours in response to the various diets
    Title
    Venous Plasma Insulin
    Description
    Biochemical variable on a continuous scale.
    Time Frame
    Postprandially 8.5 hours in response to the various diets
    Title
    Venous Plasma Triglyceride
    Description
    Biochemical variable on a continuous scale.
    Time Frame
    Postprandially 8.5 hours in response to the various diets
    Title
    Blood Pressure
    Description
    Systolic and Diastolic Pressure measured in mmHg
    Time Frame
    Postprandially 8.5 hours in response to the various diets
    Title
    Interstitial Glucose
    Description
    Measured using a continuous glucose monitor.
    Time Frame
    Postprandially 8.5 hours in response to the various diets
    Secondary Outcome Measure Information:
    Title
    Urinary F2 Isoprostanes
    Description
    Biochemical variable on a continuous scale.
    Time Frame
    Postprandially 8.5 hours in response to the various diets
    Title
    Subjective Appetite Ratings
    Description
    Measured on a 100mm Visual Analog Scale (VAS). 0mm=Not full at all, 100mm= Extremely full.
    Time Frame
    Postprandially 8.5 hours in response to the various diets

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26979583
    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.
    Results Reference
    derived

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

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