NCT02529228

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

August 17, 2015

Last Update Submit

August 18, 2015

Conditions

Metabolic DiseaseCardiovascular Disease

Outcome Measures

Primary Outcomes (5)

  • Venous Plasma Glucose

    Biochemical variable on a continuous scale.

    Postprandially 8.5 hours in response to the various diets

  • Venous Plasma Insulin

    Biochemical variable on a continuous scale.

    Postprandially 8.5 hours in response to the various diets

  • Venous Plasma Triglyceride

    Biochemical variable on a continuous scale.

    Postprandially 8.5 hours in response to the various diets

  • Blood Pressure

    Systolic and Diastolic Pressure measured in mmHg

    Postprandially 8.5 hours in response to the various diets

  • Interstitial Glucose

    Measured using a continuous glucose monitor.

    Postprandially 8.5 hours in response to the various diets

Secondary Outcomes (2)

  • Urinary F2 Isoprostanes

    Postprandially 8.5 hours in response to the various diets

  • Subjective Appetite Ratings

    Postprandially 8.5 hours in response to the various diets

Study Arms (4)

CON-2

EXPERIMENTAL

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

Other: Meal (Eating) FrequencyOther: Protein Composition

CON-6

EXPERIMENTAL

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

Other: Meal (Eating) FrequencyOther: Protein Composition

PRO-2

EXPERIMENTAL

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

Other: Meal (Eating) FrequencyOther: Protein Composition

PRO-6

EXPERIMENTAL

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

Other: Meal (Eating) FrequencyOther: Protein Composition

Interventions

Meal (Eating) FrequencyOTHER

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

CON-2CON-6PRO-2PRO-6
Protein CompositionOTHER

Consuming meals with higher or lower protein.

CON-2CON-6PRO-2PRO-6

Eligibility Criteria

Age21 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26979583DERIVED

MeSH Terms

Conditions

Metabolic DiseasesCardiovascular Diseases

Interventions

MealsEatingRFC3 protein, Arabidopsis

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesNutritional Physiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 20, 2015

Study Start

December 1, 2014

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

August 20, 2015

Record last verified: 2015-08