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

NCT ID: NCT02529228

Last Updated: 2015-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Metabolic Disease Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CON-2

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

Group Type EXPERIMENTAL

Meal (Eating) Frequency

Intervention Type OTHER

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

Protein Composition

Intervention Type OTHER

Consuming meals with higher or lower protein.

CON-6

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

Group Type EXPERIMENTAL

Meal (Eating) Frequency

Intervention Type OTHER

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

Protein Composition

Intervention Type OTHER

Consuming meals with higher or lower protein.

PRO-2

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

Group Type EXPERIMENTAL

Meal (Eating) Frequency

Intervention Type OTHER

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

Protein Composition

Intervention Type OTHER

Consuming meals with higher or lower protein.

PRO-6

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

Group Type EXPERIMENTAL

Meal (Eating) Frequency

Intervention Type OTHER

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

Protein Composition

Intervention Type OTHER

Consuming meals with higher or lower protein.

Interventions

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Meal (Eating) Frequency

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

Intervention Type OTHER

Protein Composition

Consuming meals with higher or lower protein.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Singapore Institute of Food and Biotechnology Innovation

OTHER_GOV

Sponsor Role lead

Responsible Party

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Melvin Leow

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 26979583 (View on PubMed)

Other Identifiers

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2015/01504

Identifier Type: -

Identifier Source: org_study_id

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