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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02529228
Enrollment
10
Registered
2015-08-20
Start date
2014-12-31
Completion date
2015-08-31
Last updated
2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Metabolic Disease

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.

Interventions

OTHERMeal (Eating) Frequency

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

OTHERProtein Composition

Consuming meals with higher or lower protein.

Sponsors

Singapore Institute of Food and Biotechnology Innovation
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Venous Plasma InsulinPostprandially 8.5 hours in response to the various dietsBiochemical variable on a continuous scale.
Blood PressurePostprandially 8.5 hours in response to the various dietsSystolic and Diastolic Pressure measured in mmHg
Interstitial GlucosePostprandially 8.5 hours in response to the various dietsMeasured using a continuous glucose monitor.
Venous Plasma GlucosePostprandially 8.5 hours in response to the various dietsBiochemical variable on a continuous scale.
Venous Plasma TriglyceridePostprandially 8.5 hours in response to the various dietsBiochemical variable on a continuous scale.

Secondary

MeasureTime frameDescription
Subjective Appetite RatingsPostprandially 8.5 hours in response to the various dietsMeasured on a 100mm Visual Analog Scale (VAS). 0mm=Not full at all, 100mm= Extremely full.
Urinary F2 IsoprostanesPostprandially 8.5 hours in response to the various dietsBiochemical variable on a continuous scale.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026