NCT03139890

Brief Summary

Vascular function decreases following the intake of a mixed meal in some, but not all studies. Differences in the relative amounts of dietary fat, carbohydrates and protein present in the mixed-meal challenges may have contributed to these apparently inconsistent results. Well-designed trials - comparing under rigorously standardized conditions - on the effects of macronutrients on postprandial vascular function are missing. The primary objective of the current study is thus to evaluate in overweight and slightly obese men the effects of the three macronutrients (fat, carbohydrates, and protein) on postprandial vascular function, as assessed by brachial artery flow-mediated vasodilation (FMD). Secondary objectives are to examine postprandial effects on other markers reflecting vascular function, plasma markers for low-grade systemic inflammation and endothelial dysfunction, blood pressure, and serum lipid and plasma glucose metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

May 2, 2017

Last Update Submit

September 12, 2018

Conditions

Dietary FatsCarbohydratesProteinsMacronutrientsVascular FunctionPostprandial Metabolism

Outcome Measures

Primary Outcomes (1)

  • Vascular endothelial function

    Flow-mediated vasodilation (FMD) of the brachial artery

    Change from baseline at 2 hours after milkshake consumption

Secondary Outcomes (4)

  • Vascular function markers

    Change from baseline at 2 hours after milkshake consumption

  • Cardiometabolic risk markers

    Change from baseline at 2 hours after milkshake consumption

  • Cardiometabolic risk markers

    During 4 hours following milkshake consumption

  • Postprandial metabolism

    During 4 hours following milkshake consumption

Study Arms (3)

High-fat milkshake

EXPERIMENTAL
Other: High-fat (HF-LC-LP) milkshake

High-carbohydrate milkshake

EXPERIMENTAL
Other: High-carbohydrate (LF-HC-LP) milkshake

High-protein milkshake

EXPERIMENTAL
Other: High-protein (LF-LC-HP) milkshake

Interventions

High-fat (HF-LC-LP) milkshakeOTHER

During this experimental day, men will receive a high-fat milkshake

High-fat milkshake
High-carbohydrate (LF-HC-LP) milkshakeOTHER

During this experimental day, men will receive a high-carbohydrate milkshake

High-carbohydrate milkshake
High-protein (LF-LC-HP) milkshakeOTHER

During this experimental day, men will receive a high-protein milkshake

High-protein milkshake

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18-70 years
  • Men
  • BMI between 25-35 kg/m2 (overweight and slightly obese)
  • Fasting plasma glucose \< 7.0 mmol/L
  • Fasting serum total cholesterol \< 8.0 mmol/L
  • Fasting serum triacylglycerol \< 2.2 mmol/L
  • Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg
  • No current smoker
  • No diabetic patients
  • No familial hypercholesterolemia
  • No abuse of drugs
  • No more than 3 alcoholic consumptions per day
  • Stable body weight (weight gain or loss \< 3 kg in the past three months)
  • No use of dietary supplements known to interfere with the main study outcomes as judged by the principal investigator
  • No use of medication to treat blood pressure, lipid or glucose metabolism
  • +5 more criteria

You may not qualify if:

  • Women
  • Fasting plasma glucose ≥ 7.0 mmol/L
  • Fasting serum total cholesterol ≥ 8.0 mmol/L
  • Fasting serum triacylglycerol ≥ 2.2 mmol/L
  • Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg
  • Current smoker, or smoking cessation \< 12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
  • More than 3 alcoholic consumptions per day
  • Unstable body weight (weight gain or loss \> 3 kg in the past three months)
  • Use of dietary supplements known to interfere with the main study outcomes as judged by the principal investigator
  • Use medication to treat blood pressure, lipid or glucose metabolism
  • Use of an investigational product within another biomedical intervention trial within the previous 1-month
  • Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

Related Publications (3)

  • Gravesteijn E, Mensink RP, Smeets ETHC, Plat J. Dietary Macronutrients Do Not Differently Influence Postprandial Serum and Plasma Brain-Derived Neurotrophic Factor Concentrations: A Randomized, Double-Blind, Controlled Cross-Over Trial. Front Neurosci. 2021 Dec 21;15:774915. doi: 10.3389/fnins.2021.774915. eCollection 2021.

    PMID: 34992516DERIVED

  • Schroor MM, Plat J, Konings MCJM, Smeets ETHC, Mensink RP. Effect of dietary macronutrients on intestinal cholesterol absorption and endogenous cholesterol synthesis: a randomized crossover trial. Nutr Metab Cardiovasc Dis. 2021 May 6;31(5):1579-1585. doi: 10.1016/j.numecd.2021.01.010. Epub 2021 Jan 29.

    PMID: 33744041DERIVED

  • Smeets ETHC, Mensink RP, Joris PJ. Dietary macronutrients do not differently affect postprandial vascular endothelial function in apparently healthy overweight and slightly obese men. Eur J Nutr. 2021 Apr;60(3):1443-1451. doi: 10.1007/s00394-020-02340-y. Epub 2020 Jul 29.

    PMID: 32728881DERIVED

Study Officials

  • Peter J Joris, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

December 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)