AzTrials
AzTrials

Dietary FatsNCT03139890

Macronutrients and Postprandial Vascular Function

A study testing High-fat (HF-LC-LP) milkshake, High-carbohydrate (LF-HC-LP) milkshake and High-protein (LF-LC-HP) milkshake in people with Dietary Fats and Carbohydrates, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Dietary Fats, Carbohydrates, Proteins
What is being tested?
High-fat (HF-LC-LP) milkshake, High-carbohydrate (LF-HC-LP) milkshake and High-protein (LF-LC-HP) milkshake
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNetherlands
Study dates
1 Dec 2017to 1 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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
  • No use of an investigational product within another biomedical intervention trial within the previous 1-month
  • No 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
  • No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
  • Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
  • No difficult venipuncture as evidenced during the screening visit

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
  • Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
  • Not or difficult to venipuncture as evidenced during the screening visit

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center

    Maastricht

Other trials in Netherlands

About this study

Official title: The Effects of Macronutrients on Postprandial Vascular Function in Overweight and Slightly Obese Men

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.

Being tested
High-fat (HF-LC-LP) milkshake, High-carbohydrate (LF-HC-LP) milkshake, High-protein (LF-LC-HP) milkshake

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-fat (HF-LC-LP) milkshakeOther

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

  • High-carbohydrate (LF-HC-LP) milkshakeOther

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

  • High-protein (LF-LC-HP) milkshakeOther

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

Study groups in NCT03139890
Study groupRoleWhat they receive
High-fat milkshakeExperimentalNot described
Receives: Other: High-fat (HF-LC-LP) milkshake
High-carbohydrate milkshakeExperimentalNot described
Receives: Other: High-carbohydrate (LF-HC-LP) milkshake
High-protein milkshakeExperimentalNot described
Receives: Other: High-protein (LF-LC-HP) milkshake

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vascular endothelial function

    Flow-mediated vasodilation (FMD) of the brachial artery

    Measured: Change from baseline at 2 hours after milkshake consumption

Secondary outcomes (4)

  1. Vascular function markers

    Carotid-femoral pulse wave velocity (PWV), pulse wave analysis (PWA), retinal microvascular caliber

    Measured: Change from baseline at 2 hours after milkshake consumption

  2. Cardiometabolic risk markers

    Plasma markers for low-grade systemic inflammation and endothelial dysfunction

    Measured: Change from baseline at 2 hours after milkshake consumption

  3. Cardiometabolic risk markers

    Office blood pressure

    Measured: During 4 hours following milkshake consumption

  4. Postprandial metabolism

    Serum lipid and plasma glucose metabolism

    Measured: During 4 hours following milkshake consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2017
  2. Study start1 Dec 2017
  3. Primary completion1 Sep 2018
  4. Study completion1 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03139890
Sponsor's protocol ID
METC 17-3-012
Status last verified
Sep 2018
First submitted
2 May 2017
Last updated
13 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34992516

  • 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.

    PubMed 33744041

  • 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.

    PubMed 32728881

Questions about this trial

What is this clinical trial studying?

A study testing High-fat (HF-LC-LP) milkshake, High-carbohydrate (LF-HC-LP) milkshake and High-protein (LF-LC-HP) milkshake in people with Dietary Fats and Carbohydrates, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular endothelial function (time frame: Change from baseline at 2 hours after milkshake consumption). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03139890, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.

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