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The effects of macronutrients on postprandial vascular function in overweight and slightly obese men

The effects of macronutrients on postprandial vascular function in overweight and slightly obese men - Macronutrients and postprandial vascular function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47116
Enrollment
20
Registered
2018-07-11
Start date
2017-12-13
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Insulin Resistance Syndrome Metabolic Syndrome Syndrome X

Interventions

During each of the three experimental days, the volunteers will participate in a postprandial test. For this, they receive in random order a high-fat (HF-LC-LP) milkshake, high-carbohydrate (LF-HC-L
Vascular function

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Aged between 18-70 years - Men - BMI between 25-35 kg/m2 (overweight and slightly obese) - Fasting plasma glucose

Exclusion criteria

Exclusion criteria: - 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 3 kg in the past three months) - Use medication known 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

Design outcomes

Primary

MeasureTime frame
Measurements will be performed before and two hours after consumption of the milkshakes. The primary endpoint is the difference in postprandial change in FMD between the HF-LC-LP, LF-HC-LP and LF-LC-HP meal.

Secondary

MeasureTime frame
Secondary outcomes are the postprandial effects of a HF-LC-LP, LF-HC-LP and LF-LC-HP meal on other markers reflecting vascular function (PWA, PWV and retinal microvascular caliber), plasma markers for low-grade systemic inflammation and endothelial dysfunction, blood pressure, and serum lipid and plasma glucose metabolism.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)