onger-term effects of a novel nutritional combination on muscle insulin sensitivity and mitochondrial function, and vascular function in abdominally obese subjects

Completed

Conditions: Insulin Resistance Syndrome
Metabolic Syndrome
Syndrome X
10018424

Registration Number: NL-OMON48206

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 88

Inclusion Criteria

- Aged between 50-70 years
- Men and postmenopausal (two or more years after last menstruation) women
- Waist circumference for men > 102 cm and for women > 88 cm (abdominally obese)
- Impaired fasting glucose concentrations (between 5.6 - 7.0 mmol/L in
accordance with the American Diabetes Association guidelines for prediabetes)
at two screening visits
- Fasting serum total cholesterol < 8.0 mmol/L
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- 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
- Willingness to give up the use of antibacterial mouth wash or antibacterial
toothpaste, chewing-gum and tongue-scraping during the study

Exclusion Criteria

- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Use of dietary supplements known to interfere with the main study outcomes as
judged by the principal investigators
- Use of anticoagulant drugs or drugs to treat blood pressure, lipid/glucose
metabolism
- Use of an investigational product within another biomedical intervention
trial within the previous 1-month
- Intolerance or allergy to the ingredients of the intervention products
- Severe medical conditions that might interfere with the study, such as
epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive
pulmonary disease (COPD), 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the difference in muscle insulin sensitivity between<br /><br>the intervention and the control period. All measurements will be performed<br /><br>fasted.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A muscle biopsy will be taken to assess mitochondrial function. Vascular<br /><br>function and characteristics of muscle vasculature will be assessed during<br /><br>another test day.</p><br>