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The effect of dietary phytosphingosine on insulin resistance and cholesterol levels in patients with the metabolic syndrome


- candidate number3220
- NTR NumberNTR1287
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-apr-2008
- Secondary IDsP06-131 
- Public TitleThe effect of dietary phytosphingosine on insulin resistance and cholesterol levels in patients with the metabolic syndrome
- Scientific TitleThe effect of dietary phytosphingosine on insulin resistance and cholesterol levels in patients with the metabolic syndrome
- ACRONYMN/A
- hypothesisPhytosphingosine decreases cholesterol levels and improves insulin sensitivity
- Healt Condition(s) or Problem(s) studiedMetabolic syndrome, Obesity, Diabetes Mellitus, Phytosphingosine
- Inclusion criteria1. Male volunteers
2. Age > 18 years and < 70 years
3. BMI > 27 kg/m2 and < 40 kg/m2
4. Central obesity (waist circumference >94 centimetres)
5. Fasting serum glucose > 5.6 mmol/L
6. Fasting serum insulin >15 mU/L
7. TG ≥ 1.7 mmol/L or HDL-C ≤ 1.03 mmol/L
- Exclusion criteria1. Any significant chronic disease
2. Renal, hepatic or another endocrine disease
3. Use of medication known to influence lipolysis and/or glucose metabolism
4. Difficulties to insert an intravenous catheter
5. Smoking
6. Recent blood donation (within the last 3 months)
7. Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2008
- planned closingdate1-apr-2009
- Target number of participants10
- Interventions- Phytosphingosine, twice a day 0.5 grams for 28 days
- Placebo, twice a day for 28 days
- Primary outcome Glucose metabolism: HOMA-IR, HOMA-β K-value by IVGTT
Plasma concentrations: Total cholesterol (TC), HDL-C-cholesterol (HDL-C), LDL-C-cholesterol (LDL-C), Triglycerides Glucose, insulin
- Secondary outcome Anthropometric:
Weight, height, waist and hip circumference, BIA
Plasma concentrations:
ASAT, ALAT, gamma-GT, LDH, alkaline phosphatase fibrinogen, CRP
- TimepointsBefore and after both 4 week interventions
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M. Snel
- CONTACT for SCIENTIFIC QUERIESDrs. M. Snel
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryBackground:
treatment with phytosphingosine leads to improvement in cholesterol spectrum and insulin resistance in animal models
Objective:
To examine if dietary Phytosphingosines improve insulin sensitivity in male patients with the metabolic syndrome.
To examine if dietary Phytosphingosines improve blood cholesterol levels in male patients with metabolic syndrome.
To examine the safety and possible side effects of dietary Phytosphingosines

Study Design:
Double blind randomized cross-over placebo controlled intervention study
Planned Sample:
10 patients
Drugs and Dosages:
Phytosphingosine, twice a day 0.5 grams for 28 days
Placebo, twice a day for 28 days
Main Parameters:
Anthropometric: Weight, height, waist and hip circumference, BIA
Glucose metabolism: HOMA-IR, HOMA-β K-value by IVGTT
Plasma concentrations: Total cholesterol (TC), HDL-C-cholesterol (HDL-C), LDL-C-cholesterol (LDL-C), Triglycerides Glucose, insulin ASAT, ALAT, gamma-GT, LDH, alkaline phosphatase fibrinogen, CRP
- Main changes (audit trail)
- RECORD21-apr-2008 - 28-apr-2008


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