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van CCT (UK)

van CCT (UK)

Effects of low-fat vs high-fat diet on lipid accumulation in liver and skeletal muscle in overweight men.

- candidate number6795
- NTR NumberNTR2136
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-dec-2009
- Secondary IDs07-3-028 MEC
- Public TitleEffects of low-fat vs high-fat diet on lipid accumulation in liver and skeletal muscle in overweight men.
- Scientific TitleEffects of low-fat vs high-fat diet on lipid accumulation in liver and skeletal muscle in overweight men.
- ACRONYMHigh-fat vs Low-fat diet
- hypothesisA high fat-diet can influence IMCL and IHL in rodents and in humans, the time-course of peripheral lipid accumulation in liver and skeletal muscle while switching from a low-fat to a high-fat diet is unknown.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Insulin resistance, Non-Alcoholic Fatty Liver Disease (NAFLD)
- Inclusion criteria1. Male sex;
2. Age 40-65 years;
3. BMI 25-35 kg/m2;
4. Sedentary;
5. Stable dietary habits;
6. Healthy.
- Exclusion criteria1. Current use of medication that is known to interfere with the results of the study;
2. Consuming more than 20 g of alcohol per day ( 2 units);
3. Serum-γ-glutamyltranspeptidase level > 70 IU/L;
4. A history of cardiovascular disease like congestive heart failure or acute myocardial infarction;
5. Plasma triacylglycerol > 4.5 mmol/L;
6. Familial hypercholesterolemia;
7. A history of liver disease;
8. Unstable body weight (weight gain or loss > 3 kg in the past three months);
9. Abuse of drugs;
10. Participation in another biomedical study within 1 month prior to the screening visit;
11. Impossible or difficult venipuncture during screening;
12. A fasting glucose above 7.0 mmol/L (13);
13. A contraindication to MRI scanning. These contraindications include patients with the following devices:
a. Central nervous system aneurysm clips;
b. Implanted neural stimulator;
c. Implanted cardiac pacemaker or defibrillator;
d. Cochlear implant;
e. Ocular foreign body (e.g. metal shavings);
f. Insulin pump;
g. Metal shrapnel or bullet;
h. Or metal containing corpora aliena in the eye of brains.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2007
- planned closingdate1-mrt-2010
- Target number of participants20
- InterventionsBoth groups, the control group and the experimental group, will start with 3 weeks on a low-fat diet which will deliver 15 Energy% of energy as protein, 65 En% as CHO and 20 En% as fat. After these 3weeks the experimental group will switch to a high-fat diet (15 En% protein, 30 En% CHO and 55% En% fat). wheras the control group stays on the low-fat diet.
- Primary outcomeMain study parameter is the difference in lipid accumulation and insulin sensitivity after a switch from a low-fat diet to a high-fat diet compared to the control group, which stays on a low-fat diet.
- Secondary outcomeAs secondary endpoints differences the time-course of lipid accumulation and the relationship between the tissue parameter lipid ccumulation and the functional outcome parameter insulin resistance are considered.
- TimepointsT=1, T=21 and T=42 (days).
And additional liver lipid accumulation measurement in HF-group on t=28.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
TI Food and Nutrition
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD10-dec-2009 - 5-mrt-2010

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