Calorie Restriction Retards the Aging Process
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|ClinicalTrials.gov Identifier: NCT01508091|
Recruitment Status : Unknown
Verified October 2012 by MARIA PIA DE LA MAZA, University of Chile.
Recruitment status was: Recruiting
First Posted : January 11, 2012
Last Update Posted : October 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: energy restricted mediterranean-type diet Behavioral: 25 % calorie restriction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Calorie Restriction Retards the Aging Process by Inducing Sirtuins and Uncoupling Protein 3, Thereby Reducing the Production of Reactive Oxygen Species.|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2013|
Experimental: Calorie restricted
25 % calorie restriction respect measured total energy expenditure, using a Mediterranean diet
Behavioral: energy restricted mediterranean-type diet
Prescription of diet 25 % lower than actual total energy expenditure in overweight or moderately obese premenopausal women
Behavioral: 25 % calorie restriction
25 % calorie restriction respect total energy expenditure
- UCP3 mRNA expression in vastus lateralis after energy restriction [ Time Frame: 3 months ]The main outcome measure will be UCP3 mRNA expression in vastus lateralis, which will be measured before and after the 3 month intervention period. This enzyme is the last link in the chain of events that occur after calorie restriction. Millet et al reported a value for UCP3 mRNA of 15 ± 1.5 amol/ìg total RNA in 18 subjects. Expecting a 60% increase over baseline in the expression of the enzyme, 17 subjects per group are required to obtain results with an á of 0.05 and a power of 0.8. Considering attrition rates, we must study 24 subjects per group.
- Brown adipose tissue (BAT) activity, indicating UCP1 expression after calorie restriction [ Time Frame: 3 months ]Active BAT and its activation with cold exposure in humans, was demonstrated measuring 18 fluorodeoxyglucose uptake using PET‐CT and colocalized the areas of 18F‐FDG uptake to the expression of UCP1 thus for practical purposes it is a non invasive and reliable method to detect the presence of the tissue and the activity of UPC1, whic is downregulated by energy restriction.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508091
|Contact: Maria Pia de la Maza, MDfirstname.lastname@example.org|
|Contact: Daniel Carlos Bunout, MDemail@example.com|