An interventional study of high complex carbohydrates diet given in a diet group in Overweight and Obese, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-11.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Treatment
The investigators aims in the current study are to examine whether the cholinergic status should be considered as another risk factor for the metabolic syndrome and it's co-morbidities and to test the effect of a hypocaloric high complex carbohydrates diet on the cholinergic status of overweight and obese adults with and without the metabolic syndrome.
Intervention studies have demonstrated that the autonomic disturbances of the metabolic syndrome may be reversible. A reduction in body weight induced by a hypocaloric diet exerts a marked reduction in sympathetic activity in obese people with or without metabolic syndrome. Incorporation of regular, moderate intensity aerobic exercise training during a dietary weight loss program does not confer additional benefits on resting sympathetic neural activity, compared with weight loss by diet alone. A new method has been developed to examine the sympathetic-parasympathetic status of an individual - the cholinergic status. Cholinergic Status represents the total soluble circulation capacity for acetylcholine hydrolysis. Higher cholinergic status means the individual is more sympathetic .
A cross sectional study that took place in Tel Aviv Sorasky medical center and included 632 participants found that the cholinergic status is related to metabolic syndrome parameters in a dose response manner and that it correlates significantly with glucose,HbA1c, lipid profile and hs-CRP.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's planned enrollment of 50 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participants are overweight and obese people with and without metabolic syndrome that will participate in diet groups.
Behavioral: high complex carbohydrates diet given in a diet group
diet groups that meet every week for eight weeks or more.
total soluble circulation capacity for acetylcholine hydrolysis
Time frame: 8 weeks or more
Inflammatory markers
hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α
Time frame: 8 weeks or more
ROTEM - rotation thromboelastometry
ROTEM documents the interaction of platelets with the coagulation factors from initial platelet-fibrin interaction, through platelet aggregation, clot strengthening and fibrin cross-linking to eventual clot lysis. Within 30 min, a ROTEM tracing provides information on clotting factor activity, platelet function and any clinically significant fibrinolysis.
Time frame: 8 weeks or more
Metabolic markers
Fasting Glucose, HbA1c,Insulin, lipid profile
Time frame: 8 weeks or more
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Tel-Aviv Sourasky Medical Center