NCT01332708

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 11, 2011

Status Verified

April 1, 2011

Enrollment Period

4 months

First QC Date

April 7, 2011

Last Update Submit

April 8, 2011

Conditions

OverweightObese

Keywords

high complex carbohydrateshypocaloric dietcholinergic statusoverweightobese

Outcome Measures

Primary Outcomes (1)

  • total soluble circulation capacity for acetylcholine hydrolysis

    8 weeks or more

Secondary Outcomes (3)

  • Inflammatory markers

    8 weeks or more

  • ROTEM - rotation thromboelastometry

    8 weeks or more

  • Metabolic markers

    8 weeks or more

Study Arms (1)

Obese and overweight subjects

EXPERIMENTAL

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

Interventions

high complex carbohydrates diet given in a diet groupBEHAVIORAL

diet groups that meet every week for eight weeks or more.

Obese and overweight subjects

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 25kg/m2
  • Stable weight (±1kg)in the previous six months
  • Non smokers

You may not qualify if:

  • Type II diabetes
  • Hypertension pharmacologically treated
  • Cardiovascular disease
  • Renal disease
  • Cirrhosis and end-stage liver failure
  • Thyroid disease
  • Cerebrovascular disease
  • Cancer
  • Autoimmune disease
  • Chronic inflammatory disease
  • Surgery or heart catheterization in the previous six months
  • Use of drugs known to affect measured parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 11, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

April 11, 2011

Record last verified: 2011-04