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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00364338
Other study ID # 30-150906-HMO-CTIL
Secondary ID
Status Withdrawn
Phase N/A
First received August 14, 2006
Last updated September 20, 2015
Start date January 2007
Est. completion date December 2008

Study information

Verified date August 2006
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Interventional

Clinical Trial Summary

Subjects that participate in the practical workshop will improve their metabolic indexes, decrease their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions


Description:

Participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop. The workshop will consist of 9 lessons with the following lessons: introduction, fats, phytoestrogens, carbohydrates and fibers, calcium and low calorie diet, party's recipes, shopping and farewell dinner. All the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours "hands on" session under supervision of a medical chef. The study population will include healthy women attending the menopause clinic. 72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only. During 2008 the control group will commence the workshop and will add to the study group.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 60 Years
Eligibility Inclusion Criteria:

- Age of 45-60

- Perimenopause

- Healthy

- BMI over 17

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
gourment cooking workshop


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary We expect to see change in the following outcomes:
Primary the patient's metabolic state,
Primary the patient's weight
Primary body composite
Primary patient's quality of life.
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