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NCT Number: NCT07130318

Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Aerobic Exercise

Familial Mediterranean fever (FMF) affect liver and causes some dysfunctions including non-alcoholic fatty liver.. still exercise and diet limitation is the treatment for this case

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Key information

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

Location status: Recruiting

Location contact

Ali Ismail, lecturer

CONTACT

[email protected]

+201005154209

Ali MA Ismail, Lecturer

PRINCIPAL_INVESTIGATOR

About this study

Familial Mediterranean fever (FMF women with fatty liver) will be collected to be cateogarized to group I or group II. Every group OF FMF will contain 20 FMF women. Both groups will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months. Group I will also perform elliptical aerobic exercise (this exercise will be applied for 40 minutes three times weekly and this exercise will be maintained for 6 months)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • familial Mediterrean fever women
  • obese women
  • women who have fatty live (non alcoholic type)

Exclusion criteria

  • cardiac patients
  • respiratory disease
  • renal disease
  • cancer

Treatment and study plan

exercise plus diet restriction

Behavioral

Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months. also, this group, Group I, will also perform elliptical aerobic exercise (this exercise will be applied for 40 minutes three times weekly and this exercise will be maintained for 6 months)

diet restriction

Behavioral

Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months.

Primary outcomes

  1. aspartate transaminase

    Time frame: it will be measured after 6 months

    it is a hepatic enzyme

Secondary outcomes

  1. alanine transaminase

    Time frame: it will be measured after 6 months

    it is a hepatic enzyme

  2. body mass index

    Time frame: it will be measured after 6 months

    it will be measured after patient emptying his bowel and bladder

  3. waist circumference

    Time frame: it will be measured after 6 months

    it will be measured at umbilical level

  4. high density lipoprotein

    Time frame: it will be measured after 6 months

    it will be measured in plasma

  5. triglycerides

    Time frame: it will be measured after 6 months

    it will be measured in plasma

  6. cholesterol

    Time frame: it will be measured after 6 months

    it will be measured in plasma

  7. low density lipoprotein

    Time frame: it will be measured after 6 months

    it will be measured in plasma

  8. c reactive protein

    Time frame: it will be measured after 6 months

    it will be measured in plasma

  9. erythrocyte sedimentation rate

    Time frame: it will be measured after 6 months

    it will be measured in plasma

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Ismail, lecturer

CONTACT

[email protected]

Ali MA Ismail, lecturer

CONTACT

[email protected]

01005154209

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Elliptical Aerobic Exercise

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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