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Completed

NCT Number: NCT02259244

Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients

The purpose of this study is to evaluate the combined effect of physical activity and adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative stress in obese patients enrolled in the weight management reduction program.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI ≥ 30 kg/m2

Exclusion criteria

  • newly diagnosed diabetes, hypertension or cardiovascular disease
  • change in antihypertensive therapy and antidiabetic therapy in the period of 3 months prior to the commencement of the study
  • insulin therapy
  • alcohol consumption >500 g of alcohol/week in the last year
  • pregnancy or breast feeding
  • use of drugs affecting weight control (eg. weight loss medication or systemic glucocorticoids)

Treatment and study plan

Weight reduction program

Behavioral

Primary outcomes

  1. Oxidative stress

    Time frame: The outcome measure is studied at baseline, 1 and 12 months

Secondary outcomes

  1. Body weight (kg)

    Time frame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months

  2. Waist circumference (cm)

    Time frame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months

  3. Fasting glycemia

    Time frame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months

  4. Lipid profile (HLD, LDL, TC,)

    Time frame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months

  5. Urate

    Time frame: The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months

  6. Blood pressure (mmHg)

    Time frame: The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months

  7. Physical activity level

    Time frame: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months

    IPAQ-SF for record on physical activity during 7 last 7 days.

  8. Quality of life

    Time frame: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months

    SF-36 questionnaire

  9. Dietary intakes

    Time frame: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months

    Food Frequency Questionnaire 7-day food diary

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Collaborators

  • University Hospital Dubrava

Registry information

Official study title

Effect of the Mediterranean Diet and Hypolipemic Reduction Diet in Combination With Exercise in Obese Croatian Population- 1-year Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2014
Registry last updated
Oct 8, 2014

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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