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Mediterranean Diet Versus Exercise to Lower Cardiometabolic Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155112
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
The National Association for Public Health, Norway
Information provided by (Responsible Party):
Maya Codruta Ticala Bass, Oslo University Hospital

Brief Summary:
Rates of overweight and obesity continue to climb globally, also in Norway. Cardiometabolic consequences of body fat accumulation includes diabetes type 2 and cardiovascular disease. Progress is needed towards ameliorating these risk, particulary in vulnerable patients. Modifying energy balance has proven to be difficult. Adiposity is activly regulated and defended in obese as in normal weight persons.Thus, most weight loss attempts are followed by weight regain. Lifestyle improvements give substantial benefits and may be preferable to unsuccessful and repeated attempts to loose weight permanently

Condition or disease Intervention/treatment Phase
Overweight or Obesity Visceral Steatosis Other: Exercise Other: Mediterranean diet Not Applicable

Detailed Description:

Patient with obesity and ectopic fat (examples: visceral, pancreatic, intramuscular, hepatic) and risk og type 2 diabetes and cardiovascular disease (CVD) benefit from interventions that lower body weight. Diet and physical activity are optimal. Adherence to a Mediterranean diet with and without weight loss reduce the incidence of CVD and was superiour to a low fat diet in lowering ectopic fat. Exercise lowers risk of type 2 diabetes and contributes to weight loss. Addition of exercise after 6 month of dieting decreased visceral fat without weight loss, suggesting that reduction in ectopic fat in addition to increased lean body mass explain the benefits of exercise.

Poor motivation, physical limitations, socioeconomic factors and lack of enjoyment of exercise are common. and represent a major barrier to lifestyle change. Initiating one lifestyle change at a time (diet or exercise) may improve adherence.

Studies examining the effects og lifestyle change on disease outcomes are difficult to conduct due to long follow up and large samples required. In the abscence of of hard outcomes, surrogate endpoints are of considerable importance in guiding lifestyle advice. Recently software has been developed to quantify ectopic fat deposits using MRI technology.

To our knowledge, studies looking at the differential effects of dietary change versus physical activity on ectopic fat deposits using advanced technology have not been done.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mediterranean Diet Versus Exercise to Lower Cardiometabolic Risk in Vulnerable Populations
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exercise
Participants randomized to exercise will receive exercise sessions of 50 minutes twice weekly for 4 weeks led by experienced exercise instructors, thereafter once weekly with an instructor and twice weekly without an instructor (up to 6 month)
Other: Exercise
energy deficit by increased physical activity

Active Comparator: Mediterranean diet
Participants randomized to dietary group will be counseled by experienced dietitians to follow the Mediterranean diet with Nordic modifications with follow up sessions at biweekly intevals to reinforce changes (up to 6 month)
Other: Mediterranean diet
energy deficit by dieting




Primary Outcome Measures :
  1. Visceral adipose tissue volume [ Time Frame: 6 month ]
    Compare the effect of weight loss by diet and by physical exercise on visceral adipose tissue volume examined by MRI


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 6 month ]
    Compare the impact of weight loss by diet and by physical exercise on blood pressure

  2. HbA1C [ Time Frame: 6 month ]
    Compare the effect of weight loss by diet and by physical activity on HbA1c

  3. Total cholesterol, LDL cholesterol, HDL cholesterol [ Time Frame: 6 month ]
    Compare the effect of weight loss by diet and by physical exercise on total cholesterol, LDL cholesterol, HDL cholesterol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 25 - 40 kg/m2
  • Visceral fat volume above the cut-off of the sex-adjusted population mean for overweight or obese subjects,
  • Sedentary lifestyle (less than 60 minutes physical activity/week)
  • Currently not following a weight loss diet

Exclusion Criteria:

  • Diabetes type 1
  • Known cardiovascular disease
  • Eating disorder or dietary restrictions
  • Alcohol or drug abuse
  • Impediments to exercise at recommended level due to musculoskeletal or other conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155112


Contacts
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Contact: Maya CT Bass, MD 004723033588 maybas@ous-hf.no
Contact: Serena Tonstad, MD,phD 004722894941 serton@ous-hf.no

Locations
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Norway
Oslo University Hospital, Aker
Oslo, Norway, 0424
Contact: Serena Tonstad, MD,phD    004722894941    serton@ous-hf.no   
Principal Investigator: Maya Bass, MD         
Sponsors and Collaborators
Oslo University Hospital
The National Association for Public Health, Norway
Investigators
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Study Chair: Serena Tonstad, MD,phD Oslo University Hospital
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Responsible Party: Maya Codruta Ticala Bass, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04155112    
Other Study ID Numbers: 2019/696
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Overweight
Body Weight
Liver Diseases
Digestive System Diseases