Effect of Nutritional Counseling on Anthropometry & Biomarkers in Patients

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to compare the effect of nutritional counseling versus no treatment in patients with schizophenia or bipolar affective disorder. The main question it aims to answer are: • Can nutritional counseling have a preventive effect on the development of cardiovascular disease in patients with schizophenia or bipolar affective disorder? Participants will meet a nutritionist at baseline to asess nutritional status, biochemical and anthropometric measurements. Then, half of the study population will receive nutritional counseling. After six weeks, the same baseline measurements will be repeated to examine any potential differences between the two groups. After the intervention, the control group will be offered the same counseling as the intervention group received during the study.

Clinical Trial Description

People with severe mental illness have a shorter life expectancy compared to the general population. Individuals with schizophrenia or bipolar affective disorder have an estimated reduce life expectancy by an average of 10-20 years. Increased mortality is caused by many factors, but cardiovascular diseases contributes the most. Increased prevalence of cardiovascular disease is mainly due to a poor lifestyle, which includes smoking, physical inactivity and an unhealthy diet. It is important to find treatment that can provide better quality of life and longer life expectancy in these patient groups. Few clinical studies have been conducted on the effect of nutritional counseling on biochemical and anthropometric measurements related to cardiovascular diseases. Therefore, we want to investigate this through a randomized controlled trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06197048
Study type	Interventional
Source	Vestre Viken Hospital Trust
Contact	Dawn E Peleikis, phD
Phone	+4799405812
Email	dawn.peleikis@vestreviken.no
Status	Recruiting
Phase	N/A
Start date	September 25, 2023
Completion date	December 1, 2028

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms