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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Psychosis; Bipolar Disorder; Schizophrenia

• Registration Number: NCT06197048
• Lead Sponsor: Vestre Viken Hospital Trust

Brief 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.

Detailed 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 Timeline

• Study Start: 2023-09-25
• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-05-15
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• > 18 years
• Diagnosed with either schizophrenia/psychosis or bipolar affective disorder
• Patients treatet in Vestre Viken healthcare company, at either Asker district psychiatric center or Blakstad hospital

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Non-HDL cholesterol	6 weeks	HDL-cholesterol - total cholesterol, biochemical test

Secondary Outcome Measures

Name	Time	Method
waist circumference	6 weeks	anthropometric measurement
Bloodpressure	6 weeks
Vitamin D	6 weeks	biochemical test
Folate	6 weeks	biochemical test
Weight	6 weeks	anthropometric measurement
24-hour dietary recall	6 weeks	interview
Food frequency questionnaire	6 weeks	questionnaire
Triglycerids	6 weeks	biochemical test
fasting glucose	6 weeks	biochemical test
HDL-cholesterol	6 weeks	biochemical test
HbA1c	6 weeks	biochemical test
total cholesterol	6 weeks	biochemical test
ALT AST/ALT AST/ALT	6 weeks	biochemical test
LDL-cholesterol	6 weeks	biochemical test

Trial Locations

Locations (2)

Vestre Viken Health Trust; 🇳🇴 Drammen, Viken, Norway

Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospital Trust; 🇳🇴 Drammen, Norway