Nutritional Counselling Promoting Adherence to the Mediterranean Diet as Adjuvant in the Treatment of Major Depressive Disorder: A Randomized Open Controlled Trial Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The hypothesis to be tested by this study is that an intervention promoting adherence to the MedDiet can decrease symptoms of depression in patients with elevated inflammation biomarkers, namely C-reactive protein (CRP) and Interleukin 6 (IL-6) diagnosed with Major Depression Disorder (MDD), under treatment with antidepressant medication for a period of time less than or equal to 6 months. The main aim of this study is to understand if promoting the adherence to the MedDiet, as an adjuvant strategy in the treatment of MDD, is effective in decreasing symptoms of depression in MDD patients, with elevated levels of inflammation biomarkers. Other specific objectives of the study are 1. To assess the association between adherence to MedDiet and changes in inflammatory biomarkers; 2. To assess the association between changes in inflammatory biomarkers with symptoms of MDD; 3. To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD; 4. To characterize the association between adherence to MedDiet and changes in health-related quality of life 5. To evaluate the economic cost-effectiveness of dietary counselling, as an adjuvant treatment in MDD. The study will have a duration of 12 weeks, with a randomized parallel-group open controlled trial design, with two parallel groups with an allocation ratio of 1:1 - (a) intervention arm with six nutritional consultations with a registered nutritionist, promoting adherence to MedDiet, in addition to MDD Treatment-As-Usual (TAU) and (b) control group arm benefitting only from MDD TAU. A follow up assessment will be performed at 6- and 12-months. Having into consideration an attrition of 40 percentage at the end of the intervention, the minimum sample size estimated is 190 (95 per arm). The main outcome of the trial, changes in symptoms of depression, will be evaluated using the Beck Depression Inventory Second Edition (BDI-II).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Aged between 18-70 years old

• Able to understand and provide informed consent

• Able to read and write

• Have a diagnosis of MDD (according to ICD-10 F32.0; F32.1; F32.2; F32.9; F33.0; F33.1; F33.2; F33.9 criteria)

• Score on the Beck Depression Inventory-II scale (BDI-II) \> 13;

• Elevated biomarkers of inflammation (CRP \> 3mg/l or IL-6 ≥ 2pg/ml )

• Able to follow a MedDiet without impeditive physical or religious limitations, allergies or intolerances

• Being under pharmacological treatment for depressive disorder

Locations
Other Locations
Portugal
Centro Hospitalar de Leiria - Hospital Santo André
RECRUITING
Leiria
Hospital de Beatriz Ângelo - Hospital de Loures, EPE
RECRUITING
Loures
Contact Information
Primary
Nuno Sousa-Santos, BSc
nunoneto@edu.lisboa.pt
00351913295919
Backup
Cátia Clara, BSc
study.indept@gmail.com
00351965053469
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 190
Treatments
Experimental: Interventional Group
Interventional group with six nutritional counselling consultations promoting the adherence to the MedDiet and TAU for MDD
No_intervention: Control Group
Individuals with TAU for MDD
Related Therapeutic Areas
Sponsors
Collaborators: Fundação para a Ciência e a Tecnologia, University of Lisbon, Instituto Politécnico de Leiria
Leads: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA

This content was sourced from clinicaltrials.gov

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