Influence of Nutrition in Depression Treatment (INDEPT)

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).

Conditions

• Major Depressive Disorder - MDD

Interventions

BEHAVIORAL

Promotion of adherence to the MedDiet

Participants will be followed in six individual nutrition consultations with a duration of 30 to 60 minutes. The consultations will be focused on promoting the adherence to the MedDiet. The nutritional intervention will be personalized to each individual ad libitum, without calories or macronutrients restriction and without the goal to promote weight change. The intervention will begin with an initial assessment of the dietary patterns of the participants in which the nutritionist will identify potential behavioural changes to promote adjustments in dietary habits and therefore adherence to the MedDiet. The intervention will promote positive recommendations (behaviours recommended to follow) and negative recommendations (behaviours recommended to reduce or eliminate) (26), using the strategy and MedDiet definition proposed by Estruch et al. in the "Primary Prevention of Cardiovascular Disease with a Mediterranean Diet" study (3). The participants will also maintain MDD TAU.

Sponsors & Collaborators

• University of Lisbon

  collaborator OTHER

• Instituto Politécnico de Leiria

  collaborator OTHER

• Fundação para a Ciência e a Tecnologia

  collaborator OTHER

• Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA

  lead OTHER

Principal Investigators

• Maria João Heitor, PhD · Instituto de Saúde Ambiental, Faculdade de Medicina da Universidade de Lisboa, Portugal

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-05

Primary Completion

2025-01-31

Completion

2025-12-31

Countries

• Portugal

Study Locations