The Evaluation of the Efficacy of a Fasting Mimicking Diet Added to Functional Therapy for Depression

NCT04050475 | Completed

• 1 other identifier: AOPalermo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Depression has to be considered as a systematic illness involving the whole body, it is often associated with low-grade inflammation and alterations of the microbiome. In this regard, an unhealthy diet increases the risk of the onset of this disorder, therefore an integrated treatment including a healthy diet could be more effective. The aim of our study were to verify the efficacy of a structured FT program, delivered in individual setting, for patients with depression (PSY group), and to verify whether the association of a FMD protocol with the structured FT program significantly improves clinical outcomes (PSY-FMD group). After a psychiatric, psychological and anthropometric assessment, depressed patients were randomly assigned to psychotherapy and diet (PSY-FMD) or just psychotherapy (PSY). PSY-FMD participants received 20 individual sessions of Functional Psychotherapy. Each session attended twice a week for the first 8 weeks and once a week for the remaining 4. Furthermore, they received a nutritional consultation and prescription of a Fasting Mimicking Diet. PSY group received just the psychotherapy protocol and the nutritional consultation. All patients were retested at the end of the treatment and at follow-up 3 months after the last session. In both groups was highlighted a strong effectiveness of treatments on depression, self-esteem and quality of life. In the PSY-FMD group compared to PSY a significant effect was found on the improvement of self-esteem and quality of life. Furthermore, a significant reduction of BMI was found in the PSY-FMD group. The current study supports the effectiveness of the combination of psychotherapy with a fasting mimicking diet in adult depressed patients.

Conditions

Depression

Keywords

Depression; Fasting Mimicking Diet; Functional Therapy; Lifestyle Medicine; Health Psychology; Psychosomatic

Outcome Measures

Primary Outcomes (1)

• severity of depressive symptoms measured by the second version of the Beck-Depression-Inventory (BDI-II)

  change of depression symptoms (measured through Beck Depression Inventory -II). Total score from 0 to 63. Higher values represent worst depression symptoms

  end of the treatment (three months) and three months later (follow-up)

Secondary Outcomes (2)

• self-esteem measured by the Basic Self-Esteem Scale

  end of the treatment (three months) and three months later (follow-up)

• quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)

  end of the treatment (three months) and three months later (follow-up)

Study Arms (2)

PSY-FMD

EXPERIMENTAL

Subjects randomized in the PSY-FMD group carried out the Functional Therapy protocol over 20 individual sessions, which were scheduled twice a week for the first two months and once a week for the last month (three months total). The treatment program was specifically manualized for treating depression with the aim to increase mood, self-esteem and quality of life. Furthermore, patients followed a Fasting Mimicking Diet (FMD) protocol consisting of 3 cycles of 5 days a month each: the first day of the diet provided 1090 kcal (10% protein, 56% fat, 34% carbohydrate), the days 2-5 were identical in the formulation and provided 725 kcal (9-10% protein, 44-56% fat, 34-47% carbohydrate). Between cycles of FMD the subjects stuck to a free diet. At the end of the treatment all patients were re-tested through the same assessment protocol and the same things was realized at the follow-up (three months later the end of the treatment).

Dietary Supplement: Fasting Mimicking Diet

PSY

NO INTERVENTION

Subjects randomized into the control group (PSY) completed the same Functional Therapy program without practicing any diet. Specifically, at the end of the nutritional consultation the nutritionist suggested them to keep a food diary without changing their habitual diet style.

Interventions

Fasting Mimicking Diet DIETARY_SUPPLEMENT

The Fasting Mimicking Diet is a low-calorie, five-day eating program meant to promote weight loss and provide the same benefits as more traditional fasting methods.

PSY-FMD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• a score at the Beck Depression Inventory - II (BDI-II) over than 13 at the time of initial assessment;
• age from 18 to 60 years old;
• seeking treatment for mood problems;
• not involved in a concurrent treatment;
• without any psychopharmacological treatment for depression in the previous 12 months;
• without any practice of yoga or meditation;

You may not qualify if:

• a current or lifetime diagnosis of psychotic disorders, borderline, schizotypal, or antisocial personality disorder, active suicidal ideation with a plan, eating disorders, bipolar disorder, primary anxiety disorder
• a past or present of drug abuse or drug addiction (excluding nicotine)
• chronic inflammation diseases
• eating disorders
• IQ less than 65
• BMI less than 18.5 or more than 30
• severe hepatic failure
• serious infections (such as HIV, hepatitis B and C)
• cancer in the previous 6 months
• regular use of anti-inflammatory drugs for more than 15 days/month

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead
• University of Palermo: collaborator
• Centro Studi Psicoterapia Neo-Funzionale: collaborator

Study Sites (1)

Unit of Psychiatry

Palermo, 90100, Italy

Location

Related Publications (1)

• Maniaci G, La Cascia C, Giammanco A, Ferraro L, Chianetta R, Di Peri R, Sardella Z, Citarrella R, Mannella Y, Larcan S, Montana S, Mirisola MG, Longo V, Rizzo M, La Barbera D. Efficacy of a fasting-mimicking diet in functional therapy for depression: A randomised controlled pilot trial. J Clin Psychol. 2020 Oct;76(10):1807-1817. doi: 10.1002/jclp.22971. Epub 2020 May 11.

  PMID: 32394438 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were advised that they would have received a psychological treatment and a nutritional consultation in order to evaluate the possibility of the prescription of a diet, investigating on their diet habits The investigator wasn't informed about the randomization procedures of the two groups. A clinical psychologist administered the psychological tests separately in the same treatment centre were the patients received the protocol and he wasn't aware about the randomization arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After a psychiatric, psychological and anthropometric assessment, depressed patients were randomly assigned to psychotherapy and diet (PSY-FMD) or only psychotherapy (PSY) groups. PSY-FMD participants received 20 individual sessions of Functional Psychotherapy. Each session attended twice a week for the first 8 weeks and once a week for the remaining 4. Furthermore, they received a nutritional consultation and prescription of a Fasting Mimicking Diet. PSY group received just the psychotherapy protocol and the nutritionist prescribed to keep a food diary without changing their habitual diet style. All patients were retested at the end of the treatment (3 months later) and at follow-up 3 months after the last session.

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 8, 2019
• Study Start: September 12, 2018
• Primary Completion: May 23, 2019
• Study Completion: June 27, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

IT (1)