- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04050475
The Evaluation of the Efficacy of a Fasting Mimicking Diet Added to Functional Therapy for Depression
A Randomized-controlled Pilot Study to Evaluate the Efficacy of a Fasting Mimicking Diet Added to Functional Therapy for Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Depression is considered as a systemic illness affecting the whole body and increasing the risk of several diseases. Several studies showed an important link between depression and inflammation. Indeed, depression is associated with the activation of peripheral and central immune-inflammatory pathways indicated by increased levels of proinflammatory cytokines, such as Interleukin-1 β (IL-1β), Interleukin-6 (IL-6), Tumor necrosis factor-α (TNFα) and Interferon-γ (IFNγ). Furthermore, depressed patients present high levels of C-reactive Protein (CRP).
Furthermore, several studies underlined the existence of a link between depression and alterations of the microbiome, as the gut microbiota is implicated as an important health determinant relevant to mental health Several psychotherapy programs have demonstrated to be effective in treating depression, such as Cognitive-Behavioral Therapy (CBT), psychodynamic approaches and mind-body approaches, such as yoga and meditation.
There is some empirical evidence suggesting that the Functional Therapy (FT) approach, that represents an integrated body-mind therapy, highlights the possibility of inducing real changes of the cognitive, emotional and psychological systems through direct body intervention. The purpose of FT for depression is to increase mood and self-esteem through several bodily, cognitive, and emotional techniques by helping depressed patients to improve the Basic Experiences of the Self (BES) altered in this disorder. Furthermore, the integrated treatment provides an overall framework to facilitate lifestyle changes reinforcing assertiveness and self-efficacy.
A considerable body of literature highlighted the role of a healthy diet for reducing the risk of depression. On the other side, a diet based on Western dietary pattern is associated with depressed mood and anxiety. The typology of diet also modulates several key biological processes that underscore mood disorders, such as brain plasticity, stress response system, inflammation, and oxidative processes. Furthermore, practicing a Western dietary pattern implicates a negative effect on our immune system, associating with higher inflammation, and food-related inflammation is associated to increased risk of depression. Indeed, high stress levels and poor diet may lead to a disruption of the Hypothalamic-Pituitary-Adrenal (HPA) axis, with consequent increasing of cortisol's level, low-grade systemic inflammation and oxidative stress.
In this regard, a specific typology of diet oriented on fasting has proved to be effective on several parameters related to health. Cheng and colleagues (2014) found that periodic prolonged fasting promote stress resistance, self-renewal, and lineage-balanced regeneration; moreover, their results showed that cycles of fasting reduced the immunosuppression and mortality caused by chemotherapy in mice. A gradual calorie restriction, mimicking fasting effects but providing all macro- and micro-nutrients on mice rejuvenated the immune system, extended longevity, bring to lowered visceral fat, reduced cancer incidence and retarded bone mineral density loss. Furthermore, the authors found that in old mice FMD cycles promoted hippocampal neurogenesis and improved cognitive performance and motor coordination. Moreover, a Fasting Mimicking Diet protocol was associated with a significant reduction of TNFα, IL-1β and IL-6, and this decrease could positively influence the mood.
Given these premises, the aim of this clinical trial were:
- Verify the efficacy of a structured FT program, delivered in individual setting, for patients with depression (PSY group);
- Verify whether the association of a FMD protocol with the structured FT program significantly improves clinical outcomes (PSY-FMD group).
Patients were enrolled from January 2018 to March 2019 and were recruited via advertisement posted in our outpatient clinic. For the recruitment a structured telephone screening helped the researchers to investigate on some exclusion criteria. Then a consultation with a clinical psychologist and with a psychiatrist were programmed together with the administration of the psychological tests. Psychological assessment included an ad-hoc sociodemographic questionnaire; a shortened version of Wechsler Adult Intelligence Scale - Revised (WAIS-R); Millon Clinical Multiaxial Inventory-III (MCMI-III); Beck Depression Inventory-II (BDI-II); Basic Self-Esteem Scale (Basic SE); World Health Organization Quality of Life-BREF (WHOQOL-BREF). Anthropometric parameters included weight, height and waist circumference.
Six different therapists with a 4-year postgraduate training on FT applied the intervention. All therapists took part to a refresher training oriented to the application of the structured FT protocol for depression. Each therapist treated four patients. A nutritionist prescribed the FMD protocol after a consultation. After the assessment, eligible subjects were randomized in the PSY-FMD group or in the PSY group and were assigned to the next therapist on a time capacity list. A block randomization was used, so that number of patients per condition were balanced within therapists. The resulting samples comprised 20 depressed subjects. Four patients dropped out. There were no pre-treatment group differences on age, sex, marital status and years of education. Furthermore, both groups were homogeneous on Intelligence Quotient, the presence of psychiatric comorbidities or personality disorders, as well as for the level of depression, self-esteem, quality of life and BMI.
Ten subjects were randomized in the PSY-FMD group and they carried out the FT 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). None of the patients were undergoing psychopharmacological treatment. The treatment program was specifically manualized for treating depression with the aim to increase mood, self-esteem and quality of life. Specifically, the treatment program was oriented towards the reduction and/or elimination of mood unbalance through several bodily, cognitive and emotional techniques, such as deep breathing, specific guided imagery, techniques for improving assertiveness and for improving social abilities. Furthermore, patients recruited in the PSY-FMD group, followed a 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.
Ten subjects were randomized into the control group (PSY) and completed the same FT 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.
At the end of the treatment all patients were re-tested through the same assessment protocol (psychological tests, anthropometric measures and nutritional consultation) to analyse the achievement of the expected outcomes and the same things was realized at the follow-up (three months later the end of the treatment).
Group differences in demographic features and pre-treatment measures were analysed with independent samples t-tests and χ2- tests. In order to evaluate the pre-post treatment alterations, a repeated ANOVA measurement was used at baseline, at the end of treatment and at the follow-up period. All analyses assumed an alpha risk of 5%. All statistical analyses were conducted using Statistical Package for Social Science for Windows 22.0.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Palermo, Italy, 90100
- Unit of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PSY-FMD
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).
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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.
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No Intervention: PSY
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
severity of depressive symptoms measured by the second version of the Beck-Depression-Inventory (BDI-II)
Time Frame: end of the treatment (three months) and three months later (follow-up)
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change of depression symptoms (measured through Beck Depression Inventory -II).
Total score from 0 to 63.
Higher values represent worst depression symptoms
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end of the treatment (three months) and three months later (follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self-esteem measured by the Basic Self-Esteem Scale
Time Frame: end of the treatment (three months) and three months later (follow-up)
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change of self-esteem (measured through Basic Self-Esteem Scale).
Percentiles scores were used (from 0 to 100).
Higher values indicate a better self-esteem
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end of the treatment (three months) and three months later (follow-up)
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quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Time Frame: end of the treatment (three months) and three months later (follow-up)
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change of Quality of Life (measured through World Health Organization Quality of Life BREF).
Subscales: physical health, psychological health, social relationships, and environment.
Score from 0 to 100.
Higher values represent a better quality of life in each area
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end of the treatment (three months) and three months later (follow-up)
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOPalermo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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