A Randomized-controlled Pilot Study to Evaluate the Efficacy of a Fasting Mimicking Diet Added to Functional Therapy for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- severity of depressive symptoms measured by the second version of the Beck-Depression-Inventory (BDI-II)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Fasting Mimicking Diet (Dietary Supplement)
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.
结局指标
主要结局
severity of depressive symptoms measured by the second version of the Beck-Depression-Inventory (BDI-II)
时间窗: end of the treatment (three months) and three months later (follow-up)
change of depression symptoms (measured through Beck Depression Inventory -II). Total score from 0 to 63. Higher values represent worst depression symptoms
次要结局
- 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))
研究者
Giuseppe Maniaci
Principal Investigator
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
