scholarly journals Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: A Randomized Controlled Pilot Trial

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 902
Author(s):  
Julia A. Sabet ◽  
Moa S. Ekman ◽  
A. Sofia Lundvall ◽  
Ulf Risérus ◽  
Ulrica Johansson ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Control Diet ◽  
Pilot Trial ◽  
Sensory Properties ◽  
Biological Mechanisms ◽  
Double Blind ◽  
Randomized Controlled ◽  
Nordic Diet ◽  
Treatment Of Depression ◽  
Before And After

Healthy diet interventions have been shown to improve depressive symptoms, but there is a need for randomized controlled trials (RCTs) that are double blind and investigate biological mechanisms. The primary objectives of this randomized controlled pilot trial were to test the palatability of the meals and the acceptability of the intervention in preparation for an 8-week RCT in the future, which will investigate whether a healthy Nordic diet improves depressive symptoms in individuals with major depressive disorder, and associated biological mechanisms. Depressed (n = 10) and non-depressed (n = 6) women and men were randomized to receive either a healthy Nordic diet (ND) or a control diet (CD) for 8 days. Participants were blinded to their diet allocation and the study hypotheses. Health questionnaires were completed before and after the intervention and, throughout the study, questionnaires assessed participants’ liking for the meals, their sensory properties, adherence, and open-ended feedback. In the ND group, 75% of participants consumed only the provided foods, as instructed, compared to 50% of CD participants. The meals of both diets, on average, received good ratings for liking and sensory properties, though the ND ratings were somewhat higher. Overall, results were positive and informative, indicating that the planned RCT will be feasible and well-accepted, with some proposed modifications.

scholarly journals Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: A Randomized Controlled Pilot Trial

2021 ◽  
Author(s):  
Julia A. Sabet ◽  
Moa S. Ekman ◽  
A. Sofia Lundvall ◽  
Ulf Risérus ◽  
Ulrica Johansson ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Control Diet ◽  
Pilot Trial ◽  
Sensory Properties ◽  
Biological Mechanisms ◽  
Double Blind ◽  
Randomized Controlled ◽  
Nordic Diet ◽  
Treatment Of Depression ◽  
Before And After

Healthy diet interventions have been shown to improve depressive symptoms, but there is a need for randomized controlled trials (RCTs) that are double-blind and investigate biological mechanisms. The primary objectives of this randomized controlled pilot trial were to test the palatability of the meals and acceptability of the intervention in preparation for a future 8-week RCT which will investigate whether a healthy Nordic diet improves depressive symptoms in individuals with major depressive disorder, and associated biological mechanisms. Depressed (n=10) and non-depressed (n=6) women and men were randomized to receive either a healthy Nordic diet (ND) or a control diet (CD) for 8 days. Participants were blinded to diet allocation and study hypotheses. Health questionnaires were completed before and after the intervention, and, throughout the study, questionnaires assessed ratings of liking and sensory properties of the meals, adherence, and open-ended feedback. In the ND group, 75% of participants consumed no non-study foods, compared to 50% of CD participants. The meals of both diets, on average, received good ratings for liking and sensory properties, though the ND ratings were somewhat higher. Overall, results were positive and informative, indicating that the planned RCT will be feasible and well-accepted, with some proposed modifications.

scholarly journals Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial

2014 ◽  
Vol 22 (1) ◽  
pp. 17-20 ◽  
Author(s):  
Miranda A.L. van Tilburg ◽  
Olafur S. Palsson ◽  
Yehuda Ringel ◽  
William E. Whitehead
Keyword(s):  
Irritable Bowel Syndrome ◽  
Pilot Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Irritable Bowel

scholarly journals Synbiotic therapy decreases microbial translocation and inflammation and improves immunological status in HIV-infected patients: a double-blind randomized controlled pilot trial

2012 ◽  
Vol 11 (1) ◽  
Author(s):  
Luz A González-Hernández ◽  
Luis F Jave-Suarez ◽  
Mary Fafutis-Morris ◽  
Karina E Montes-Salcedo ◽  
Luis G Valle-Gutierrez ◽  
...  
Keyword(s):  
Pilot Trial ◽  
Microbial Translocation ◽  
Double Blind ◽  
Immunological Status ◽  
Randomized Controlled

Bosentan for mild pulmonary vascular disease in Asd patients (the BOMPA trial): a double-blind, randomized controlled, pilot trial

2013 ◽  
Vol 168 (5) ◽  
pp. 5081-5082 ◽  
Author(s):  
Alexander Van De Bruaene ◽  
Katrijn Jansen ◽  
Pieter De Meester ◽  
Marion Delcroix ◽  
Jens-Uwe Voigt ◽  
...  
Keyword(s):  
Vascular Disease ◽  
Pilot Trial ◽  
Pulmonary Vascular Disease ◽  
Double Blind ◽  
Randomized Controlled

scholarly journals Effects of visualization of successful revascularization on chest pain and quality of life in chronic coronary syndrome: study protocol for the multi-center, randomized, controlled PLA-pCi-EBO-pilot-trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Michael Wester ◽  
Franziska Koll ◽  
Florian Zeman ◽  
Astrid Dempfle ◽  
Michael Koller ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pilot Trial ◽  
Intervention Group ◽  
Control Group ◽  
Daily Routine ◽  
Coronary Syndrome ◽  
Randomized Controlled ◽  
Before And After ◽  
Stable Cad

Abstract Background Stable coronary artery disease (CAD), recently termed chronic coronary syndrome (CCS), is a highly prevalent disease. Current treatment strategies often include a relevant placebo effect. The hypothesis is that visual angiographic demonstration of the coronary arteries before and after successful percutaneous coronary intervention (PCI) by itself reduces the symptom burden of stable CAD/CCS. Design and methods The PLA-pCi-EBO-pilot-trial is a prospective, multi-center, randomized, controlled investigator-initiated pilot trial to study the effect of visual demonstration of successful PCI on quality of life (QoL) and angina pectoris (AP) in patients with symptomatic stable CAD/CCS. All patients with stable CAD/CCS and successful PCI will be screened. One hundred forty four patients with a frequency of AP ≥ 2/week will be randomized 1:1 stratified for AP frequency > 1/day. The control group will receive the common written procedural report on the procedure. Patients in the intervention group will additionally be given a printout picture of their coronary angiogram both before and after PCI. Primary endpoints are change in the Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6 months after PCI. Secondary endpoints are changes in other SAQ-derived scores and dyspnea (NYHA score) 1 and 6 months after PCI. Discussion The PLA-pCi-EBO-pilot-trial evaluates the effect of visual angiographic result demonstration on disease symptoms and QoL in patients with stable CAD/CCS on top of PCI. A positive outcome of our study would encourage the routine use of angiographic picture demonstration and has thus the potential to change daily routine in the catheterization laboratory. Trial registration German Clinical Trials Register DRKS00017524. Registered on 5 July 2019

scholarly journals Effects of Discontinuation of Drugs Used for Augmentation Therapy on Treatment Outcomes in Depression: A Systematic Review and Meta-analysis

2020 ◽  
Author(s):  
Hideo Kato ◽  
Teruki Koizumi ◽  
Hiroyoshi Takeuchi ◽  
Hideaki Tani ◽  
Masaru Mimura ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Augmentation Therapy ◽  
Double Blind ◽  
Randomized Controlled ◽  
Treatment Of Depression ◽  
Meta Analyses ◽  
Stabilization Period ◽  
Frequent Relapse

Abstract Introduction There has been no consensus on whether and how long add-on drugs for augmentation therapy should be continued in the treatment of depression. Methods Double-blind randomized controlled trials that examined the effects of discontinuation of drugs used for augmentation on treatment outcomes in patients with depression were identified. Meta-analyses were performed to compare rates of study withdrawal due to any reason, study-defined relapse, and adverse events between patients who continued augmentation therapy and those who discontinued it. Results Seven studies were included (n=841 for continuing augmentation therapy; n=831 for discontinuing augmentation therapy). The rate of study withdrawal due to any reason was not significantly different between the 2 groups (risk ratio [RR]=0.86, 95% confidence interval [CI]=0.69–1.08, p=0.20). Study withdrawal due to relapse was less frequent in the continuation group than in the discontinuation group (RR=0.61, 95% CI=0.40–0.92, p=0.02); however, this statistical significance disappeared when one study using esketamine as augmentation was excluded. Analysis of the data from 5 studies that included a stabilization period before randomization found less frequent relapse in the continuation group than in the discontinuation group (RR=0.47, 95% CI=0.36–0.60, p<0.01). This finding was repeated when the esketamine study was excluded. Discussion No firm conclusions could be drawn in light of the small number of studies included. Currently available evidence suggests that add-on drugs, other than esketamine, used for augmentation therapy for depression may be discontinued. This may not be the case for patients who are maintained with augmentation therapy after remission.

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