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A whole-food diet and obsessive-compulsive disorder: a pilot study

Evaluating the Impact of Two Whole-Food Diets on Obsessive-Compulsive Disorder in Adults: A Multiple Baseline Pilot Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000983505
Acronym
NOURISH-OCD
Enrollment
45
Registered
2024-08-13
Start date
2024-08-31
Completion date
2025-05-02
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study intends to explore the use of dietary intervention in the management of obsessive-compulsive disorder (OCD). This study uses a non-concurrent multiple baseline design, randomising participants into one of three baseline lengths. There will be a stepped-care approach to the delivery of two dietary interventions; The Whole Diet and The Whole Plus Diet, implemented for 8-weeks each. If participants achieve a clinically significant improvement to their OCD symptoms at the end of the first intervention, The Whole Diet, they will conclude the trial. Those who do not note such improvements will continue to The Whole Plus Diet. It is hypothesized that the dietary interventions used within this study will reduce OCD symptom severity to a clinically meaningful degree, and that participants will be able to meaningfully adhere to both interventions. In terms of diet quality, it is hypothesized that upon entering the trial, participants will be observed to have a diet that is high in ultra-processed foods.

Interventions

Upon entering the study, all participants will be randomly allocated into one of three baseline conditions - 1, 2 or 3 weeks. During these periods, participants will be eating their usual diets and will all be asked to have a blood test to measure for various markers of metabolic health, as well as vitamins and minerals. At the conclusion of the baseline period, all participants will then enter a one-week 'logistics week', in which they will receive materials which will outline all they need to

Upon entering the study, all participants will be randomly allocated into one of three baseline conditions - 1, 2 or 3 weeks. During these periods, participants will be eating their usual diets and will all be asked to have a blood test to measure for various markers of metabolic health, as well as vitamins and minerals. At the conclusion of the baseline period, all participants will then enter a one-week 'logistics week', in which they will receive materials which will outline all they need to know about the dietary intervention they are about to commence at the end of the logistics week, providing them time to prepare. Therefore, they will be required to go shopping for the necessary foods that will fit within the dietary interventions. There are two dietary interventions that will be used in this study; The Whole Diet, and The Whole Plus Diet. All participants will commence the first dietary intervention, The Whole Diet, for eight-weeks. At the end of this eight-weeks, if participants haven't experienced a clinically significant reduction in their OCD symptoms, they will continue to The Whole Plus Diet for a further eight-weeks. This will be determined by a clinician-rated outcome psychometric as well as the YBOCS score, which will be obtained from the 8-week check in at the end of the first dietary intervention. For those who do experience a clinically significant improvement in their OCD symptoms, they will conclude the trial after finishing The Whole Diet. The two dietary interventions are outlined below: The Whole Diet The Whole Diet is a whole-foods diet which centres on the removal of ultra-processed foods (UPF) from the diet. In this study, UPF will be defined using the NOVA classification system, which groups foods into four groups based on their level of industrial process (Carlos Augusto Monteiro, Levy, Claro, Castro, & Cannon, 2010). These four groups are unprocessed and minimally processed foods, processed culinary ingredients, processed foods, and ultra-processed foods (Monteiro et al., 2019). Ultra-processed food is defined as being industrial formulations which contain minimal to no whole food, such as chocolate, confectionary, ice-cream and soft drinks (Carlos A Monteiro et al., 2019). UPF are hyper-profitable, hyperpalatable (through the use of additives and flavours), have an extensive marketing budget, and are thus suggested to displace whole food consumption (Carlos A Monteiro et al., 2019). The Whole Plus Diet The Whole Plus Diet is a whole foods anti-inflammatory diet that removes common inflammatory foods including gluten and dairy (Asoudeh et al., 2023; De Punder & Pruimboom, 2013; Junker et al., 2012), as well as alcohol, caffeine, additives and refined sugar. This dietary pattern encourages unlimited consumption of whole foods (with an emphasis on diversity) of fruits, vegetables, meats, legumes, non-gluten containing grains, healthy fats, fermented foods, and herbs and spices. The Whole Plus Diet also allows ‘healthy treats’ including dark chocolate, honey and maple syrup. This diet is a modified Paleo diet (Cordain, 2002), and is based on the principles of the NOVA classification group one (whole, unprocessed foods) (Carlos Augusto Monteiro et al., 2010). It is also supported by research that has explored biological mechanisms that underpin the pathogenesis of OCD and other psychopathologies including inflammation (Gerentes, Pelissolo, Rajagopal, Tamouza, & Hamdani, 2019), metabolic health (Khalkhali, Rasekh, Eslamdoust-Siahestalkhi, Farrahi, & Zare, 2023) and gut dysbiosis (Turna et al., 2020) and foods that can promote these pathways. Research exploring OCD has indicated that the removal of gluten (Rodrigo et al., 2018) and foods high in free glutamate (Holton & Cotter, 2018) could be beneficial. Adherence to dietary intervention will be monitored by the participant being prompted 3-times weekly to send in a day of photos of their food, AI will be utilised to support us in determining the level of adherence. They will also complete two measures of self-efficacy for adherence to the diet.

Sponsors

Sophia Dawson
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants must be aged 18 years and over, and have a diagnosis of OCD from a medical doctor, psychologist or psychiatrist. Participants will also be required to score greater than or equal to 16 on the Yale Brown Obsessive Compulsive Scale (YBOCS), indicating moderate to severe symptoms of OCD. As the study is recruiting participants from all over New Zealand and will be run virtually, it is imperative that all participants have internet access. Participants will be asked not to make any new treatment or any new lifestyle changes over the course of the study. This would include starting psychological treatment/ counselling, new exercise habits and/or other dietary changes aside from the ones recommended within this study.

Exclusion criteria

Participants will be excluded from the study if they have a diagnosis of any of the following psychiatric conditions: personality disorders, eating disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder, or a substance abuse disorder. These conditions have been excluded due to their potential of disrupting participant compliance. Participants will also be excluded from the study if they are unwilling to make dietary changes or unwilling to attend follow up appointments. If participants are currently receiving psychological therapy, they will be advised that they can take part in the trial once their therapy has concluded. Participants are able to take part in this study if they are currently taking psychiatric medications; however, it is important that they have been taking these for at least 6 months prior to commencing the trial.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026