ObesityMINDGUTNCT06374407
The MIND-GUT Digital Pilot Intervention Study
A study testing Dietary intervention based on the MIND diet in people with Obesity and Depressive Symptoms, run by University of Skövde at 1 site in Sweden.
Trial summary
This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Depressive Symptoms, Anxiety
- What is being tested?
- Dietary intervention based on the MIND diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 30- 50;
- BMI ≥ 30 kg/m2;
- stable physical activity;
- one person per household;
- commitment to full protocol.
Who cannot join
- use of psychiatric medications (e.g., serotonin reuptake inhibitors);
- use of weight loss medications (GLP-1 receptor agonists);
- food allergies affecting adherence to the MIND diet;
- diagnosis of eating disorders;
- diagnosis of diabetes;
- diagnosis of polycystic ovary syndrome;
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- sensory deficits (e.g., COVID-19-induced loss of taste/smell);
- antibiotic use during the latest 3 months;
- participation in another study;
- language understanding limitations (i.e., not able to understand either Swedish or English); - coeliac/inflammatory bowel disease;
- planned weight management program within three months;
- pregnancy;
- lactation;
- menopause.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploring the Interplay Between Diet, Obesity, Mental Health, and the Gut Microbiome. The MIND-GUT Digital Pilot Intervention Study.
This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.
Read the detailed description
Objective of the Pilot Study and Study Design:
This 12-week randomized pilot intervention study aims to assess the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese individuals aged 30-50.
Participant Recruitment and Randomization:
Participants aged 30-50, excluding those with specific medical conditions such as psychiatric medication use, food allergies affecting diets, eating disorders, diabetes, polycystic ovary syndrome, sensory deficits, recent antibiotic use, participation in other studies, language limitations, coeliac/inflammatory bowel disease, planned weight management within 3 months, and pregnant/lactating/post-menopausal women, will be recruited for the study. Randomization will be conducted to assign eligible participants to either an intervention or control group using a meal planning smartphone app.
Clinical Assessments:
Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections.
Study Endpoints:
The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity.
Statistical Analyses:
Statistical analyses will evaluate the study feasibility, intervention effects on body weight and mental health changes, and the potential mediating roles of these effects by the gut microbiome.
Implications and Future Plans:
This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.
- Conditions
- Obesity, Depressive Symptoms, Anxiety, Stress, Eating Habit, Dysbiosis
- Being tested
- Dietary intervention based on the MIND diet
- Keywords
- mental health, obesity, mind gut diet, gut microbiome
- Medical subject headings
- Obesity, Depression, Anxiety Disorders, Feeding Behavior, Dysbiosis, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention based on the MIND dietBehavioural
A 12-week pilot randomized controlled trial (RCT) involving N=126 obese participants (1:1 gender ratio) to assess protocol feasibility, including recruitment, retention, compliance, physical examinations, and gut sample collection. Sample size, calculated by a statistician, expects a 5% body weight change at follow-up (std. dev. 10%). We chose a 12-week duration for this pilot study to allow sufficient time to observe significant changes in both body weight and mental health.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group comprises participants who do not receive the specific Mind diet intervention but undergo the same procedures as the intervention group, including weighing at the beginning and end of the study, completing identical questionnaires, and providing fecal samples at recruitment and follow-up. They will also use the same meal-planning app as the intervention group. Receives: Behavioral: Dietary intervention based on the MIND diet |
| Intervention group | Experimental | The intervention group consists of participants who receive the Mind diet intervention. Like the control group, they will be weighed at the start and end of the study, answer the same questionnaires, and provide fecal samples at recruitment and follow-up. Additionally, they will use the same meal-planning app as the control group, but their dietary pattern will be based on the Mind diet. Receives: Behavioral: Dietary intervention based on the MIND diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program retention
Evaluation of participants' continued engagement in the program over time i.e., % of individuals completing the second and third 24h diet recall and % of participants returning to the second visit at the end of the intervention.
Measured: 12 weeks
Adherence
Measurement of participants' compliance with the assigned diet and program through 24h recall interviews, assessed comparing reported intake frequencies of each food group with the recommended intake frequencies according to the principles of the MIND diet.
Measured: 12 weeks
Acceptability
Assessment of participants' experience of the program through qualitative interviews, focusing in particular on: Perception of and experience with the intervention, intervention components (dietary plans, use of the app, etc.), factors influencing participants' engagement, perceived impact on behavior and well-being, interaction with the staff, suggestions for improvement.
Measured: 12 weeks
Study effectiveness: change in eating attitudes at follow-up
Comparison of a score calculated after administration of the EAT-26 questionnaire at baseline vs. follow-up. The EAT-26 comprises three subscales, namely, Dieting, Bulimia and Food Preoccupation, and Oral Control. Higher scores correspond to a worse outcome.
Measured: 12 weeks
Study effectiveness: change in stress levels at follow-up
Comparison of PSS-4 questionnaire at baseline vs. follow-up. The PSS total score is calculated by reverse-coding the positive items and summing the scores for all items. The total scores range from 0 to 56, from 0 to 40, and from 0 to 16 for the PSS-14, PSS-10, and PSS-4, respectively. A higher score indicates more perceived stress.
Measured: 12 weeks
Study effectiveness: change in depression symptoms at follow-up
Comparison of PHQ-9 questionnaire at baseline vs. follow-up. The PHQ-9 is a tool to assist clinicians in identifying and diagnosing major depression. It has a maximum score of 27. Higher scores correspond to worst outcomes in terms of depression symtoms.
Measured: 12 weeks
Study effectiveness: change in anxiety symtoms at follow-up
Comparison of GAD-7 questionnaire at baseline vs. follow-up. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting worst outcomes in terms of anxiety severity.
Measured: 12 weeks
Study effectiveness: change in body weight at follow-up
Comparison of body weight at baseline vs. follow-up
Measured: 12 weeks
Study effectiveness: change in % total fat mass at follow-up
Comparison of body % total fat mass at baseline vs. follow-up
Measured: 12 weeks
Study effectiveness: change in % visceral fat mass at follow-up
Comparison of body % visceral fat at baseline vs. follow-up
Measured: 12 weeks
Study effectiveness: change in waist circumference at follow-up
Comparison of waist circumference at baseline vs. follow-up
Measured: 12 weeks
Study effectiveness: change in hip circumference at follow-up
Comparison of hip circumference at baseline vs. follow-up
Measured: 12 weeks
Study effectiveness: change in microbiome variety at follow-up
Comparison of number and types of species at baseline vs. follow-up.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We plan to randomly assign participants to either the intervention or control group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Skövde
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center, Albert Einstein College of Medicine, Göteborg University, Uppsala University, Kristianstad University, University of Pavia, The Food Scientist AB (Sweden)
- Responsible party
- Principal investigator, Gianluca Tognon, University of Skövde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374407
- Sponsor's protocol ID
- GT-001
- Acronym
- MINDGUT
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Interplay Between Diet, Obesity, Mental Health, and the Gut Microbiome. The MIND-GUT Digital Pilot Intervention Study.
- ClinicalTrials.gov ID
- NCT06374407
- Acronym / sponsor ID
- MINDGUT / GT-001
- Conditions
- Obesity, Depressive Symptoms, Anxiety, Stress, Eating Habit, Dysbiosis
- Keywords
- mental health, obesity, mind gut diet, gut microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of SkövdeUniversity, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center, Albert Einstein College of Medicine, Göteborg University, Uppsala University, Kristianstad University, University of Pavia, The Food Scientist AB (Sweden)
- Study start
- Jun 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.
Detailed description
Objective of the Pilot Study and Study Design:
This 12-week randomized pilot intervention study aims to assess the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese individuals aged 30-50.
Participant Recruitment and Randomization:
Participants aged 30-50, excluding those with specific medical conditions such as psychiatric medication use, food allergies affecting diets, eating disorders, diabetes, polycystic ovary syndrome, sensory deficits, recent antibiotic use, participation in other studies, language limitations, coeliac/inflammatory bowel disease, planned weight management within 3 months, and pregnant/lactating/post-menopausal women, will be recruited for the study. Randomization will be conducted to assign eligible participants to either an intervention or control group using a meal planning smartphone app.
Clinical Assessments:
Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections.
Study Endpoints:
The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity.
Statistical Analyses:
Statistical analyses will evaluate the study feasibility, intervention effects on body weight and mental health changes, and the potential mediating roles of these effects by the gut microbiome.
Implications and Future Plans:
This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We plan to randomly assign participants to either the intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Dietary intervention based on the MIND dietThe control group comprises participants who do not receive the specific Mind diet intervention but undergo the same procedures as the intervention group, including weighing at the beginning and end of the study, completing identical questionnaires, and providing fecal samples at recruitment and follow-up. They will also use the same meal-planning app as the intervention group. |
| Intervention group | Experimental | Behavioral: Dietary intervention based on the MIND dietThe intervention group consists of participants who receive the Mind diet intervention. Like the control group, they will be weighed at the start and end of the study, answer the same questionnaires, and provide fecal samples at recruitment and follow-up. Additionally, they will use the same meal-planning app as the control group, but their dietary pattern will be based on the Mind diet. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 30- 50;
- BMI ≥ 30 kg/m2;
- stable physical activity;
- one person per household;
- commitment to full protocol.
Key exclusion criteria (14 listed)
- use of psychiatric medications (e.g., serotonin reuptake inhibitors);
- use of weight loss medications (GLP-1 receptor agonists);
- food allergies affecting adherence to the MIND diet;
- diagnosis of eating disorders;
- diagnosis of diabetes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention based on the MIND dietA 12-week pilot randomized controlled trial (RCT) involving N=126 obese participants (1:1 gender ratio) to assess protocol feasibility, including recruitment, retention, compliance, physical examinations, and gut sample collection. Sample size, calculated by a statistician, expects a 5% body weight change at follow-up (std. dev. 10%). We chose a 12-week duration for this pilot study to allow sufficient time to observe significant changes in both body weight and mental health. | Behavioural | Control group, Intervention group |
Primary outcome
Program retention
Time frame: 12 weeks
Evaluation of participants' continued engagement in the program over time i.e., % of individuals completing the second and third 24h diet recall and % of participants returning to the second visit at the end of the intervention.
Adherence
Time frame: 12 weeks
Measurement of participants' compliance with the assigned diet and program through 24h recall interviews, assessed comparing reported intake frequencies of each food group with the recommended intake frequencies according to the principles of the MIND diet.
Acceptability
Time frame: 12 weeks
Assessment of participants' experience of the program through qualitative interviews, focusing in particular on: Perception of and experience with the intervention, intervention components (dietary plans, use of the app, etc.), factors influencing participants' engagement, perceived impact on behavior and well-being, interaction with the staff, suggestions for improvement.
Study effectiveness: change in eating attitudes at follow-up
Time frame: 12 weeks
Comparison of a score calculated after administration of the EAT-26 questionnaire at baseline vs. follow-up. The EAT-26 comprises three subscales, namely, Dieting, Bulimia and Food Preoccupation, and Oral Control. Higher scores correspond to a worse outcome.
Study effectiveness: change in stress levels at follow-up
Time frame: 12 weeks
Comparison of PSS-4 questionnaire at baseline vs. follow-up. The PSS total score is calculated by reverse-coding the positive items and summing the scores for all items. The total scores range from 0 to 56, from 0 to 40, and from 0 to 16 for the PSS-14, PSS-10, and PSS-4, respectively. A higher score indicates more perceived stress.
Study effectiveness: change in depression symptoms at follow-up
Time frame: 12 weeks
Comparison of PHQ-9 questionnaire at baseline vs. follow-up. The PHQ-9 is a tool to assist clinicians in identifying and diagnosing major depression. It has a maximum score of 27. Higher scores correspond to worst outcomes in terms of depression symtoms.
Study effectiveness: change in anxiety symtoms at follow-up
Time frame: 12 weeks
Comparison of GAD-7 questionnaire at baseline vs. follow-up. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting worst outcomes in terms of anxiety severity.
Study effectiveness: change in body weight at follow-up
Time frame: 12 weeks
Comparison of body weight at baseline vs. follow-up
Study effectiveness: change in % total fat mass at follow-up
Time frame: 12 weeks
Comparison of body % total fat mass at baseline vs. follow-up
Study effectiveness: change in % visceral fat mass at follow-up
Time frame: 12 weeks
Comparison of body % visceral fat at baseline vs. follow-up
Study effectiveness: change in waist circumference at follow-up
Time frame: 12 weeks
Comparison of waist circumference at baseline vs. follow-up
Study effectiveness: change in hip circumference at follow-up
Time frame: 12 weeks
Comparison of hip circumference at baseline vs. follow-up
Study effectiveness: change in microbiome variety at follow-up
Time frame: 12 weeks
Comparison of number and types of species at baseline vs. follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention based on the MIND diet in people with Obesity and Depressive Symptoms, run by University of Skövde at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program retention (time frame: 12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.