Obesity Trial, Recruiting NCT06621394 Sponsor: University Hospital Tuebingen Condition: Obesity
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Obesity Trial, Recruiting

NCT06621394
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who have been clinically diagnosed with major depression
  • People with at least moderate depression severity, as measured by a standard depression questionnaire (BDI-II score of 20 or higher)
  • People with obesity, defined as a body mass index (BMI) of 30 or higher
  • People whose antidepressant medication and/or therapy has not changed in type, dose, or frequency for at least four weeks before the trial and who are able to keep it stable during the trial
  • People who currently follow a Mediterranean-style diet only to a low degree, based on a standard diet score (confirm with trial site)
  • People who currently practise mindful eating only to a low degree, based on a standard mindful eating score (confirm with trial site)

Who may not be able to join:

  • People with gut or digestive conditions that would interfere with the diet-based parts of the trial, such as irritable bowel syndrome, previous weight-loss (bariatric) surgery, or bowel cancer
  • People with metabolic conditions that would strongly affect the intervention, such as type 1 diabetes or chronic kidney disease
  • People with severe food allergies or intolerances that would prevent them from following the trial diet
  • People who have a current diagnosis of bipolar disorder, an eating disorder, a personality disorder, or psychosis
  • People who have taken antibiotics in the last three months, or who are currently misusing substances
  • People who are pregnant or breastfeeding
  • People who are currently experiencing thoughts of suicide
  • People who are unable to participate in or complete the study questionnaires

Note — this trial also includes a separate group of 32 healthy volunteers for gut microbiome testing only.

Who might be able to join as a healthy volunteer:

  • Adults aged 18 or older
  • People with a BMI between 20 and 30

Who may not be able to join as a healthy volunteer:

  • People with depression or other psychological conditions, including bipolar disorder, eating disorders, personality disorders, or psychosis
  • People who already follow a Mediterranean-style diet to a high degree (confirm with trial site)
  • People who already practise mindful eating to a high degree (confirm with trial site)
  • People with gut or digestive conditions, or metabolic conditions, such as irritable bowel syndrome, previous weight-loss surgery, bowel cancer, or type 1 diabetes
  • People who have taken antibiotics in the last three months, or who are currently misusing substances
  • People who are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +4971181013764

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University Hospital Tuebingen
Registry
ClinicalTrials.gov
Start date
5 November 2024
Est. completion
1 March 2025

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Depression severity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov