Anorexia NervosaNCT06064201
The Role of Short-chain Fatty Acids in Malnutrition on Stress, Eating Behavior, and Nutritional State
A study testing Short-chain fatty acids (SCFAs) in people with Anorexia Nervosa, run by KU Leuven at 1 site in Belgium.
Trial summary
This clinical trial aims to test the psychobiological effects of certain substances produced by gut bacteria, known as short-chain fatty acids (SCFAs), in people with anorexia nervosa. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Short-chain fatty acids (SCFAs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants are female.
- Participants are at least 16 years of age.
- Participants are Dutch-speaking.
- Participants meet the diagnostic criteria of anorexia nervosa based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; American Psychiatric Association, 2013). The first time the participant met these criteria was less than seven years ago.
- Participants have a current BMI < 17,5 (kg/m2).
- Participants are on the waiting list for a psychiatric/psychotherapeutic inpatient treatment program with nutritional rehabilitation on the eating disorder ward of the University Psychiatric Hospital Leuven.
- Participants can access a -18°C home freezer for stool storage.
Who cannot join
- Any medical or psychiatric disorder, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
- Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial.
- Substance/alcohol/illegal drug abuse or dependence or evidence for chronic uses of sedatives, drugs and/or sleep medication.
- High caffeine intake (> 1000 ml coffee daily or equivalent quantities of other caffeine-containing substances).
- Use of pre- or probiotics within the last month before the start of the study.
- Use of antibiotics within the last three months before the start of the study.
Show all 10Show fewer
- Pregnancy or intention to become pregnant.
- Previous experience with one of the tasks used in the study.
- Use of antipsychotics
- Use of selective serotonin reuptake inhibitors (SSRIs), oral contraceptives, or other drugs is allowed if patients are on a stable dosage for at least four weeks.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZ/KU Leuven
Leuven, Vlaams Brabant, 3000
Elske Vrieze, MD PhD, +32 16 34 81 46, elske.vrieze@upckuleuven.be
About this study
Official title: The Role of Short-chain Fatty Acids (SCFAs) in Regulating Stress Responses, Eating Behavior, and Nutritional State in Anorexia Nervosa: a Randomized Controlled Trial
This clinical trial aims to test the psychobiological effects of certain substances produced by gut bacteria, known as short-chain fatty acids (SCFAs), in people with anorexia nervosa.
Read the detailed description
Objective This protocol proposes investigating the effects of short-chain fatty acids (SCFAs), produced by gut bacterial fermentation of dietary fiber, as mediators of microbiota-gut-brain interactions on the acute stress response, eating behavior, and nutritional state in malnourished patients with anorexia nervosa (AN). SCFAs have recently been proposed as crucial mediators of the microbiome's effects on the host. Emerging evidence suggests that SCFAs impact human physiology through various physiological pathways and may regulate stress responses and eating behavior.
Method The investigators will conduct a randomized, triple-blind, placebo-controlled trial in 92 AN patients. Patients will receive either a placebo or a mixture of SCFAs (acetate propionate, butyrate) using colon-delivery capsules (CDCs) for six weeks. This clinical trial is an add-on to the standard inpatient psychotherapeutic program focusing on nutritional rehabilitation.
Hypotheses The investigators hypothesize that colonic SCFAs delivery will modulate neuroendocrine, cardiovascular, and subjective responses to an acute laboratory psychosocial stress task. As secondary outcome measures, the investigators will assess alterations in restrictive eating behavior and nutritional status, as reflected by changes in body mass index (BMI). Additionally, the investigators will explore changes in microbiota composition, gastrointestinal symptoms, eating disorder psychopathology, and related comorbidities.
Discussion The findings of this study can enhance our understanding of how gut microbiota-produced metabolites, particularly SCFAs, impact the stress response and eating behavior of individuals with AN. It has the potential to provide essential insights into the complex interplay between the gut, stress system, and eating behavior and facilitate new therapeutic targets for stress-related psychiatric disorders.
- Conditions
- Anorexia Nervosa
- Being tested
- Short-chain fatty acids (SCFAs), Placebo
- Keywords
- anorexia nervosa, short-chain fatty acids, gut-brain axis, microbiota, stress response, eating behavior, gut microbiome, food choice, Trier Social Stress Test, randomized controlled trial
- Medical subject headings
- Anorexia Nervosa, Fractures, Stress, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-chain fatty acids (SCFAs)Other
The SCFAs mixture contains acetate, butyrate, and propionate in a ratio of 60:20:20, and the total daily amount of SCFAs is equivalent to the fermentation of 10g of arabinoxylan oligosaccharides. Participants will be asked to consume these capsules spread at four intervals throughout the day. The nursing staff will distribute the capsules to the participants individually, supervise their intake, and monitor adherence by capsule count.
PlaceboOther
To serve as a placebo, microcrystalline cellulose will be included in the same type of CDCs.
| Study group | Role | What they receive |
|---|---|---|
| Short-chain fatty acids (SCFAs) | Experimental | SCFAs will be delivered directly to the colon using pH-dependent colon delivery capsules (CDCs). Receives: Other: Short-chain fatty acids (SCFAs) |
| Microcrystalline cellulose | Placebo comparator | Placebo capsules Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol response following TSST
Changes in salivary cortisol levels in response to acute laboratory stress (Trier Social Stress Test).
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Restrictive food choices during Food Choice Task
Food choices made under stress are measured through the food choice task, focusing on the proportion of high-fat food items chosen over the reference item.
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Nutritional status (BMI)
Nutritional status of participants determined by calculating Body Mass Index (BMI) from recurrently measured weight
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following the start of the intervention)
Secondary outcomes (14)
Neuroendocrine Measures (salivary alpha amylase)
Salivary alpha-amylase (sAA) levels are measured using salivary samples in response to acute laboratory stress (Trier Social Stress Test).
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Neuroendocrine Measures (ACTH)
Adrenocorticotropic hormone (ACTH) serum levels are measured in response to acute laboratory stress (Trier Social Stress Test).
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective stress in relation to TSST
Participants' subjective subjective stress experience in response to acute laboratory stress is measured using Visual Analog Scales (VAS, scale 0-100), where higher scores indicate higher subjective stress.
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective stress appraisal in relation to TSST
The Primary Appraisal and Secondary Appraisal (PASA) scale assesses various stress-related cognitive processes in anticipation of the TSST. The scale comprises four sub-scales: Threat, Challenge, Outcome Expectancy, and Self-efficacy. The first two address issues related to primary appraisal, and the latter two focus on secondary appraisal. Finally, an overall score for perceived stress can also be calculated from PASA by subtracting the secondary appraisal score from that of primary appraisal. Higher scores reflect a more positive anticipatory cognitive stress appraisal.
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective anxiety in relation to TSST
Participants' subjective experience of anxiety in response to acute laboratory stress is measured using Visual Analog Scales (VAS, scale 0-100). Higher scores indicate a higher subjective anxiety experience.
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective hunger in relation to TSST
Participants' subjective experience of hunger in response to acute laboratory stress is measured using Visual Analog Scales (VAS, scale 0-100). Higher scores indicate higher subjective hunger.
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective appetite in relation to TSST
Participants' subjective experience of appetite in response to acute laboratory stress is measured using Visual Analog Scales (VAS, scale 0-100). Higher scores indicate higher subjective appetite.
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Heart rate response to acute laboratory stress
Physiological measures to acute laboratory stress: measurement of( autonomic nervous system activity) heart rate response (unit: beats per minute) to acute laboratory stress using EmbracePlus wearable wrist device.
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Heart rate variability to acute laboratory stress
Physiological measures to acute laboratory stress: measurement of( autonomic nervous system activity) heart rate variability (unit: milliseconds) to acute laboratory stress using EmbracePlus wearable wrist device.
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Electrodermal activity to acute laboratory stress
Physiological measures to acute laboratory stress: measurement of( autonomic nervous system activity) Electrodermal activity (unit: micro siemens) to acute laboratory stress using EmbracePlus wearable wrist device.
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Self controlled choices during Food Choice Task
The proportion of self-controlled choices, choosing healthy, less tasty foods or not choosing unhealthy, tasty foods during the food choice task
Measured: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Eating Disorder Symptoms
The severity of eating disorder symptoms is evaluated using the Eating Disorder Examination Questionnaire (EDE-Q). The EDE-Q is a 28-item self-report questionnaire adapted from the semi-structured interview, the Eating Disorder Examination (EDE). The questionnaire is designed to assess the range, frequency, and severity of behaviors associated with a diagnosis of an eating disorder. Higher scores indicate more problematic eating behaviors and attitudes.
Measured: Self-reported questionnaires are completed at the baseline visit (at hospital admission and before intervention), three weeks into the intervention, post intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following
Restrained, emotional and external eating behaviour
Restrained, emotional and external eating behaviour is evaluated using the Dutch Eating Behavior Questionnaire (DEBQ). The DEBQ is a 33-item self-report questionnaire to assess three distinct eating behaviors in adults: (1) emotional eating, (2) external eating, and (3) restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.
Measured: Self-reported questionnaires are completed at the baseline visit (at hospital admission and before intervention), three weeks into the intervention, post intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following
Hedonic hunger
Hedonic hunger is evaluated using the Power of Food Scale (PFS). The PFS assesses the psychological impact of living in food-abundant environments. It measures appetite for, rather than consumption of, palatable foods, at three levels of food proximity (food available, food present, and food tasted). The PFS consists of 15 items, rated on a 5-point Likert scale, assessing preoccupation with palatable foods across three distinct but related domains (contributing to three separate subscales of the measure).
Measured: Self-reported questionnaires are completed at the baseline visit (at hospital admission and before intervention), three weeks into the intervention, post intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elske Vrieze, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064201
- Sponsor's protocol ID
- S66404
- Status last verified
- Sep 2023
- First submitted
- 28 Jul 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication will be made available to other researchers with all identifying information removed.
Publications
Quagebeur R, Dalile B, Raes J, Van Oudenhove L, Verbeke K, Vrieze E. The role of short-chain fatty acids (SCFAs) in regulating stress responses, eating behavior, and nutritional state in anorexia nervosa: protocol for a randomized controlled trial. J Eat Disord. 2023 Oct 26;11(1):191. doi: 10.1186/s40337-023-00917-6.
PubMed 37884972
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Short-chain Fatty Acids (SCFAs) in Regulating Stress Responses, Eating Behavior, and Nutritional State in Anorexia Nervosa: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06064201
- Acronym / sponsor ID
- S66404
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, short-chain fatty acids, gut-brain axis, microbiota, stress response, eating behavior, gut microbiome, food choice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Oct 2023 (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 clinical trial aims to test the psychobiological effects of certain substances produced by gut bacteria, known as short-chain fatty acids (SCFAs), in people with anorexia nervosa.
Detailed description
Objective This protocol proposes investigating the effects of short-chain fatty acids (SCFAs), produced by gut bacterial fermentation of dietary fiber, as mediators of microbiota-gut-brain interactions on the acute stress response, eating behavior, and nutritional state in malnourished patients with anorexia nervosa (AN). SCFAs have recently been proposed as crucial mediators of the microbiome's effects on the host. Emerging evidence suggests that SCFAs impact human physiology through various physiological pathways and may regulate stress responses and eating behavior.
Method The investigators will conduct a randomized, triple-blind, placebo-controlled trial in 92 AN patients. Patients will receive either a placebo or a mixture of SCFAs (acetate propionate, butyrate) using colon-delivery capsules (CDCs) for six weeks. This clinical trial is an add-on to the standard inpatient psychotherapeutic program focusing on nutritional rehabilitation.
Hypotheses The investigators hypothesize that colonic SCFAs delivery will modulate neuroendocrine, cardiovascular, and subjective responses to an acute laboratory psychosocial stress task. As secondary outcome measures, the investigators will assess alterations in restrictive eating behavior and nutritional status, as reflected by changes in body mass index (BMI). Additionally, the investigators will explore changes in microbiota composition, gastrointestinal symptoms, eating disorder psychopathology, and related comorbidities.
Discussion The findings of this study can enhance our understanding of how gut microbiota-produced metabolites, particularly SCFAs, impact the stress response and eating behavior of individuals with AN. It has the potential to provide essential insights into the complex interplay between the gut, stress system, and eating behavior and facilitate new therapeutic targets for stress-related psychiatric disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-chain fatty acids (SCFAs) | Experimental | Other: Short-chain fatty acids (SCFAs)SCFAs will be delivered directly to the colon using pH-dependent colon delivery capsules (CDCs). |
| Microcrystalline cellulose | Placebo comparator | Other: PlaceboPlacebo capsules |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Participants are female.
- Participants are at least 16 years of age.
- Participants are Dutch-speaking.
- Participants meet the diagnostic criteria of anorexia nervosa based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; American Psychiatric Association, 2013). The first time the participant met these criteria was less than seven years ago.
- Participants have a current BMI < 17,5 (kg/m2).
Key exclusion criteria (10 listed)
- Any medical or psychiatric disorder, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
- Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial.
- Substance/alcohol/illegal drug abuse or dependence or evidence for chronic uses of sedatives, drugs and/or sleep medication.
- High caffeine intake (> 1000 ml coffee daily or equivalent quantities of other caffeine-containing substances).
- Use of pre- or probiotics within the last month before the start of the study.
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 |
|---|---|---|
| Short-chain fatty acids (SCFAs)The SCFAs mixture contains acetate, butyrate, and propionate in a ratio of 60:20:20, and the total daily amount of SCFAs is equivalent to the fermentation of 10g of arabinoxylan oligosaccharides. Participants will be asked to consume these capsules spread at four intervals throughout the day. The nursing staff will distribute the capsules to the participants individually, supervise their intake, and monitor adherence by capsule count. | Other | Short-chain fatty acids (SCFAs) |
| PlaceboTo serve as a placebo, microcrystalline cellulose will be included in the same type of CDCs. | Other | Microcrystalline cellulose |
Primary outcome
Salivary cortisol response following TSST
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Changes in salivary cortisol levels in response to acute laboratory stress (Trier Social Stress Test).
Restrictive food choices during Food Choice Task
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Food choices made under stress are measured through the food choice task, focusing on the proportion of high-fat food items chosen over the reference item.
Nutritional status (BMI)
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following the start of the intervention)
Nutritional status of participants determined by calculating Body Mass Index (BMI) from recurrently measured weight
14 secondary outcomes
Neuroendocrine Measures (salivary alpha amylase)
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Neuroendocrine Measures (ACTH)
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective stress in relation to TSST
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective stress appraisal in relation to TSST
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective anxiety in relation to TSST
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective hunger in relation to TSST
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Subjective appetite in relation to TSST
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Heart rate response to acute laboratory stress
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Heart rate variability to acute laboratory stress
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Electrodermal activity to acute laboratory stress
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Self controlled choices during Food Choice Task
Time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)
Eating Disorder Symptoms
Time frame: Self-reported questionnaires are completed at the baseline visit (at hospital admission and before intervention), three weeks into the intervention, post intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following
Restrained, emotional and external eating behaviour
Time frame: Self-reported questionnaires are completed at the baseline visit (at hospital admission and before intervention), three weeks into the intervention, post intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following
Hedonic hunger
Time frame: Self-reported questionnaires are completed at the baseline visit (at hospital admission and before intervention), three weeks into the intervention, post intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 37884972Quagebeur R, Dalile B, Raes J, Van Oudenhove L, Verbeke K, Vrieze E. The role of short-chain fatty acids (SCFAs) in regulating stress responses, eating behavior, and nutritional state in anorexia nervosa: protocol for a randomized controlled trial. J Eat Disord. 2023 Oct 26;11(1):191. doi: 10.1186/s40337-023-00917-6.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication will be made available to other researchers with all identifying information removed.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-chain fatty acids (SCFAs) in people with Anorexia Nervosa, run by KU Leuven at 1 site in Belgium.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elske Vrieze, MD PhD (+32 16 34 81 46, elske.vrieze@upckuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary cortisol response following TSST (time frame: Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064201, which also lists 1 linked publication.
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 3 Oct 2023.