ObesityNCT06985381

ESAN III - Energy Sensing in Depression

A study testing Carotenoid-rich juice in people with Obesity and Gut Microbiota Modulation, run by Medical University of Graz at 1 site in Austria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Obesity, Gut Microbiota Modulation, Immunomodulation
What is being tested?: Carotenoid-rich juice
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteAustria
Study dates: 13 Mar 2024to Jan 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 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Socio-demographic criteria:
Gender: female
Age: 18-65 years
Confirmation of study participation:
Received information on the aims, methods, anticipated benefits, potential risks, and entailed discomforts of the study
Signed declaration of consent

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Subgroup of depressive patients:
Diagnosis of depression according to the ICD-10 criteria
Diagnosis confirmed by an experienced psychiatrist
Subgroup of normal weight participants:
WHO criteria for normal weight (Body Mass Index [BMI] 18.5-24.99 kg/m²)
Subgroup of obese participants:
WHO criteria for obesity (BMI > 30.0 kg/m²)

Who cannot join

Formal criteria:
Lack of informed consent
Health criteria:
Alcohol or drug abuse
Acute or chronic diseases or infections (including cancer, fever, pneumological or renal disorders, cardiovascular disease, hematopoietic disorders)
Digestive disorders (including fructose intolerance, inflammatory bowel disease, irritable bowel syndrome)

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Treatment that may have influenced the microbiome (including antibiotic or antifungal treatment within the previous two months, and daily or irregular intake of prebiotics or probiotics within the previous two months; the intake of yogurt and dairy products is permitted)
History of gastrointestinal surgery (other than appendectomy)
Psychiatric disorders (schizophrenia, dementia, bipolar disorder)
Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical Universtiy of Graz
Graz, Styria, 8010

Other trials in Austria

About this study

Official title: ESAN III - Energy Sensing in Depression Effects of Daucus Carota Subsp. Sativus on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls

The purpose of this study is to assess the effects of carotenoids from natural carrot juice on the immune system. Therefore, the study aims to distinguish the effects of natural juices that are rich in phytonutrients such as carotenoids in healthy and depressive individuals, to explore their potential use in therapeutic settings. The consumption of natural fruit juices rich in polyphenols and carotenoids serves as a model for a vegetarian diet, due to the increased micronutrient density derived from plant-based foods. The results obtained may provide preliminary explanatory models for the beneficial effects of a vegetarian diet.

It is hypothesized that the consumption of a natural carotenoid-rich juice alters the expression of regulatory T cells-specific immune cells that contribute to immunomodulation. Furthermore, beneficial changes in the gut microbiome, metabolome, and nutritional status are expected.

This study was registered retrospectively (after recruitment had started) on ClinicalTrials.gov.

Conditions: Obesity, Gut Microbiota Modulation, Immunomodulation
Being tested: Carotenoid-rich juice, Control
Keywords: Carotenoids, Antioxidant effects, Micronutrient absorption, In-vitro digestion, Intervention study, Nutrition, Natural juice
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carotenoid-rich juiceOther
The intervention is based on the additional consumption of 200 ml natural carotneoid-rich juice a day for a period of six weeks. The participants are asked to drink the natural and commercially available juice in addition to their regular diet. Further, they are asked not to change their diets and lifestyle behaviour during the intervention.
ControlOther
Participants assigned to the control group are asked to drink additional 200ml of water a day to control liquid intake.

Study groups in NCT06985381
Study group	Role	What they receive
Verum Normal Weight Arm	Experimental	Normal weight participants receiving carotenoid-rich juice for 6 weeks. Receives: Other: Carotenoid-rich juice
Verum Obesity	Experimental	Obese (BMI > 30mg/m2) participants receiving carotenoid-rich juice for 6 weeks Receives: Other: Carotenoid-rich juice
Control Normal Weight	Placebo comparator	Normal weight participants receiving control drink (water) for 6 weeks. Receives: Other: Control
Control Obese	Placebo comparator	Obese participants receiving control drink (water) for 6 weeks. Receives: Other: Control
Verum Depression	Experimental	Depressive participants receiving carotenoid-rich natural juice (verum) (n=20). Receives: Other: Carotenoid-rich juice
Control Depression	Placebo comparator	Depressive participants receiving water (control) (n=20). Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of baseline regulatory T cells (Tregs) at week 6 (after the intervention) and after a wash-out period at week 12.
Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. Regulatory T cells (Treg) will be quantified using multiparameter flow cytometry. Monoclonal antibodies specific for surface markers such as CD3, CD4, CD45RA, CD39 and CD25 will be combined with intracellular anti-Foxp3 for the identification of human Treg.
Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. The assessment of Tregs after 12 weeks aims to identify any persisting effects of the intervention.
Measured: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.

Secondary outcomes (3)

Effect of carotenoid-rich juice consumption on gut microbiota composition, assessed by changes in alpha diversity (Shannon Index) between intervention and control groups.
Measured: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
Change in plasma carotenoid concentration following carotenoid-rich juice consumption, compared between intervention and control groups.
Carotenoid plasma concentration is quantified by High-Performance Liquid Chromatography (HPLC).
Measured: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
Change in skin carotenoid levels (measured non-invasively), following carotenoid-rich juice consumption, compared between intervention and control groups.
Skin carotenoid score is determined on an arbitrary scale non-invasively by spectroscopic devices (Veggimeter and Biozoom). A higher score indicates higher carotenoid content stored in the skin (Score Ranges: Biozoom 0-12M; Veggimeter 0-800).
Measured: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 2024Jan 2026

First posted22 May 2025
Study start13 Mar 2024
Primary completionJan 2026 (estimated)
Study completionJan 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The present placebo-controlled, randomized, open, prospective, monocentric study can be classified as a "food product study" (comparison between in trade available carotenoid-rich juice and a placebo). Six study groups are designated: Group VN = normal weight participants receiving carotenoid-rich juice ("verum") (n=20) Group VA = adipose participants receiving carotenoid-rich juice ("verum") (n=20) Group VD = depressive patients receiving carotenoid-rich juice ("verum") (n=20) Group CN = normal weight participants receiving water (control) (n=20) Group CA = adipose participants receiving water (control) (n=20) Group CD = depressive patients receiving water (control) (n=20)
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06985381
Sponsor's protocol ID: ESANIII
Status last verified: Jun 2025
First submitted: 2 May 2025
Last updated: 27 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Morkl S, Lackner S, Muller W, Gorkiewicz G, Kashofer K, Oberascher A, Painold A, Holl A, Holzer P, Meinitzer A, Mangge H, Holasek S. Gut microbiota and body composition in anorexia nervosa inpatients in comparison to athletes, overweight, obese, and normal weight controls. Int J Eat Disord. 2017 Dec;50(12):1421-1431. doi: 10.1002/eat.22801. Epub 2017 Nov 13.
PubMed 29131365
Shanahan F, van Sinderen D, O'Toole PW, Stanton C. Feeding the microbiota: transducer of nutrient signals for the host. Gut. 2017 Sep;66(9):1709-1717. doi: 10.1136/gutjnl-2017-313872. Epub 2017 Jun 29.
PubMed 28663354
Kim YS, Sayers TJ, Colburn NH, Milner JA, Young HA. Impact of dietary components on NK and Treg cell function for cancer prevention. Mol Carcinog. 2015 Sep;54(9):669-78. doi: 10.1002/mc.22301. Epub 2015 Apr 1.
PubMed 25845339
Kim W, Lee H. Advances in nutritional research on regulatory T-cells. Nutrients. 2013 Oct 28;5(11):4305-15. doi: 10.3390/nu5114305.
PubMed 24169507
De Rosa V, Galgani M, Santopaolo M, Colamatteo A, Laccetti R, Matarese G. Nutritional control of immunity: Balancing the metabolic requirements with an appropriate immune function. Semin Immunol. 2015 Sep;27(5):300-9. doi: 10.1016/j.smim.2015.10.001. Epub 2015 Oct 29.
PubMed 26527507

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ESAN III - Energy Sensing in Depression Effects of Daucus Carota Subsp. Sativus on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls
ClinicalTrials.gov ID: NCT06985381
Acronym / sponsor ID: ESANIII
Conditions: Obesity, Gut Microbiota Modulation, Immunomodulation
Keywords: Carotenoids, Antioxidant effects, Micronutrient absorption, In-vitro digestion, Intervention study, Nutrition, Natural juice
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Medical University of GrazUniversity, hospital or other
Study start: 13 Mar 2024 (actual)
Primary completion: Jan 2026 (estimated)
Study completion: Jan 2026 (estimated)
First posted: 22 May 2025 (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 study was registered retrospectively (after recruitment had started) on ClinicalTrials.gov.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
Model description: The present placebo-controlled, randomized, open, prospective, monocentric study can be classified as a "food product study" (comparison between in trade available carotenoid-rich juice and a placebo). Six study groups are designated: Group VN = normal weight participants receiving carotenoid-rich juice ("verum") (n=20) Group VA = adipose participants receiving carotenoid-rich juice ("verum") (n=20) Group VD = depressive patients receiving carotenoid-rich juice ("verum") (n=20) Group CN = normal weight participants receiving water (control) (n=20) Group CA = adipose participants receiving water (control) (n=20) Group CD = depressive patients receiving water (control) (n=20)

Arm	Type	Receives
Verum Normal Weight Arm	Experimental	Other: Carotenoid-rich juiceNormal weight participants receiving carotenoid-rich juice for 6 weeks.
Verum Obesity	Experimental	Other: Carotenoid-rich juiceObese (BMI > 30mg/m2) participants receiving carotenoid-rich juice for 6 weeks
Control Normal Weight	Placebo comparator	Other: ControlNormal weight participants receiving control drink (water) for 6 weeks.
Control Obese	Placebo comparator	Other: ControlObese participants receiving control drink (water) for 6 weeks.
Verum Depression	Experimental	Other: Carotenoid-rich juiceDepressive participants receiving carotenoid-rich natural juice (verum) (n=20).
Control Depression	Placebo comparator	Other: ControlDepressive participants receiving water (control) (n=20).

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Gender: female
Age: 18-65 years
Received information on the aims, methods, anticipated benefits, potential risks, and entailed discomforts of the study
Signed declaration of consent
Diagnosis of depression according to the ICD-10 criteria

Key exclusion criteria (10 listed)

Lack of informed consent
Alcohol or drug abuse
Acute or chronic diseases or infections (including cancer, fever, pneumological or renal disorders, cardiovascular disease, hematopoietic disorders)
Digestive disorders (including fructose intolerance, inflammatory bowel disease, irritable bowel syndrome)
Treatment that may have influenced the microbiome (including antibiotic or antifungal treatment within the previous two months, and daily or irregular intake of prebiotics or probiotics within the previous two months; the intake of yogurt and dairy products is permitted)

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
Carotenoid-rich juiceThe intervention is based on the additional consumption of 200 ml natural carotneoid-rich juice a day for a period of six weeks. The participants are asked to drink the natural and commercially available juice in addition to their regular diet. Further, they are asked not to change their diets and lifestyle behaviour during the intervention.	Other	Verum Depression, Verum Normal Weight Arm, Verum Obesity
ControlParticipants assigned to the control group are asked to drink additional 200ml of water a day to control liquid intake.	Other	Control Depression, Control Normal Weight, Control Obese

Primary outcome

Change of baseline regulatory T cells (Tregs) at week 6 (after the intervention) and after a wash-out period at week 12.
Time frame: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. Regulatory T cells (Treg) will be quantified using multiparameter flow cytometry. Monoclonal antibodies specific for surface markers such as CD3, CD4, CD45RA, CD39 and CD25 will be combined with intracellular anti-Foxp3 for the identification of human Treg. Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. The assessment of Tregs after 12 weeks aims to identify any persisting effects of the intervention.

3 secondary outcomes

Effect of carotenoid-rich juice consumption on gut microbiota composition, assessed by changes in alpha diversity (Shannon Index) between intervention and control groups.
Time frame: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
Change in plasma carotenoid concentration following carotenoid-rich juice consumption, compared between intervention and control groups.
Time frame: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
Change in skin carotenoid levels (measured non-invasively), following carotenoid-rich juice consumption, compared between intervention and control groups.
Time frame: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.

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 27 Jun 2025.
Background: PubMed 29131365Morkl S, Lackner S, Muller W, Gorkiewicz G, Kashofer K, Oberascher A, Painold A, Holl A, Holzer P, Meinitzer A, Mangge H, Holasek S. Gut microbiota and body composition in anorexia nervosa inpatients in comparison to athletes, overweight, obese, and normal weight controls. Int J Eat Disord. 2017 Dec;50(12):1421-1431. doi: 10.1002/eat.22801. Epub 2017 Nov 13.
Background: PubMed 28663354Shanahan F, van Sinderen D, O'Toole PW, Stanton C. Feeding the microbiota: transducer of nutrient signals for the host. Gut. 2017 Sep;66(9):1709-1717. doi: 10.1136/gutjnl-2017-313872. Epub 2017 Jun 29.
Background: PubMed 25845339Kim YS, Sayers TJ, Colburn NH, Milner JA, Young HA. Impact of dietary components on NK and Treg cell function for cancer prevention. Mol Carcinog. 2015 Sep;54(9):669-78. doi: 10.1002/mc.22301. Epub 2015 Apr 1.
Background: PubMed 24169507Kim W, Lee H. Advances in nutritional research on regulatory T-cells. Nutrients. 2013 Oct 28;5(11):4305-15. doi: 10.3390/nu5114305.
Background: PubMed 26527507De Rosa V, Galgani M, Santopaolo M, Colamatteo A, Laccetti R, Matarese G. Nutritional control of immunity: Balancing the metabolic requirements with an appropriate immune function. Semin Immunol. 2015 Sep;27(5):300-9. doi: 10.1016/j.smim.2015.10.001. Epub 2015 Oct 29.

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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.

Sandra Holasek, Prof principal investigator

Medical University of Graz

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Carotenoid-rich juice in people with Obesity and Gut Microbiota Modulation, run by Medical University of Graz at 1 site in Austria.

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 13 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: under way, not looking for participants, as of the sponsor's last update on 27 Jun 2025. 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 Austria. 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?

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?

Change of baseline regulatory T cells (Tregs) at week 6 (after the intervention) and after a wash-out period at week 12. (time frame: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.). 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 NCT06985381, which also lists 5 linked publications.

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 27 Jun 2025.