ESAN III - Energy Sensing in Depression

NCT06985381 | Active Not Recruiting

• 1 other identifier: ESANIII
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Carotenoids; Antioxidant effects; Micronutrient absorption; In-vitro digestion; Intervention study; Nutrition; Natural juice

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.

Other Outcomes (1)

• Change in depressive symptom severity, as measured by the Beck Depression Inventory-II (BDI-II), from baseline to week 6.

  From enrollment (baseline) to the end of intervention at 6 weeks.

Study Arms (6)

Verum Normal Weight Arm

EXPERIMENTAL

Normal weight participants receiving carotenoid-rich juice for 6 weeks.

Other: Carotenoid-rich juice

Verum Obesity

EXPERIMENTAL

Obese (BMI \> 30mg/m2) participants receiving carotenoid-rich juice for 6 weeks

Other: Carotenoid-rich juice

Control Normal Weight

PLACEBO COMPARATOR

Normal weight participants receiving control drink (water) for 6 weeks.

Other: Control

Control Obese

PLACEBO COMPARATOR

Obese participants receiving control drink (water) for 6 weeks.

Other: Control

Verum Depression

EXPERIMENTAL

Depressive participants receiving carotenoid-rich natural juice (verum) (n=20).

Other: Carotenoid-rich juice

Control Depression

PLACEBO COMPARATOR

Depressive participants receiving water (control) (n=20).

Other: Control

Interventions

Carotenoid-rich juice OTHER

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.

Verum Depression; Verum Normal Weight Arm; Verum Obesity

Control OTHER

Participants assigned to the control group are asked to drink additional 200ml of water a day to control liquid intake.

Control Depression; Control Normal Weight; Control Obese

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical Universtiy of Graz

Graz, Styria, 8010, Austria

Location

Related Publications (5)

• 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.

  PMID: 29131365 BACKGROUND

• 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.

  PMID: 28663354 BACKGROUND

• 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.

  PMID: 25845339 BACKGROUND

• Kim W, Lee H. Advances in nutritional research on regulatory T-cells. Nutrients. 2013 Oct 28;5(11):4305-15. doi: 10.3390/nu5114305.

  PMID: 24169507 BACKGROUND

• 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.

  PMID: 26527507 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Holasek, Prof

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 22, 2025
• Study Start: March 13, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

AU (1)