Clinical trial NCT06985381: ESAN III - Energy Sensing in Depression
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Gut Microbiota Modulation
Immunomodulation
Keywords: Carotenoids
Antioxidant effects
Micronutrient absorption
In-vitro digestion
Intervention study
Nutrition
Natural juice
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

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.


Eligibility criteria: INCLUSION CRITERIA

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)

EXCLUSION CRITERIA

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

Primary outcomes:
measure: Change of baseline regulatory T cells (Tregs) at week 6 (after the intervention) and after a wash-out period at week 12.
timeFrame: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
Secondary outcomes:
measure: Effect of carotenoid-rich juice consumption on gut microbiota composition, assessed by changes in alpha diversity (Shannon Index) between intervention and control groups.
timeFrame: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
measure: Change in plasma carotenoid concentration following carotenoid-rich juice consumption, compared between intervention and control groups.
timeFrame: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
measure: Change in skin carotenoid levels (measured non-invasively), following carotenoid-rich juice consumption, compared between intervention and control groups.
timeFrame: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
Other outcomes:
measure: Change in depressive symptom severity, as measured by the Beck Depression Inventory-II (BDI-II), from baseline to week 6.
timeFrame: From enrollment (baseline) to the end of intervention at 6 weeks.
Locations:
city: Graz
country: Austria
facility: Medical Universtiy of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Sandra Holasek, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Kim W, Lee H. Advances in nutritional research on regulatory T-cells. Nutrients. 2013 Oct 28;5(11):4305-15. doi: 10.3390/nu5114305.
citation: 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.