ESAN III - Energy Sensing in Depression

Medical University of Graz

Status: Active, not recruiting

Conditions: Immunomodulation; Gut Microbiota Modulation; Obesity

Treatments: Other: Control; Other: Carotenoid-rich juice

Study type: Interventional

Funder types: Other

Identifiers

NCT06985381

ESANIII

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 6 patient groups, including a placebo group

Verum Normal Weight Arm

Experimental group

Description:

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

Treatment:

Other: Carotenoid-rich juice

Verum Obesity

Experimental group

Description:

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

Treatment:

Other: Carotenoid-rich juice

Control Normal Weight

Placebo Comparator group

Description:

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

Treatment:

Other: Control

Control Obese

Placebo Comparator group

Description:

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

Treatment:

Other: Control

Verum Depression

Experimental group

Description:

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

Treatment:

Other: Carotenoid-rich juice

Control Depression

Placebo Comparator group

Description:

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

Treatment:

Other: Control