Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum Normal Weight Arm | Experimental | Normal weight participants receiving carotenoid-rich juice for 6 weeks. |
|
| Verum Obesity | Experimental | Obese (BMI > 30mg/m2) participants receiving carotenoid-rich juice for 6 weeks |
|
| Control Normal Weight | Placebo Comparator | Normal weight participants receiving control drink (water) for 6 weeks. |
|
| Control Obese | Placebo Comparator | Obese participants receiving control drink (water) for 6 weeks. |
|
| Verum Depression | Experimental | Depressive participants receiving carotenoid-rich natural juice (verum) (n=20). |
|
| Control Depression | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptom severity, as measured by the Beck Depression Inventory-II (BDI-II), from baseline to week 6. | [Range: 0-63; higher scores indicate more severe depressive symptoms.] | From enrollment (baseline) to the end of intervention at 6 weeks. |
INCLUSION CRITERIA
Socio-demographic criteria:
Confirmation of study participation:
Subgroup of depressive patients:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sandra Holasek, Prof | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Universtiy of Graz | Graz | Styria | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29131365 | Background | 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. | |
| 28663354 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Depressive participants receiving water (control) (n=20).
|
|
| Control | Other | Participants assigned to the control group are asked to drink additional 200ml of water a day to control liquid intake. |
|
Carotenoid plasma concentration is quantified by High-Performance Liquid Chromatography (HPLC). |
| 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). | From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12. |
| 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. |
| 25845339 | 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. |
| 24169507 | 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. |
| 26527507 | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |