ESAN II - Energy Sensing in Depression

Obesity Clinical Trial

Official title:

ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05432362
• Other study ID #: ESANII
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: May 2023
• Source: Medical University of Graz
• Contact: Sonja Lackner, Dr.
• Phone: +43 316 385 711 66
• Email: sonja.lackner[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of polyphenols from natural aronia juice on the immune system. Therefore, the study aims to distinguish the effects of natural juices that are rich in phytonutrients such as polyphenols and carotenoids in healthy and depressive subjects in order to use the known positive effects of these food sources in the therapeutic setting. The consumption of natural fruit juices that are rich in polyphenols and carotenoids mirror a model of vegetarian diet due to the increased micronutrient density derived from plant food. Results obtained here can be seen as preliminary explanation models for the beneficial effects of vegetarian diet. It is hypothesized, that the consumption of naturally polyphenol rich aronia juice changes the expression of regulatory T cells, specific cells of the immunesystem that contribute to immunomodulation. Furthermore, beneficial changes in the gut microbiome, the metabolome and the nutritional status are expected in the studied groups. The study was registered retrospectively (after start of recruitment) on Clinicaltrials.gov.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Socio-demographic criteria:

1. Gender: female

2. Age: 18-40 years

2. Confirmation of the study settings

1. receives of information on

• the aims,
• methods,
• anticipated benefits,
• potential risks, and
• entailed discomforts of the study

2. signed declaration of consent

3. Subgroup of depressive patients:

1. diagnosis of depression according to the ICD-10 criteria for depression

2. diagnosed by an experienced psychiatrist

• a structured diagnostic interview
• voluntarily agreement to participate
• signed informed consent

4. Subgroup of normal weight participants:

• WHO criteria for normal weight (body mass index (BMI) 18.5-24.99 kg/m2)

5. Subgroup of obese participants

• WHO criteria for obesity (BMI < 30.0 kg/m2)

Exclusion Criteria:

1. Formal criteria:

• lack of informed consent

2. Health criteria

1. alcohol- or drug abuse

2. major cognitive deficits (which do not allow adequate testing)

• according to Mini Mental Status Examination (MMSE) <20

3. patients which are currently in the locked ward of the clinic

4. acute or chronic diseases or infections within the previous two months

• upper respiratory tract infections
• fever
• chronic inflammatory disorders
• autoimmune-disorders
• blood diseases
• mitochondrial diseases

3. Digestive disorders

1. fructose intolerance

2. history of digestive diseases such as

• inflammatory bowel disease
• irritable bowel syndrome

3. treatment that may has influenced the microbiome

• antibiotic or antifungal treatment within the previous two months
• daily or irregular intake of prebiotics or probiotics within the previous two months (the intake of yoghurt and dairy products are permitted)

4. history of gastrointestinal surgery (other than appendectomy)

4. Pregnancy and period of breastfeeding

Related Conditions & MeSH terms

• Communicable Diseases
• Depression
• Depressive Disorder
• Diet, Healthy
• Immune System Tolerance
• Infections
• Microbial Colonization
• Obesity

Intervention

Other:
• Aronia Juice
The intervention is based an the additional consumption of 200 ml natural juice a day for a period of six weeks. The participants are asked to drink the natural and commercially availabe juice in addition to their regular diet. Further, they are asked not to change their diets and lifestyle behaviour during the intervention.
• Placebo
A beverage is prepared according to a known recipe. It contains macro- and micronutrients in comparable amounts like the aronia juice. It is completely polyphenol free.

Locations

Country	Name	City	State
Austria	Medical Universtiy of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (15)

Abella V, Scotece M, Conde J, Pino J, Gonzalez-Gay MA, Gomez-Reino JJ, Mera A, Lago F, Gomez R, Gualillo O. Leptin in the interplay of inflammation, metabolism and immune system disorders. Nat Rev Rheumatol. 2017 Feb;13(2):100-109. doi: 10.1038/nrrheum.2016.209. Epub 2017 Jan 5. — View Citation

Aguirre L, Fernandez-Quintela A, Arias N, Portillo MP. Resveratrol: anti-obesity mechanisms of action. Molecules. 2014 Nov 14;19(11):18632-55. doi: 10.3390/molecules191118632. — View Citation

Bettelli E, Carrier Y, Gao W, Korn T, Strom TB, Oukka M, Weiner HL, Kuchroo VK. Reciprocal developmental pathways for the generation of pathogenic effector TH17 and regulatory T cells. Nature. 2006 May 11;441(7090):235-8. doi: 10.1038/nature04753. Epub 2006 Apr 30. — View Citation

Chrubasik C, Li G, Chrubasik S. The clinical effectiveness of chokeberry: a systematic review. Phytother Res. 2010 Aug;24(8):1107-14. doi: 10.1002/ptr.3226. — View 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. — View 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. — View 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. — View Citation

Koopman M, El Aidy S; MIDtrauma consortium. Depressed gut? The microbiota-diet-inflammation trialogue in depression. Curr Opin Psychiatry. 2017 Sep;30(5):369-377. doi: 10.1097/YCO.0000000000000350. — View Citation

Meyrel M, Varin L, Detaint B, Mouaffak F. [The intestinal microbiota: A new player in depression?]. Encephale. 2018 Feb;44(1):67-74. doi: 10.1016/j.encep.2017.03.005. Epub 2017 Apr 24. French. — View 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 norma — View Citation

Mullan A, Delles C, Ferrell W, Mullen W, Edwards CA, McColl JH, Roberts SA, Lean ME, Sattar N. Effects of a beverage rich in (poly)phenols on established and novel risk markers for vascular disease in medically uncomplicated overweight or obese subjects: A four week randomized placebo-controlled trial. Atherosclerosis. 2016 Mar;246:169-76. doi: 10.1016/j.atherosclerosis.2016.01.004. Epub 2016 Jan 6. — View Citation

Perez-Perez A, Vilarino-Garcia T, Fernandez-Riejos P, Martin-Gonzalez J, Segura-Egea JJ, Sanchez-Margalet V. Role of leptin as a link between metabolism and the immune system. Cytokine Growth Factor Rev. 2017 Jun;35:71-84. doi: 10.1016/j.cytogfr.2017.03.001. Epub 2017 Mar 4. — View 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. — View Citation

Vauzour D, Rodriguez-Mateos A, Corona G, Oruna-Concha MJ, Spencer JP. Polyphenols and human health: prevention of disease and mechanisms of action. Nutrients. 2010 Nov;2(11):1106-31. doi: 10.3390/nu2111106. Epub 2010 Nov 8. — View Citation

Xue Z, Li D, Yu W, Zhang Q, Hou X, He Y, Kou X. Mechanisms and therapeutic prospects of polyphenols as modulators of the aryl hydrocarbon receptor. Food Funct. 2017 Apr 19;8(4):1414-1437. doi: 10.1039/c6fo01810f. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of baseline metabolome at 6 weeks (after the intervention)	The metabolome can be identified in various biological materials such as blood (EDTA and serum) Metabolites in blood will be analyzed by using 1H-NMR spectra. A non-targeted approach will be applied to characterize a potential shift in the participants' metabolic profile.	Determination at baseline (day 0) and after 6 weeks (after the intervention)
Other	Change of baseline metabolome at 12 weeks (after the 6 weeks intervention and another 6 weeks of wash out)	The metabolome can be identified in various biological materials such as blood (EDTA and serum) Metabolites in blood will be analyzed by using 1H-NMR spectra. A non-targeted approach will be applied to characterize a potential shift in the participants' metabolic profile.The assessment of the change in the metabolome after 12 weeks aims to identify any persisting effects of the intervention.	Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Primary	Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention)	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.	Determination at baseline (day 0) and after 6 weeks (after the intervention)
Primary	Change of baseline regulatory T cells (Tregs) at 12 weeks (after the intervention and another 6 weeks of wash out)	Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. The assessment of Trges after 12 weeks aims to identify any persisting effects of the intervention.	Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Secondary	Change of baseline gut microbiome at 6 weeks (after the intervention)	Stool samples will be collected with the PSP spin stool DNA stool collection kit (Stratec, Birkenfeld, GER) and processed according to the suppliers recommendations. Subsequently to DNA extraction the variable V1-V2 region of the bacterial 16S rRNA gene is amplified with PCR using oligonucleotide primers BSF8 and BSR357.	Determination at baseline (day 0) and after 6 weeks (after the intervention)
Secondary	Change of baseline gut microbiome at 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)	Stool samples will be collected with the PSP spin stool DNA stool collection kit (Stratec, Birkenfeld, GER) and processed according to the suppliers recommendations. Subsequently to DNA extraction the variable V1-V2 region of the bacterial 16S rRNA gene is amplified with PCR using oligonucleotide primers BSF8 and BSR357. The assessment of the change in the gut microbiome after 12 weeks aims to identify any persisting effects of the intervention.	Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)