Long Term Effects of Different Dietary Protocols on Determinants of Health in Patients' Lymphocytes

NCT05377164 | Completed

• 1 other identifier: DIETE-FTIR
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Food choices and eating habits play an important role in the management of common noncommunicable diseases, i.e. diabetes type II, hypertension, metabolic syndrome and others. However, for many popular diets there is yet no consensus on their actual ability to exert health effects and, regardless of some promising results, the underlying molecular mechanisms are not entirely clear. FTIR analysis could provide interesting new information; we therefore propose the analysis of lymphocytes isolated from the peripheral blood of participants who had been on vegan, ketogenic or normal mixed diet for at least one year. In particular we plan to monitor differences in lipid peroxidation, membrane permeability, protein synthesis and DNA damage. All these parameters are important in the development of the above mentioned diseases and were previously shown to be detectable by FTIR. The results will contribute importantly to the understanding of the long-term effects of the respective lifestyle and will allow the formulation of better dietary recommendations to the public.

Conditions

Asymptomatic Condition

Keywords

diet; lipid peroxidation; DNA damage

Outcome Measures

Primary Outcomes (1)

• Fourier transform infrared spectra of absorbance at wavelenghts from 500 to 5000 cm-1

  Different chemical bonds absorb light at different wavelenghts. This gives information on lipid, protein, DNA, carbohydrate composition of a cell. For individual cells, 256 scans per spectrum will be averaged at 4 cm-1 spectral resolution in transmission mode (15X condenser/objective), 100 cells per sample will be measured.

  through study completion, an average of 4 months

Study Arms (3)

Vegetarian group

Behavioral: food choices

Omnivorous group

Behavioral: food choices

Low carbohydrate group

Behavioral: food choices

Interventions

food choices BEHAVIORAL

Analysis of lymphocytes isolated from the peripheral blood of participants who had been on vegetarian, ketogenic or normal mixed diet for at least one year will be performed.

Low carbohydrate group; Omnivorous group; Vegetarian group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Asymptomatic adults

You may qualify if:

• ,5 \< BMI \< 30 kg/m2
• asymptomatic for any disease
• medication free
• same pattern of eating in the last 3 months
• stable body mass in the last 3 months

You may not qualify if:

• BMI \< 18,5 and \> 30 kg/m2
• presence of any chronic disease
• taking any medications
• changed eating pattern in the last 3 months
• unstable body mass in the last 3 months
• taking antibiotics in the last 3 months

Sponsors & Collaborators

• University of Primorska: lead
• Elettra Synchrotron Trieste: collaborator

Study Sites (1)

University of Primorska Faculty of Health Sciences

Izola, SI-6310, Slovenia

Location

Related Publications (8)

• Bueno NB, de Melo IS, de Oliveira SL, da Rocha Ataide T. Very-low-carbohydrate ketogenic diet v. low-fat diet for long-term weight loss: a meta-analysis of randomised controlled trials. Br J Nutr. 2013 Oct;110(7):1178-87. doi: 10.1017/S0007114513000548. Epub 2013 May 7.

  PMID: 23651522 BACKGROUND

• Barraza-Garza G, Castillo-Michel H, de la Rosa LA, Martinez-Martinez A, Perez-Leon JA, Cotte M, Alvarez-Parrilla E. Infrared Spectroscopy as a Tool to Study the Antioxidant Activity of Polyphenolic Compounds in Isolated Rat Enterocytes. Oxid Med Cell Longev. 2016;2016:9245150. doi: 10.1155/2016/9245150. Epub 2016 Apr 26.

  PMID: 27213031 BACKGROUND

• Gioacchini G, Giorgini E, Vaccari L, Ferraris P, Sabbatini S, Bianchi V, Borini A, Carnevali O. A new approach to evaluate aging effects on human oocytes: Fourier transform infrared imaging spectroscopy study. Fertil Steril. 2014 Jan;101(1):120-7. doi: 10.1016/j.fertnstert.2013.09.012. Epub 2013 Oct 17.

  PMID: 24140036 BACKGROUND

• Kenig S, Petelin A, Poklar Vatovec T, Mohorko N, Jenko-Praznikar Z. Assessment of micronutrients in a 12-wk ketogenic diet in obese adults. Nutrition. 2019 Nov-Dec;67-68:110522. doi: 10.1016/j.nut.2019.06.003. Epub 2019 Jun 14.

  PMID: 31445313 BACKGROUND

• Mohorko N, Cernelic-Bizjak M, Poklar-Vatovec T, Grom G, Kenig S, Petelin A, Jenko-Praznikar Z. Weight loss, improved physical performance, cognitive function, eating behavior, and metabolic profile in a 12-week ketogenic diet in obese adults. Nutr Res. 2019 Feb;62:64-77. doi: 10.1016/j.nutres.2018.11.007. Epub 2018 Nov 12.

  PMID: 30803508 BACKGROUND

• Rizza W, Veronese N, Fontana L. What are the roles of calorie restriction and diet quality in promoting healthy longevity? Ageing Res Rev. 2014 Jan;13:38-45. doi: 10.1016/j.arr.2013.11.002. Epub 2013 Nov 27.

  PMID: 24291541 BACKGROUND

• Sofinska K, Wilkosz N, Szymonski M, Lipiec E. Molecular Spectroscopic Markers of DNA Damage. Molecules. 2020 Jan 28;25(3):561. doi: 10.3390/molecules25030561.

  PMID: 32012927 BACKGROUND

• Vargas-Caraveo A, Castillo-Michel H, Mejia-Carmona GE, Perez-Ishiwara DG, Cotte M, Martinez-Martinez A. Preliminary studies of the effects of psychological stress on circulating lymphocytes analyzed by synchrotron radiation based-Fourier transform infrared microspectroscopy. Spectrochim Acta A Mol Biomol Spectrosc. 2014 Jul 15;128:141-6. doi: 10.1016/j.saa.2014.02.148. Epub 2014 Mar 12.

  PMID: 24667417 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Serum samples

MeSH Terms

Conditions

Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saša Kenig, PhD

  University of Primorska Faculty of Health Sciences, Polje 42 SI-6310 Izola

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 17, 2022
• Study Start: May 20, 2022
• Primary Completion: August 20, 2022
• Study Completion: November 20, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

SL (1)