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Trial record 3 of 21 for:    sasa

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

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ClinicalTrials.gov Identifier: NCT05377164
Recruitment Status : Recruiting
First Posted : May 17, 2022
Last Update Posted : May 17, 2022
Sponsor:
Collaborator:
Elettra Synchrotron Trieste
Information provided by (Responsible Party):
Zala Jenko Praznikar, University of Primorska

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.

Condition or disease Intervention/treatment
Asymptomatic Condition Behavioral: food choices

Detailed Description:

Scientific Background: In the overall population there is an increasing awareness that with a healthy lifestyle many chronic non-communicable diseases can be prevented or delayed in their progression. Among them diabetes type II, metabolic syndrome, hypertension and atherosclerosis are recognized as major public health issues also causing the highest proportion of deaths in the modern world. Food choices and eating habits in general play an important role in management of these diseases. There are, however, many popular diets for which there is yet no consensus on their actual possibility to exert health effects. Dietary protocols where whole food groups are excluded are especially known to have some beneficial but also some harmful effects, in particular when not planned properly and used for long periods. Two extremely different lifestyle choices are particularly common in recent years, namely low carbohydrate/high fat (LCHF) diet and vegetarian diet. In the first one, also called ketogenic diet, one eliminates all carbohydrate rich foods, such as fruit, legumes and cereals, but consumes a lot of fats, even up to 90 % of daily energy intake. Such diet is very efficient as a weight-loss program (Mohorko et al., 2019) and when used for shorter periods, was shown to have no adverse effects on total cholesterol or LDL levels. It was also efficient in decreasing the levels of serum glucose and triglycerides (Bueno et al., 2013), but in some cases was calcium deficient (Kenig et al., 2019). Long term effects have not been well investigated and a concern that high fat intake may cause more oxidative stress due to increased beta oxidation remains. Vegan diet, on the other hand, also eliminates a whole food group (meat and dairy products), which may cause depletion of some micronutrients, such as iron and vitamin B12. But, such diet is rich in antioxidants, decreases cholesterol levels and seems to increase longevity (Rizza et al., 2014). Again, studies investigating long-term effects are few.

Motivation for the proposal: In recent years, it has been shown that FTIR can identify many cellular characteristics that are related to the overall "health" of a cell. In the lymphocytes of rats under stress, increased lipid peroxidation was detected by FTIR (Vargas-Caraveo et al., 2014). In human oocytes spectral bands related to lipid saturation, membrane permeability, protein degradation and altered lipid synthesis were found to be changed with aging (Gioacchini et al., 2014). When investigating effects of diets, it is reasonable to expect that lipid content in the cells may change, there may also be differences in the extent of lipid peroxidation or other consequences of oxidative stress. DNA damage, for example, such as single and double strand breaks or DNA-protein cross links, could be induced or inhibited by different dietary ingredients and also identified with FTIR (Sofińska et al., 2020). All these parameters are very important, since increased lipid peroxidation is one of the factors contributing to the development of atherosclerosis, whereas lymphocyte membrane permeabilization and DNA damage are related to cell death and consequential impairment of the immune system. There are studies showing relevant contribution of different diets to these diseases, but underlying molecular mechanisms are not entirely clear. FTIR analysis could then provide interesting novel information, which is the objective of this proposal. In contrast to several biochemical parameters (i.e. cholesterol levels) that somewhat fluctuate depending on recently consumed foods, FTIR analysis of lymphocytes might give information on long-term consequences of a particular lifestyle.

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Long Term Effects of Different Dietary Protocols on Determinants of Health in Patients' Lymphocytes Analysed by FTIR
Estimated Study Start Date : May 20, 2022
Estimated Primary Completion Date : August 20, 2022
Estimated Study Completion Date : October 20, 2022

Group/Cohort Intervention/treatment
Vegetarian group Behavioral: food choices
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.

Omnivorous group Behavioral: food choices
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 Behavioral: food choices
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.




Primary Outcome Measures :
  1. Fourier transform infrared spectra of absorbance at wavelenghts from 500 to 5000 cm-1 [ Time Frame: through study completion, an average of 4 months ]
    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.


Biospecimen Retention:   None Retained
Serum samples


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Asymptomatic adults
Criteria

Inclusion Criteria:

  • 18,5 < 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05377164


Contacts
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Contact: Saša Kenig, PhD 0038656635801 sasa.kenig@fvz.upr.si
Contact: Nina Mohorko, PhD 0038656635801 nina.mohorko@fvz.upr.si

Locations
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Slovenia
University of Primorska Faculty of Health Sciences Recruiting
Izola, Slovenia, SI-6310
Contact: Zala Jenko Pražnikar, PhD    0038656626469    zala.praznikar@upr.si   
Contact: Saša Kenig, PhD    0038656635801    sasa.kenig@fvz.upr.si   
Sponsors and Collaborators
University of Primorska
Elettra Synchrotron Trieste
Investigators
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Principal Investigator: Saša Kenig, PhD University of Primorska Faculty of Health Sciences, Polje 42 SI-6310 Izola
Publications:

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Responsible Party: Zala Jenko Praznikar, assoc. prof., University of Primorska
ClinicalTrials.gov Identifier: NCT05377164    
Other Study ID Numbers: DIETE-FTIR
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zala Jenko Praznikar, University of Primorska:
diet
lipid peroxidation
DNA damage
Additional relevant MeSH terms:
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Asymptomatic Diseases
Disease Attributes
Pathologic Processes