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

February 28, 2023 updated by: Zala Jenko Praznikar, University of Primorska

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Izola, Slovenia, SI-6310
        • University of Primorska Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asymptomatic adults

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Primorska

Collaborators

Elettra Synchrotron Trieste

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Actual)

August 20, 2022

Study Completion (Actual)

November 20, 2022

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIETE-FTIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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