Asymptomatic ConditionFTIRNCT05377164
Long Term Effects of Different Dietary Protocols on Determinants of Health in Patients' Lymphocytes
An observational study of Asymptomatic Condition, run by University of Primorska at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Asymptomatic Condition
- What is being tested?
- food choices
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 May 2022to 20 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Adult
Study population: Asymptomatic adults
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska Faculty of Health Sciences
Izola, SI-6310
About this study
Official title: 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.
Read the 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.
- Conditions
- Asymptomatic Condition
- Being tested
- food choices
- Keywords
- diet, lipid peroxidation, DNA damage
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food choicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Vegetarian group | Not described Receives: Behavioral: food choices | |
| Omnivorous group | Not described Receives: Behavioral: food choices | |
| Low carbohydrate group | Not described Receives: Behavioral: food choices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start20 May 2022
- Primary completion20 Aug 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- Elettra Synchrotron Trieste
- Responsible party
- Principal investigator, Zala Jenko Praznikar, University of Primorska
- Investigators
- Saša Kenig, PhD, Principal investigator, University of Primorska Faculty of Health Sciences, Polje 42 SI-6310 Izola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377164
- Sponsor's protocol ID
- DIETE-FTIR
- Acronym
- FTIR
- Status last verified
- Feb 2023
- First submitted
- 6 May 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23651522Barraza-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.
PubMed 27213031Gioacchini 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.
PubMed 24140036Kenig 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.
PubMed 31445313Mohorko 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.
PubMed 30803508Rizza 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.
PubMed 24291541Wilkosz N, Czaja M, Seweryn S, Skirlinska-Nosek K, Szymonski M, Lipiec E, Sofinska K. Molecular Spectroscopic Markers of Abnormal Protein Aggregation. Molecules. 2020 May 27;25(11):2498. doi: 10.3390/molecules25112498.
PubMed 32471300Vargas-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.
PubMed 24667417
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Different Dietary Protocols on Determinants of Health in Patients' Lymphocytes Analysed by FTIR
- ClinicalTrials.gov ID
- NCT05377164
- Acronym / sponsor ID
- FTIR / DIETE-FTIR
- Conditions
- Asymptomatic Condition
- Keywords
- diet, lipid peroxidation, DNA damage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- Elettra Synchrotron Trieste
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegetarian group | – | Behavioral: food choices |
| Omnivorous group | – | Behavioral: food choices |
| Low carbohydrate group | – | Behavioral: food choices |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Asymptomatic adults
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food choicesAnalysis 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. | Behavioural | Low carbohydrate group, Omnivorous group, Vegetarian group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 23651522Bueno 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.
- Background: PubMed 27213031Barraza-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.
- Background: PubMed 24140036Gioacchini 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.
- Background: PubMed 31445313Kenig 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.
- Background: PubMed 30803508Mohorko 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.
- Background: PubMed 24291541Rizza 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.
- Background: PubMed 32471300Wilkosz N, Czaja M, Seweryn S, Skirlinska-Nosek K, Szymonski M, Lipiec E, Sofinska K. Molecular Spectroscopic Markers of Abnormal Protein Aggregation. Molecules. 2020 May 27;25(11):2498. doi: 10.3390/molecules25112498.
- Background: PubMed 24667417Vargas-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.
- Individual participant dataSharing planned: Undecided
Related trials for Asymptomatic Condition
RecruitingPhase 3
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Recruiting
Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers
Spinal Muscular Atrophy (SMA), Charcot-Marie-Tooth
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saša Kenig, PhD principal investigator
University of Primorska Faculty of Health Sciences, Polje 42 SI-6310 Izola
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asymptomatic Condition, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fourier transform infrared spectra of absorbance at wavelenghts from 500 to 5000 cm-1 (time frame: through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05377164, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.