Healthy DietDIETENCT04347213

The Link Between Diets and Health Indicators

An observational study of Healthy Diet and Microbiota, run by University of Primorska at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The cohort study investigates the effect of different dietary intake among omnivorous, vegan, vegetarian and low-carb diets on health parameters and on long-term overall health. The participants blood parameters, dietary intake, gut microbiota composition, body mass and composition, resting energy expenditure… Read more about this study

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Diet, Microbiota
What is being tested?: Regular lifestyle in different circumstances
Type of treatment: Lifestyle or therapy programme
How many people: 200 participants
Where: 1 siteSlovenia
Study dates: 18 Jan 2020to 15 Jan 2023
How long will I take part?: 10 Years
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
Healthy volunteers accepted
Adult

Study population: Healthy individuals with stable body mass with specific eating patterns: omnivores, vegetarians, vegan, low carb high fat.

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

Other trials in Slovenia

About this study

Official title: The Link Between Omnivorous, Vegan, Vegetarian, Low Carb Diets and Health Indicators in Healthy Subjects With Normal Weight

Read the detailed description

Vegetarian and vegan diets have been shown to have health benefits on preventing cardiovascular diseases, type 2 diabetes and cancer. They are both gaining popularity in public. Ketogenic diet has also been very popular, especially due to its effect on weight loss and blood glucose parameters. To our knowledge there, are no studies that compare long-term effects of all three diets and omnivorous diets with regards to health parameters and gut microbiota composition.

The aim of the proposed study is to investigate the link between different diets and health parameters, such as parameters related to longevity, inflammation, stress and gut microbiota composition. The study is designed to compare different diets and their relationship with the body as a whole.

Conditions: Healthy Diet, Microbiota
Being tested: Regular lifestyle in different circumstances
Keywords: diet, gut microbiota, longevity, inflammation, health
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Regular lifestyle in different circumstancesBehavioural
Participants' lifestyle will be followed over the years.

Study groups in NCT04347213
Study group	Role	What they receive
omnivors		Participants who habitually consume all food groups in their diet. Receives: Behavioral: Regular lifestyle in different circumstances
vegetarian		Participants who habitually avoid meat in their diet. Receives: Behavioral: Regular lifestyle in different circumstances
vegan		Participants who habitually avoid all animal source food in their diet. Receives: Behavioral: Regular lifestyle in different circumstances
low-carbohydrate high-fat diet		Participants who habitually avoid carbohydrate in their diet. Receives: Behavioral: Regular lifestyle in different circumstances

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in systemic inflammation
CRP [mg/L] will be measured as a marker of inflammation.
Measured: Change from baseline at 5 years.
Changes in serum total antioxidative capacity
Total antioxidative capacity of serum will be measured with Photochem instrument and expressed as nanomole equivalents of ascorbic acid per microliter of serum.
Measured: Change from baseline at 5 years.

Secondary outcomes (10)

Changes in macronutrient intake
Macronutrient intake will be measured with validated FFQ and 3-day food diary and analysed with softwares OPEN and Prodi. Macronutrient intake will be expressed as part of daily energy intake.
Measured: Change from baseline at 5 years.
Changes in micronutrient intake
Micronutrient intake will be measured with validated FFQ and 3-day food diary and analysed with softwares OPEN and Prodi. Micronutrient intake will be expressed as mg per day.
Measured: Change from baseline at 5 years.
Changes in gut microbiota composition
Microbial composition of stool will be determined with microbial DNA isolation and identification.
Measured: Change from baseline at 5 years.
Changes in body composition
Fat free body mass will be measured with bioelectrical impedance analysis and expressed in kg.
Measured: Change from baseline at 5 years.
Changes in resting metabolic rate
Resting metabolic rate will be determined with indirect calorimeter and expressed in kJ/day.
Measured: Change from baseline at 5 years.
Changes in lifestyle factors
Will be assessed with a questionnaire.
Measured: Change from baseline at 5 years.
Changes in anxiety
Will be assessed by state-trait anxiety inventory. The STAIX-1 contains 20 items, which are scored on a 4-pointscale with subscale scores ranging from 20 to 80, with higherscores indicating higher anxiety.
Measured: Change from baseline at 5 years.
Changes in body satisfaction
Will be assessed by the body dissatisfaction subscale from the Eating Disorders Inventory-2. Responses will be rated on a 5-point Likert scale from 0 (never) to 4 (always).
Measured: Change from baseline at 5 years.
Changes in grip strength
Will be measured with a hand dynamometer.
Measured: Change from baseline at 5 years.
Changes in autophagy
Autophagy will be measured by autophagy-related mRNA gene expression evaluation.
Measured: Change from baseline at 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 202015 Jan 2023

First posted15 Apr 2020
Study start18 Jan 2020
Primary completion15 Jan 2022
Study completion15 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Healthy DietStudies 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: Cohort
Time perspective: Prospective
Enrolment: 200 participants (actual)
Target duration: 10 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT04347213
Sponsor's protocol ID: DIETE
Acronym: DIETE
Status last verified: Aug 2023
First submitted: 3 Apr 2020
Last updated: 8 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Paoli A, Mancin L, Bianco A, Thomas E, Mota JF, Piccini F. Ketogenic Diet and Microbiota: Friends or Enemies? Genes (Basel). 2019 Jul 15;10(7):534. doi: 10.3390/genes10070534.
PubMed 31311141
Rocha JP, Laster J, Parag B, Shah NU. Multiple Health Benefits and Minimal Risks Associated with Vegetarian Diets. Curr Nutr Rep. 2019 Dec;8(4):374-381. doi: 10.1007/s13668-019-00298-w.
PubMed 31705483
Sakkas H, Bozidis P, Touzios C, Kolios D, Athanasiou G, Athanasopoulou E, Gerou I, Gartzonika C. Nutritional Status and the Influence of the Vegan Diet on the Gut Microbiota and Human Health. Medicina (Kaunas). 2020 Feb 22;56(2):88. doi: 10.3390/medicina56020088.
PubMed 32098430
Satija A, Bhupathiraju SN, Rimm EB, Spiegelman D, Chiuve SE, Borgi L, Willett WC, Manson JE, Sun Q, Hu FB. Plant-Based Dietary Patterns and Incidence of Type 2 Diabetes in US Men and Women: Results from Three Prospective Cohort Studies. PLoS Med. 2016 Jun 14;13(6):e1002039. doi: 10.1371/journal.pmed.1002039. eCollection 2016 Jun.
PubMed 27299701
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.
PubMed 31445313
Mohorko N, Petelin A, Jurdana M, Biolo G, Jenko-Praznikar Z. Elevated serum levels of cysteine and tyrosine: early biomarkers in asymptomatic adults at increased risk of developing metabolic syndrome. Biomed Res Int. 2015;2015:418681. doi: 10.1155/2015/418681. Epub 2015 Mar 4.
PubMed 25821801
Mohorko N, Jenko-Praznika Z, Petelin A. Leucine and lysine intakes are highly associated with serum adiponectin levels in asymptomatic adults. Minerva Endocrinol. 2016 Sep;41(3):302-13. Epub 2015 Feb 13.
PubMed 25677829
Cernelic-Bizjak M, Jenko-Praznikar Z. Body dissatisfaction predicts inflammatory status in asymptomatic healthy individuals. J Health Psychol. 2018 Jan;23(1):25-35. doi: 10.1177/1359105316672923. Epub 2016 Oct 19.
PubMed 28810361
Bizjak M, Jenko-Praznikar Z, Korousic Seljak B. Development and validation of an electronic FFQ to assess food intake in the Slovene population. Public Health Nutr. 2014 Aug;17(8):1729-37. doi: 10.1017/S1368980013002577. Epub 2013 Oct 8.
PubMed 24103359
Jenko-Praznikar Z, Petelin A, Jurdana M, Ziberna L. Serum bilirubin levels are lower in overweight asymptomatic middle-aged adults: an early indicator of metabolic syndrome? Metabolism. 2013 Jul;62(7):976-85. doi: 10.1016/j.metabol.2013.01.011. Epub 2013 Feb 13.
PubMed 23414908
Bogataj Jontez N, Kenig S, Sik Novak K, Petelin A, Jenko Praznikar Z, Mohorko N. Habitual low carbohydrate high fat diet compared with omnivorous, vegan, and vegetarian diets. Front Nutr. 2023 Apr 13;10:1106153. doi: 10.3389/fnut.2023.1106153. eCollection 2023.
PubMed 37125046
Sik Novak K, Bogataj Jontez N, Kenig S, Hladnik M, Baruca Arbeiter A, Bandelj D, Cernelic Bizjak M, Petelin A, Mohorko N, Jenko Praznikar Z. The effect of COVID-19 lockdown on mental health, gut microbiota composition and serum cortisol levels. Stress. 2022 Jan;25(1):246-257. doi: 10.1080/10253890.2022.2082280.
PubMed 35713539

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Diet trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Link Between Omnivorous, Vegan, Vegetarian, Low Carb Diets and Health Indicators in Healthy Subjects With Normal Weight
ClinicalTrials.gov ID: NCT04347213
Acronym / sponsor ID: DIETE / DIETE
Conditions: Healthy Diet, Microbiota
Keywords: diet, gut microbiota, longevity, inflammation, health
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: University of PrimorskaUniversity, hospital or other
Study start: 18 Jan 2020 (actual)
Primary completion: 15 Jan 2022 (actual)
Study completion: 15 Jan 2023 (actual)
First posted: 15 Apr 2020 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 10 Years
Number of arms: 4

Arm	Type	Receives
omnivors	–	Behavioral: Regular lifestyle in different circumstancesParticipants who habitually consume all food groups in their diet.
vegetarian	–	Behavioral: Regular lifestyle in different circumstancesParticipants who habitually avoid meat in their diet.
vegan	–	Behavioral: Regular lifestyle in different circumstancesParticipants who habitually avoid all animal source food in their diet.
low-carbohydrate high-fat diet	–	Behavioral: Regular lifestyle in different circumstancesParticipants who habitually avoid carbohydrate in their diet.

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: Healthy individuals with stable body mass with specific eating patterns: omnivores, vegetarians, vegan, low carb high fat.

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
Regular lifestyle in different circumstancesParticipants' lifestyle will be followed over the years.	Behavioural	low-carbohydrate high-fat diet, omnivors, vegan, vegetarian

Primary outcome

Changes in systemic inflammation
Time frame: Change from baseline at 5 years.
CRP [mg/L] will be measured as a marker of inflammation.
Changes in serum total antioxidative capacity
Time frame: Change from baseline at 5 years.
Total antioxidative capacity of serum will be measured with Photochem instrument and expressed as nanomole equivalents of ascorbic acid per microliter of serum.

10 secondary outcomes

Changes in macronutrient intake
Time frame: Change from baseline at 5 years.
Changes in micronutrient intake
Time frame: Change from baseline at 5 years.
Changes in gut microbiota composition
Time frame: Change from baseline at 5 years.
Changes in body composition
Time frame: Change from baseline at 5 years.
Changes in resting metabolic rate
Time frame: Change from baseline at 5 years.
Changes in lifestyle factors
Time frame: Change from baseline at 5 years.
Changes in anxiety
Time frame: Change from baseline at 5 years.
Changes in body satisfaction
Time frame: Change from baseline at 5 years.
Changes in grip strength
Time frame: Change from baseline at 5 years.
Changes in autophagy
Time frame: Change from baseline at 5 years.

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 8 Aug 2023.
Background: PubMed 31311141Paoli A, Mancin L, Bianco A, Thomas E, Mota JF, Piccini F. Ketogenic Diet and Microbiota: Friends or Enemies? Genes (Basel). 2019 Jul 15;10(7):534. doi: 10.3390/genes10070534.
Background: PubMed 31705483Rocha JP, Laster J, Parag B, Shah NU. Multiple Health Benefits and Minimal Risks Associated with Vegetarian Diets. Curr Nutr Rep. 2019 Dec;8(4):374-381. doi: 10.1007/s13668-019-00298-w.
Background: PubMed 32098430Sakkas H, Bozidis P, Touzios C, Kolios D, Athanasiou G, Athanasopoulou E, Gerou I, Gartzonika C. Nutritional Status and the Influence of the Vegan Diet on the Gut Microbiota and Human Health. Medicina (Kaunas). 2020 Feb 22;56(2):88. doi: 10.3390/medicina56020088.
Background: PubMed 27299701Satija A, Bhupathiraju SN, Rimm EB, Spiegelman D, Chiuve SE, Borgi L, Willett WC, Manson JE, Sun Q, Hu FB. Plant-Based Dietary Patterns and Incidence of Type 2 Diabetes in US Men and Women: Results from Three Prospective Cohort Studies. PLoS Med. 2016 Jun 14;13(6):e1002039. doi: 10.1371/journal.pmed.1002039. eCollection 2016 Jun.
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 25821801Mohorko N, Petelin A, Jurdana M, Biolo G, Jenko-Praznikar Z. Elevated serum levels of cysteine and tyrosine: early biomarkers in asymptomatic adults at increased risk of developing metabolic syndrome. Biomed Res Int. 2015;2015:418681. doi: 10.1155/2015/418681. Epub 2015 Mar 4.
Background: PubMed 25677829Mohorko N, Jenko-Praznika Z, Petelin A. Leucine and lysine intakes are highly associated with serum adiponectin levels in asymptomatic adults. Minerva Endocrinol. 2016 Sep;41(3):302-13. Epub 2015 Feb 13.
Background: PubMed 28810361Cernelic-Bizjak M, Jenko-Praznikar Z. Body dissatisfaction predicts inflammatory status in asymptomatic healthy individuals. J Health Psychol. 2018 Jan;23(1):25-35. doi: 10.1177/1359105316672923. Epub 2016 Oct 19.
Background: PubMed 24103359Bizjak M, Jenko-Praznikar Z, Korousic Seljak B. Development and validation of an electronic FFQ to assess food intake in the Slovene population. Public Health Nutr. 2014 Aug;17(8):1729-37. doi: 10.1017/S1368980013002577. Epub 2013 Oct 8.
Background: PubMed 23414908Jenko-Praznikar Z, Petelin A, Jurdana M, Ziberna L. Serum bilirubin levels are lower in overweight asymptomatic middle-aged adults: an early indicator of metabolic syndrome? Metabolism. 2013 Jul;62(7):976-85. doi: 10.1016/j.metabol.2013.01.011. Epub 2013 Feb 13.
Derived from this study: PubMed 37125046Bogataj Jontez N, Kenig S, Sik Novak K, Petelin A, Jenko Praznikar Z, Mohorko N. Habitual low carbohydrate high fat diet compared with omnivorous, vegan, and vegetarian diets. Front Nutr. 2023 Apr 13;10:1106153. doi: 10.3389/fnut.2023.1106153. eCollection 2023.
Derived from this study: PubMed 35713539Sik Novak K, Bogataj Jontez N, Kenig S, Hladnik M, Baruca Arbeiter A, Bandelj D, Cernelic Bizjak M, Petelin A, Mohorko N, Jenko Praznikar Z. The effect of COVID-19 lockdown on mental health, gut microbiota composition and serum cortisol levels. Stress. 2022 Jan;25(1):246-257. doi: 10.1080/10253890.2022.2082280.
Individual participant dataSharing planned: Undecided

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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.

Zala Jenko Pražnikar, PhD principal investigator

University of Primorska, Faculty of Health Sciences

Nina Mohorko, PhD principal investigator

University of Primorska, Faculty of Health Sciences

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 Healthy Diet and Microbiota, 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 8 Aug 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?

Changes in systemic inflammation (time frame: Change from baseline at 5 years.). The study lists 2 primary outcomes in all. 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 NCT04347213, which also lists 12 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 8 Aug 2023.