Clinical trial NCT04347213: The Link Between Diets and Health Indicators
Official title: The Link Between Omnivorous, Vegan, Vegetarian, Low Carb Diets and Health Indicators in Healthy Subjects With Normal Weight
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Diet
Microbiota
Keywords: diet
gut microbiota
longevity
inflammation
health
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals with stable body mass with specific eating patterns: omnivores, vegetarians, vegan, low carb high fat.

Brief 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, lifestyle factors and psychological factors will be determined and measured.

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.

Eligibility 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

Primary outcomes:
measure: Changes in systemic inflammation
timeFrame: Change from baseline at 5 years.
measure: Changes in serum total antioxidative capacity
timeFrame: Change from baseline at 5 years.
Secondary outcomes:
measure: Changes in macronutrient intake
timeFrame: Change from baseline at 5 years.
measure: Changes in micronutrient intake
timeFrame: Change from baseline at 5 years.
measure: Changes in gut microbiota composition
timeFrame: Change from baseline at 5 years.
measure: Changes in body composition
timeFrame: Change from baseline at 5 years.
measure: Changes in resting metabolic rate
timeFrame: Change from baseline at 5 years.
measure: Changes in lifestyle factors
timeFrame: Change from baseline at 5 years.
measure: Changes in anxiety
timeFrame: Change from baseline at 5 years.
measure: Changes in body satisfaction
timeFrame: Change from baseline at 5 years.
measure: Changes in grip strength
timeFrame: Change from baseline at 5 years.
measure: Changes in autophagy
timeFrame: Change from baseline at 5 years.
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
affiliation: University of Primorska, Faculty of Health Sciences
name: Zala Jenko Pražnikar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Primorska, Faculty of Health Sciences
name: Nina Mohorko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.