The Link Between Diets and Health Indicators

NCT04347213 | Completed

• 1 other identifier: DIETE
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Diet; Microbiota

Keywords

diet; gut microbiota; longevity; inflammation; health

Outcome Measures

Primary Outcomes (2)

• Changes in systemic inflammation

  CRP \[mg/L\] will be measured as a marker of inflammation.

  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.

  Change from baseline at 5 years.

Secondary Outcomes (10)

• Changes in macronutrient intake

  Change from baseline at 5 years.

• Changes in micronutrient intake

  Change from baseline at 5 years.

• Changes in gut microbiota composition

  Change from baseline at 5 years.

• Changes in body composition

  Change from baseline at 5 years.

• Changes in resting metabolic rate

  Change from baseline at 5 years.

Study Arms (4)

omnivors

Participants who habitually consume all food groups in their diet.

Behavioral: Regular lifestyle in different circumstances

vegetarian

Participants who habitually avoid meat in their diet.

Behavioral: Regular lifestyle in different circumstances

vegan

Participants who habitually avoid all animal source food in their diet.

Behavioral: Regular lifestyle in different circumstances

low-carbohydrate high-fat diet

Participants who habitually avoid carbohydrate in their diet.

Behavioral: Regular lifestyle in different circumstances

Interventions

Regular lifestyle in different circumstances BEHAVIORAL

Participants' lifestyle will be followed over the years.

low-carbohydrate high-fat diet; omnivors; vegan; vegetarian

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ,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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Primorska: lead

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, SI-6310, Slovenia

Location

Related Publications (12)

• 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.

  PMID: 31311141 BACKGROUND

• 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.

  PMID: 31705483 BACKGROUND

• 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.

  PMID: 32098430 BACKGROUND

• 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.

  PMID: 27299701 BACKGROUND

• 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.

  PMID: 31445313 BACKGROUND

• 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.

  PMID: 25821801 BACKGROUND

• 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.

  PMID: 25677829 BACKGROUND

• 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.

  PMID: 28810361 BACKGROUND

• 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.

  PMID: 24103359 BACKGROUND

• 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.

  PMID: 23414908 BACKGROUND

• 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.

  PMID: 37125046 DERIVED

• 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.

  PMID: 35713539 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and stool samples

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zala Jenko Pražnikar, PhD

  University of Primorska, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

• Nina Mohorko, PhD

  University of Primorska, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 15, 2020
• Study Start: January 18, 2020
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

SL (1)