The Link Between Diets and Health Indicators

Microbiota Clinical Trial

— DIETE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347213
• Other study ID #: DIETE
• Status: Completed
• Start date: January 18, 2020
• Est. completion date: January 15, 2023

Study information

• Verified date: August 2023
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Diet
• Microbiota

Intervention

Behavioral:
• Regular lifestyle in different circumstances
Participants' lifestyle will be followed over the years.

Locations

Country	Name	City	State
Slovenia	University of Primorska, Faculty of Health Sciences	Izola

Sponsors (1)

Lead Sponsor	Collaborator
University of Primorska

Country where clinical trial is conducted

Slovenia, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in systemic inflammation	CRP [mg/L] will be measured as a marker of inflammation.	Change from baseline at 5 years.
Primary	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	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.	Change from baseline at 5 years.
Secondary	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.	Change from baseline at 5 years.
Secondary	Changes in gut microbiota composition	Microbial composition of stool will be determined with microbial DNA isolation and identification.	Change from baseline at 5 years.
Secondary	Changes in body composition	Fat free body mass will be measured with bioelectrical impedance analysis and expressed in kg.	Change from baseline at 5 years.
Secondary	Changes in resting metabolic rate	Resting metabolic rate will be determined with indirect calorimeter and expressed in kJ/day.	Change from baseline at 5 years.
Secondary	Changes in lifestyle factors	Will be assessed with a questionnaire.	Change from baseline at 5 years.
Secondary	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.	Change from baseline at 5 years.
Secondary	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).	Change from baseline at 5 years.
Secondary	Changes in grip strength	Will be measured with a hand dynamometer.	Change from baseline at 5 years.
Secondary	Changes in autophagy	Autophagy will be measured by autophagy-related mRNA gene expression evaluation.	Change from baseline at 5 years.