DIETE: The Link Between Diets and Health Indicators

Sponsor

University of Primorska (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04347213

Collaborator

(none)

200

Enrollment

Location

143.9

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Diet Microbiota	Behavioral: Regular lifestyle in different circumstances

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 18, 2020

Actual Primary Completion Date :

Jan 15, 2022

Anticipated Study Completion Date :

Jan 15, 2032

Arms and Interventions

Arm	Intervention/Treatment
omnivors Participants who habitually consume all food groups in their diet.	Behavioral: Regular lifestyle in different circumstances Participants' lifestyle will be followed over the years.
vegetarian Participants who habitually avoid meat in their diet.	Behavioral: Regular lifestyle in different circumstances Participants' lifestyle will be followed over the years.
vegan Participants who habitually avoid all animal source food in their diet.	Behavioral: Regular lifestyle in different circumstances Participants' lifestyle will be followed over the years.
low-carbohydrate high-fat diet Participants who habitually avoid carbohydrate in their diet.	Behavioral: Regular lifestyle in different circumstances Participants' lifestyle will be followed over the years.

Outcome Measures

Primary Outcome Measures

Changes in systemic inflammation [Change from baseline at 5 years.]
CRP [mg/L] will be measured as a marker of inflammation.
Changes in serum total antioxidative capacity [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.

Secondary Outcome Measures

Changes in macronutrient intake [Change from baseline at 5 years.]
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.
Changes in micronutrient intake [Change from baseline at 5 years.]
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.
Changes in gut microbiota composition [Change from baseline at 5 years.]
Microbial composition of stool will be determined with microbial DNA isolation and identification.
Changes in body composition [Change from baseline at 5 years.]
Fat free body mass will be measured with bioelectrical impedance analysis and expressed in kg.
Changes in resting metabolic rate [Change from baseline at 5 years.]
Resting metabolic rate will be determined with indirect calorimeter and expressed in kJ/day.
Changes in lifestyle factors [Change from baseline at 5 years.]
Will be assessed with a questionnaire.
Changes in anxiety [Change from baseline at 5 years.]
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.
Changes in body satisfaction [Change from baseline at 5 years.]
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).
Changes in grip strength [Change from baseline at 5 years.]
Will be measured with a hand dynamometer.
Changes in autophagy [Change from baseline at 5 years.]
Autophagy will be measured by autophagy-related mRNA gene expression evaluation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Primorska, Faculty of Health Sciences	Izola		Slovenia	SI-6310

Sponsors and Collaborators

University of Primorska

Investigators

Principal Investigator: Zala Jenko Pražnikar, PhD, University of Primorska, Faculty of Health Sciences
Principal Investigator: Nina Mohorko, PhD, University of Primorska, Faculty of Health Sciences