The Link Between Diets and Health Indicators (DIETE)

August 7, 2023 updated by: Zala Jenko Praznikar, University of Primorska

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Izola, Slovenia, SI-6310
        • University of Primorska, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in systemic inflammation
Time Frame: Change from baseline at 5 years.
CRP [mg/L] will be measured as a marker of inflammation.
Change from baseline at 5 years.
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.
Change from baseline at 5 years.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2020

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DIETE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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