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NCT Number: NCT04347213

The Link Between Diets and Health Indicators

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.

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Key information

Conditions

Healthy Diet Inflammation Microbiota Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Primorska, Faculty of Health Sciences

Izola, SI-6310, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular lifestyle in different circumstances

Behavioral

Participants' lifestyle will be followed over the years.

Primary outcomes

  1. Changes in systemic inflammation

    Time frame: Change from baseline at 5 years.

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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Changes in lifestyle factors

    Time frame: Change from baseline at 5 years.

    Will be assessed with a questionnaire.

  7. 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.

  8. 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).

  9. Changes in grip strength

    Time frame: Change from baseline at 5 years.

    Will be measured with a hand dynamometer.

  10. Changes in autophagy

    Time frame: Change from baseline at 5 years.

    Autophagy will be measured by autophagy-related mRNA gene expression evaluation.

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Registry information

Official study title

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

Acronym: DIETE

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 15, 2020
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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