MedPath

The Link Between Diets and Health Indicators

Completed
Conditions
Healthy Diet
Microbiota
Interventions
Behavioral: Regular lifestyle in different circumstances
Registration Number
NCT04347213
Lead Sponsor
University of Primorska
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
low-carbohydrate high-fat dietRegular lifestyle in different circumstancesParticipants who habitually avoid carbohydrate in their diet.
omnivorsRegular lifestyle in different circumstancesParticipants who habitually consume all food groups in their diet.
vegetarianRegular lifestyle in different circumstancesParticipants who habitually avoid meat in their diet.
veganRegular lifestyle in different circumstancesParticipants who habitually avoid all animal source food in their diet.
Primary Outcome Measures
NameTimeMethod
Changes in systemic inflammationChange from baseline at 5 years.

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

Changes in serum total antioxidative capacityChange 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
NameTimeMethod
Changes in gut microbiota compositionChange from baseline at 5 years.

Microbial composition of stool will be determined with microbial DNA isolation and identification.

Changes in autophagyChange from baseline at 5 years.

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

Changes in grip strengthChange from baseline at 5 years.

Will be measured with a hand dynamometer.

Changes in micronutrient intakeChange 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 lifestyle factorsChange from baseline at 5 years.

Will be assessed with a questionnaire.

Changes in macronutrient intakeChange 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 body compositionChange from baseline at 5 years.

Fat free body mass will be measured with bioelectrical impedance analysis and expressed in kg.

Changes in resting metabolic rateChange from baseline at 5 years.

Resting metabolic rate will be determined with indirect calorimeter and expressed in kJ/day.

Changes in anxietyChange 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 satisfactionChange 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).

Trial Locations

Locations (1)

University of Primorska, Faculty of Health Sciences

🇸🇮

Izola, Slovenia

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