Biomarker pAtterns Reflecting habITual fOod iNtakE: the BARITONE Project

NCT07128940 | Not Yet Recruiting

• 1 other identifier: BARITONE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The BARITONE study's overall aim is to understand how our eating habits affect our long-term health. By identifying biological traces in blood, urine and other samples - so-called biomarkers - the investigators want to be able to see what people actually eat, such as protein from different food sources as well as fruit, berries and vegetables. These biomarkers could in the future improve the possibilities to find out how dietary habits affect the risk of disease. The investigators are targeting healthy people who are interested in participating in research on biomarkers of dietary intake. The research is divided into a cross-sectional study, where the investigators collect data on the participant's usual dietary intake, health and biological samples at the screening visit, and an cross over intervention study that involves eating three different diets (meat, fish, vegetarian) for a total of 3 weeks with one week wash-out in between.

Conditions

Healthy

Keywords

food; biomarker; metabolomics; fruit and vegetables; meat; fish; plant based protein; whole grain

Outcome Measures

Primary Outcomes (1)

• Patterns of metabolites in plasma/serum

  Metabolites analysed by LC-MS/GC-MS or NMR for metabolomics studies (changes in patterns of metabolites). Metabolite patterns will be compared by multivariate methods such as HDA-OPLS between the three diets. Metabolite patterns will be compared by multivariate methods such as OPLS-DA comparing high and low intake of vegetables, fruit and berries.

  1 week

Secondary Outcomes (3)

• Patterns of lipids

  1 week

• Patterns of metabolites in urine

  1 week

• Class disciminating metabolites in plasma/serum

  1 week

Other Outcomes (13)

• Fatty acid patterns in plasma

  screening

• Fatty acids in erythrocytes

  screening

• Body mass index (BMI) (kg/m2)

  1 week

Study Arms (3)

Meat

EXPERIMENTAL

All food provided for a week, including a variety of meat

Other: Meat vs fish; Other: Meat vs Vegetarian

Fish

EXPERIMENTAL

All food provided for a week, including a variety of fish and shellfish

Other: Meat vs fish; Other: Fish vs Vegetarian

Vegetarian

EXPERIMENTAL

All food provided for a week, diet (no fish or meat)

Other: Meat vs Vegetarian; Other: Fish vs Vegetarian

Interventions

Meat vs fish OTHER

Metabolite differences: Meat vs fish

Fish; Meat

Meat vs Vegetarian OTHER

Metabolite differences: Meat vs Vegetarian

Meat; Vegetarian

Fish vs Vegetarian OTHER

Metabolite differences: Fish vs Vegetarian

Fish; Vegetarian

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult
• years
• BMI 18.5-30 kg/m²
• Willing to consume the three diets i.e. meat, fish, and vegetarian
• Understands Swedish
• Low intake of vegetables, fruit and berries (lowest tertile of screened participants, estimated \<100g day) or high intake of vegetables, fruit and berries (highest tertile of screened participants, estimated \>400g day)

You may not qualify if:

• Pregnancy and lactation
• Diagnosis of cancer or other life threatening diseases
• Diagnosis of metabolic or food related diseases inluding diabetes, inflammatory bowel disease, hypothyroidism or celiak disease.
• Medication that influences the metabolism such as blood lipid lowering medication, insulin, etc.
• Use of drugs other than medication and alcohol
• Nicotine use (snuff, vaping and smoking)

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

University of Gothenburg

Gothenburg, 405 30, Sweden

Location

Central Study Contacts

Helen M Lindqvist, Docent

CONTACT

+46317863723; helen.lindqvist@gu.se

Anna Winkvist, Professor

CONTACT

anna.winkvist@nutrition.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: August 19, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)