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Clinical Trials/NCT03383510
NCT03383510
Completed
Not Applicable

An Intervention Study of Sustainable Food Habits That Promotes Health and Environmental Aspects

Mälardalen University1 site in 1 country39 target enrollmentAugust 31, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sustainability
Sponsor
Mälardalen University
Enrollment
39
Locations
1
Primary Endpoint
Changes in concentration of pesticide residues in urine
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to investigate changes in nutrient intake, the human gut microbiota and pesticide excretion in urine when shifting from conventional food habits to sustainable food habits.

Registry
clinicaltrials.gov
Start Date
August 31, 2017
End Date
May 3, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mälardalen University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Living in Västerås
  • Carnivores

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in concentration of pesticide residues in urine

Time Frame: Baseline, after 4 weeks, after 8 weeks

The investigators will assess changes in concentration of four pesticide residues (Mepiquat, Chlormequat, Propamocarb and Ethylene thiourea) excreted in urine. Samples will be collected at three occasions; baseline (reference sample), midtime (after 4 weeks) and at the end (after 8 weeks). The concentration of pesticide residues in urine samples will be determined in normal or reversed phase configuration on a high performance liquid chromatograph coupled to a triple quadrupole mass spectrometer (HPLC-MS/MS) system with electrospray ionization interface (ESI) run in negative or positive mode.

Changes in composition of the microbiota

Time Frame: Baseline, after 4 weeks, after 8 weeks

The investigators will assess changes over time in the presence of all gut bacteria species in the microbiome of the participants based on DNA sequencing from fecal samples. Samples will be collected at three occasions; baseline (reference sample), midtime (after 4 weeks) and at the end (after 8 weeks). From frozen samples, all DNA will be extracted and full shotgun metagenomic sequencing performed using next generation sequencing technologies (Illumina and BGISEQ). A total of 120 samples (3\*40 participants) will be sequenced to a depth of at least 3 giga base pairs (Gbp) each.

Secondary Outcomes

  • Changes in intake of zinc(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of selenium(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of fat(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of thiamin(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of riboflavin(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of carbohydrates(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of vitamin E(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of niacin(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of vitamin B6(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of iodine(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of energy(After 8 weeks)
  • Changes in intake of protein(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of dietary fiber(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of vitamin A(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of vitamin D(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of folate(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of vitamin C(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of iron(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of calcium(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of phosphorus(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of vitamin B12(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of potassium(Baseline, after 4 weeks, after 8 weeks)
  • Changes in intake of copper(Baseline, after 4 weeks, after 8 weeks)
  • Assessment of the participants likeability of the diets using a questionnaire(After 8 weeks)

Study Sites (1)

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