Climate Friendly and Ecological Food on Microbiota

Not Applicable

Completed

• Conditions: Sustainability; Microbiota; Pesticides; Organic Food

• Registration Number: NCT03383510
• Lead Sponsor: Mälardalen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-31
• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-26
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Living in Västerås
• Carnivores
• Healthy

Exclusion Criteria

• Vegans

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in concentration of pesticide residues in urine	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	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 Outcome Measures

Name	Time	Method
Changes in intake of niacin	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of niacin, measured in Niacin Equivalents per day (NE/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of niacin in NE by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of vitamin B6	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of vitamin B6, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin B6 in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of iodine	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of iodine, measured in μg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of iodine in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of zinc	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of zinc, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of zinc in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of selenium	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of selenium, measured in μg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of selenium in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of fat	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of fat in kJ/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of fat in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of thiamin	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of thiamin, measured in milligrams per day (mg/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of thiamin in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of riboflavin	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of riboflavin, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of riboflavin in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of carbohydrates	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of carbohydrates in kJ/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of macronutrients in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of vitamin E	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of vitamin E, measured in alpha-tocopherol equivalents per day (α-TE/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin E in α-TE by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of energy	After 8 weeks	The investigators will assess changes in intake of energy in kilojoule/day (kJ/day) when the participants shifts their diet from conventional food habits to sustainable food habits, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of energy in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of protein	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of protein in kJ/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of protein in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of dietary fiber	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of dietary fiber in kJ/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of dietary fiber in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of vitamin A	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of vitamin A, measured in Retinol Equivalents per day (RE/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin A in RE by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of vitamin D	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of vitamin D, measured in micrograms per day (μg/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin D in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of folate	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of folate, measured in μg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of folate in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of vitamin C	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of vitamin C, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin C in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of iron	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of iron, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of iron in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of calcium	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of calcium, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of calcium in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of phosphorus	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of phosphorus, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of phosphorus in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of vitamin B12	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of vitamin B12, measured in μg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin B12 in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of potassium	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of potassium, measured in grams per day (g/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of potassium in g by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Changes in intake of copper	Baseline, after 4 weeks, after 8 weeks	The investigators will assess changes in intake of copper, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of copper in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Assessment of the participants likeability of the diets using a questionnaire	After 8 weeks	The investigators will assess the participants "likeability" of the diets by asking how likely they are to continue to adhere to them after the end of the intervention.

Trial Locations

Locations (1)

Mälardalens University; 🇸🇪 Västerås, Sweden