Climate Friendly and Ecological Food on Microbiota

Microbiota Clinical Trial

— CLEAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383510
• Other study ID #: 2017/306
• Status: Completed
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: May 3, 2018

Study information

• Verified date: June 2018
• Source: Mälardalen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 3, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Living in Västerås

• Carnivores

• Healthy

Exclusion Criteria:

• Vegans

Related Conditions & MeSH terms

• Microbiota
• Organic Food
• Pesticides
• Sustainability

Intervention

Other:
• Climate friendly diet
Participants in the 'Climate friendly' group will be assigned a diet generating low emissions of greenhouse gases. The target is to reduce the participants' diet-related carbon dioxide equivalents (CO2e) to 2.5 kg per person and day, which is approximately a reduction by 50% compared the average CO2e, according to a previous study on diet-related CO2e in Sweden. The participants will be instructed to reduce their consumption of beef and dairy products and increase their consumption of plant-foods i.e. fruits, vegetables, legumes and whole-grain cereals.
• Organic diet
Participants in the 'Organic group' will be assigned an organic diet with very low, or no, content of pesticides. The participants will be instructed to replace at least 50% of their food intake with organic foods.
• Climate friendly and organic diet
The participants in the 'Climate friendly and organic diet group' will be assigned a combination of a climate friendly and organic diet generating low emissions of greenhouse gas and having very low levels of pesticides. The target is to reduce the participants' diet-related CO2e to 2.5 kg per person and day. The participants will be instructed to replace at least 50% of their food intake with organic products.
• Control group (Control diet)
A conventional diet according to the Nordic Nutrition Recommendations (NNR). The participants will get information about the present dietary guidelines and how they can adhere to the guidelines, for example, by implementing the "plate model" for meals and learning about recommended levels of intake of macronutrients, micronutrients, fiber and energy.

Locations

Country	Name	City	State
Sweden	Mälardalens University	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Mälardalen University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in composition of the microbiota	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.	Baseline, after 4 weeks, after 8 weeks
Primary	Changes in concentration of pesticide residues in urine	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of energy	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.	After 8 weeks
Secondary	Changes in intake of protein	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of fat	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of carbohydrates	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of dietary fiber	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of vitamin A	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of vitamin D	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of vitamin E	The investigators will assess changes in intake of vitamin E, measured in alpha-tocopherol equivalents per day (a-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 a-TE by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of thiamin	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of riboflavin	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of niacin	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of vitamin B6	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of folate	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of vitamin B12	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of vitamin C	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of calcium	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of phosphorus	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of potassium	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of iron	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of zinc	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of iodine	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of selenium	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Changes in intake of copper	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.	Baseline, after 4 weeks, after 8 weeks
Secondary	Assessment of the participants likeability of the diets using a questionnaire	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.	After 8 weeks