Climate Friendly and Ecological Food on Microbiota

Study Overview
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Brief Summary
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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.

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

Conditions
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Sustainability, Microbiota, Pesticides, Organic Food

Intervention / Treatment
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* Other: Climate friendly diet
* Other: Organic diet
* Other: Climate friendly and organic diet
* Other: Control group (Control diet)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living in Västerås Carnivores Healthy Exclusion Criteria: Vegans

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Climate friendly group<br>The climate friendly group will receive instructions to eat according to a climate friendly diet, i.e., to replace the majority of their intake of animal based products with plant based food. | Other: Climate friendly diet<br>* 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.<br>|
| Experimental: Organic group<br>The organic group will receive instructions to eat an organic diet, i.e., to replace at least 50% of their normally consumed food with organic equivalents. | Other: Organic diet<br>* 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.<br>|
| Experimental: Climate friendly and organic group<br>The climate friendly and organic group will receive instructions to consume a climate friendly and organic diet, i.e, to replace the majority of their intake of animal based products with plant based food AND to consume at least 50% organic food products. | Other: Climate friendly and organic diet<br>* 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.<br>|
| Placebo Comparator: Control group<br>The control group will receive instructions to eat according to the Nordic Nutrition Recommendations. | Other: Control group (Control diet)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Changes in intake of vitamin E | 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. | Baseline, after 4 weeks, after 8 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |