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Climate Friendly and Ecological Food on Microbiota (CLEAR)

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ClinicalTrials.gov Identifier: NCT03383510
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Mälardalen University

Tracking Information
First Submitted Date  ICMJE September 29, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE August 31, 2017
Actual Primary Completion Date May 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • 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 3Gbp each.
  • 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, Clormequat, Propamocarb and Ethyline 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 in negative or positive mode.
  • Changes in intake of macronutrients [ Time Frame: Baseline, after 4 weeks, after 8 weeks ]
    The investigators will assess changes in intake of macronutrients (in kJ/day) when the participants shifts their diet from conventional food habits to sustainable food habits, using 24 h recalls and food frequency questionnaires.
  • Changes in intake of micronutrients [ Time Frame: Baseline, after 4 weeks, after 8 weeks ]
    The investigators will assess changes in intake of micronutrients (in μg and mg/day) when the participants shifts their diet from conventional food habits to sustainable food habits, using 24 h recalls and food frequency questionnaires.
  • Changes in intake of dietary fiber [ Time Frame: Baseline, after 4 weeks, after 8 weeks ]
    The investigators will assess changes in intake of macronutrients (in g/day and g/MJ/day) when the participants shifts their diet from conventional food habits to sustainable food habits, using 24 h recalls and food frequency questionnaires.
  • Changes in intake of energy [ Time Frame: Baseline, after 4 weeks, after 8 weeks ]
    The investigators will assess changes in intake of energy (in kJ/day and kcal/day) when the participants shifts their diet from conventional food habits to sustainable food habits, using 24 h recalls and food frequency questionnaires.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • Changes in intake of energy [ Time Frame: 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 [ Time Frame: 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 fat [ Time Frame: 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 carbohydrates [ Time Frame: 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 dietary fiber [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 vitamin E [ Time Frame: 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 thiamin [ Time Frame: 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 [ Time Frame: 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 niacin [ Time Frame: 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 [ Time Frame: 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 folate [ Time Frame: 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 B12 [ Time Frame: 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 vitamin C [ Time Frame: 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 calcium [ Time Frame: 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 [ Time Frame: 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 potassium [ Time Frame: 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 iron [ Time Frame: 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 zinc [ Time Frame: 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 iodine [ Time Frame: 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 selenium [ Time Frame: 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 copper [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
Assessment of the participants likeability of the diets using a questionnaire [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Climate Friendly and Ecological Food on Microbiota
Official Title  ICMJE An Intervention Study of Sustainable Food Habits That Promotes Health and Environmental Aspects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Sustainability
  • Microbiota
  • Pesticides
  • Organic Food
Intervention  ICMJE
  • 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.
  • Other: 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.
  • Other: 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.
  • Other: 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.
Study Arms  ICMJE
  • Experimental: Climate friendly group
    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.
    Intervention: Other: Climate friendly diet
  • Experimental: Organic group
    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.
    Intervention: Other: Organic diet
  • Experimental: Climate friendly and organic group
    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.
    Intervention: Other: Climate friendly and organic diet
  • Placebo Comparator: Control group
    The control group will receive instructions to eat according to the Nordic Nutrition Recommendations.
    Intervention: Other: Control group (Control diet)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2018)
39
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2017)
40
Actual Study Completion Date  ICMJE May 3, 2018
Actual Primary Completion Date May 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Living in Västerås
  • Carnivores
  • Healthy

Exclusion Criteria:

  • Vegans
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03383510
Other Study ID Numbers  ICMJE 2017/306
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mälardalen University
Study Sponsor  ICMJE Mälardalen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katarina Bälter, PhD Mälardalens Högskola
PRS Account Mälardalen University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP