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Climate Friendly and Ecological Food on Microbiota (CLEAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Sustainability Microbiota Pesticides Organic Food Other: Climate friendly diet Other: Organic diet Other: Climate friendly and organic diet Other: Control group (Control diet) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: An Intervention Study of Sustainable Food Habits That Promotes Health and Environmental Aspects
Actual Study Start Date : August 31, 2017
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : May 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pesticides

Arm Intervention/treatment
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.
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.

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.
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.

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.
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.

Placebo Comparator: Control group
The control group will receive instructions to eat according to the Nordic Nutrition Recommendations.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Living in Västerås
  • Carnivores
  • Healthy

Exclusion Criteria:

  • Vegans

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383510


Locations
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Sweden
Mälardalens University
Västerås, Sweden, 721 23
Sponsors and Collaborators
Mälardalen University
Investigators
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Principal Investigator: Katarina Bälter, PhD Mälardalens Högskola

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Responsible Party: Mälardalen University
ClinicalTrials.gov Identifier: NCT03383510    
Other Study ID Numbers: 2017/306
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No