Climate Friendly and Ecological Food on Microbiota (CLEAR)

June 11, 2018 updated by: Mälardalen University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Västerås, Sweden, 721 23
        • Mälardalens University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Living in Västerås
  • Carnivores
  • Healthy

Exclusion Criteria:

  • Vegans

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
After 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
Baseline, after 4 weeks, after 8 weeks
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.
After 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mälardalen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katarina Bälter, PhD, Mälardalens högskola

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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