Healthy, Overweight, ObeseNCT05112276
Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects
A study testing Diet in people with Healthy, Overweight, Obese, run by Chalmers University of Technology at 1 site in Sweden.
Trial summary
The overall aim in this "proof-of-concept" study is to evaluate if a diet concept, based on foods that have individually been reported to beneficially affect gut microbiota in fact has an effect on gut microbiota composition and activity among healthy and obese subjects and whether the effects are associated with… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight, Obese
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 27 Oct 2021to 25 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Age 18 - 70 years
- BMI 18,5-25 for normal weighed and BMI 25-39 for overweighed/obese
- Hb ≥ 120g/L
- Serum TSH <4,0 mIU/L
- Signed informed consent
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- Among the overweighed, they need to have waist circumference > 102 cm/88 cm for men and women respectively. All overweighed participants must have one of the following risk factors for cardiovascular decease, whereas the normal weighed could have or not elevated risk factors:
- LDL ≥ 3,0 mmol/L
- HDL ≤1.04 mmol/L
- Total cholesterol ≥ 5.0 mmol/L
- Triglycerider ≥1.69 mmol/L
- Blood pressure ≥130/85 mmHg
- Fasting glucose ≥6.1 mmol/L.
Who cannot join
- Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
- Following any weight reduction program or having followed one during the last 6 months
- Food allergies or intolerances
- Vegetarian or other diet restrictions (due to the standardized meal plan)
- History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
- Previous major gastrointestinal surgery
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- Pregnant or lactating or wish to become pregnant during the period of the study.
- Unable to understand written and spoken Swedish
- Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI.
- Pharmacological medication with drugs known to affect the microbiota, e.g. antibiotics, within 6 months prior to baseline.
- Intake of probiotics within 6 months prior to baseline.
- Have type I diabetes
- Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as it is compatible with the study protocol)
- Using nicotine products on a daily basis (including chewing gum, patches, snus etc.)
- History of heart failure or heart attack (TIA) within 1 year prior to screening
- Thyroid disorder
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University of Gothenburg, Department of Food and Nutrition and Sport Science
Gothenburg
About this study
The overall aim in this "proof-of-concept" study is to evaluate if a diet concept, based on foods that have individually been reported to beneficially affect gut microbiota in fact has an effect on gut microbiota composition and activity among healthy and obese subjects and whether the effects are associated with altered cardiometabolic risk factors. The aim is further to investigate if such alterations are reflected in changes of the fecal and plasma metabolome. In total, 40 men and women, who meet all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. The participants will follow an intervention diet for 6 weeks and a control diet for 6 weeks, with a 6-week wash-out period in between and will be randomized to either begin with the intervention diet or the control diet.
The study will be running over 18 weeks (including a 6-week wash-out period) and it will include 9 visits at the clinic.
- Conditions
- Healthy, Overweight, Obese
- Being tested
- Diet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
A review has been undertaken to both identify specific bacteria associated with cardiometabolic risk factors and food items that have been shown to affect such bacteria in a beneficial direction. The intervention diet will include a variety of food items e.g. vegetables, fermented vegetables, fermented dairy products and cereal products. The control diet is based on a Swedish Average Diet
| Study group | Role | What they receive |
|---|---|---|
| Control Diet | Active comparator | Average Swedish diet Receives: Other: Diet |
| Intervention Diet | Experimental | The intervention diet will be based on food items that have shown a beneficial effect on gut microbiota associated with cardiometabolic risk factors. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome
Fecal samples will analyzed for composition of the gut microbiome. Difference in gut microbiota OTUs between the two diets. Baseline compared with after 6 weeks of intervention or control.
Measured: 6 weeks
Gut microbiome
Fecal samples will analyzed for composition of the gut microbiome. Change in gut microbiota OTUs between baseline and 6 and 18 weeks of intervention or control.
Measured: 6 weeks, 18 weeks
Secondary outcomes (7)
Triglycerides
Investigate if fasting plasma triglycerides differ between control and intervention.
Measured: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Cholesterol
Investigate if fasting plasma cholesterol differ between control and intervention.
Measured: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Low-density lipid protein
Investigate if fasting plasma Low-density lipid proteindiffer between control and intervention.
Measured: 3 weeks, 6 weeks, 12 weeks and 18 weeks
High-density lipid protein
Investigate if fasting plasma High-density lipid protein differ between control and intervention.
Measured: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Blood pressure
Investigate if fasting blood pressure differ between control and intervention.
Measured: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Fasting glucose
Investigate if fasting plasma glucose differ between control and intervention.
Measured: 3 weeks, 6 weeks, 12 weeks and 18 weeks
C-reactive protein
Investigate if fasting plasma C-reactive protein differ between control and intervention.
Measured: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start27 Oct 2021
- Primary completion25 Feb 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, Overweight, ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
- Investigators
- Rikard Landberg, Dr, Principal investigator, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112276
- Sponsor's protocol ID
- Chalmers
- Status last verified
- Aug 2023
- First submitted
- 27 Oct 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects
- ClinicalTrials.gov ID
- NCT05112276
- Acronym / sponsor ID
- Chalmers
- Conditions
- Healthy, Overweight, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim in this "proof-of-concept" study is to evaluate if a diet concept, based on foods that have individually been reported to beneficially affect gut microbiota in fact has an effect on gut microbiota composition and activity among healthy and obese subjects and whether the effects are associated with altered cardiometabolic risk factors. The aim is further to investigate if such alterations are reflected in changes of the fecal and plasma metabolome. In total, 40 men and women, who meet all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. The participants will follow an intervention diet for 6 weeks and a control diet for 6 weeks, with a 6-week wash-out period in between and will be randomized to either begin with the intervention diet or the control diet.
The study will be running over 18 weeks (including a 6-week wash-out period) and it will include 9 visits at the clinic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Diet | Active comparator | Other: DietAverage Swedish diet |
| Intervention Diet | Experimental | Other: DietThe intervention diet will be based on food items that have shown a beneficial effect on gut microbiota associated with cardiometabolic risk factors. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Men and women
- Age 18 - 70 years
- BMI 18,5-25 for normal weighed and BMI 25-39 for overweighed/obese
- Hb ≥ 120g/L
- Serum TSH <4,0 mIU/L
Key exclusion criteria (16 listed)
- Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
- Following any weight reduction program or having followed one during the last 6 months
- Food allergies or intolerances
- Vegetarian or other diet restrictions (due to the standardized meal plan)
- History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietA review has been undertaken to both identify specific bacteria associated with cardiometabolic risk factors and food items that have been shown to affect such bacteria in a beneficial direction. The intervention diet will include a variety of food items e.g. vegetables, fermented vegetables, fermented dairy products and cereal products. The control diet is based on a Swedish Average Diet | Other | Control Diet, Intervention Diet |
Primary outcome
Gut microbiome
Time frame: 6 weeks
Fecal samples will analyzed for composition of the gut microbiome. Difference in gut microbiota OTUs between the two diets. Baseline compared with after 6 weeks of intervention or control.
Gut microbiome
Time frame: 6 weeks, 18 weeks
Fecal samples will analyzed for composition of the gut microbiome. Change in gut microbiota OTUs between baseline and 6 and 18 weeks of intervention or control.
7 secondary outcomes
Triglycerides
Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Cholesterol
Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Low-density lipid protein
Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks
High-density lipid protein
Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Blood pressure
Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Fasting glucose
Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks
C-reactive protein
Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikard Landberg, Dr principal investigator
Chalmers University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Healthy, Overweight, Obese, run by Chalmers University of Technology at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.