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Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects

Primary Purpose

Healthy, Overweight, Obese

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Diet

About this trial

This is an interventional other trial for Healthy, Overweight, Obese

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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.

Exclusion Criteria:

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
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

Sites / Locations

University of Gothenburg, Department of Food and Nutrition and Sport Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Diet

Intervention Diet

Arm Description

Average Swedish diet

The intervention diet will be based on food items that have shown a beneficial effect on gut microbiota associated with cardiometabolic risk factors.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Triglycerides

Investigate if fasting plasma triglycerides differ between control and intervention.

Cholesterol

Investigate if fasting plasma cholesterol differ between control and intervention.

Low-density lipid protein

Investigate if fasting plasma Low-density lipid proteindiffer between control and intervention.

High-density lipid protein

Investigate if fasting plasma High-density lipid protein differ between control and intervention.

Blood pressure

Investigate if fasting blood pressure differ between control and intervention.

Fasting glucose

Investigate if fasting plasma glucose differ between control and intervention.

C-reactive protein

Investigate if fasting plasma C-reactive protein differ between control and intervention.

Full Information

NCT ID

NCT05112276

First Posted

October 27, 2021

Last Updated

August 30, 2023

Sponsor

Chalmers University of Technology

1. Study Identification

Unique Protocol Identification Number

NCT05112276

Brief Title

Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects

Official Title

Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

October 27, 2021 (Actual)

Primary Completion Date

February 25, 2023 (Actual)

Study Completion Date

February 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chalmers University of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Overweight, Obese

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Diet

Arm Type

Active Comparator

Arm Description

Average Swedish diet

Arm Title

Intervention Diet

Arm Type

Experimental

Arm Description

The intervention diet will be based on food items that have shown a beneficial effect on gut microbiota associated with cardiometabolic risk factors.

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Gut microbiome

Description

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.

Time Frame

6 weeks

Title

Gut microbiome

Description

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.

Time Frame

6 weeks, 18 weeks

Secondary Outcome Measure Information:

Title

Triglycerides

Description

Investigate if fasting plasma triglycerides differ between control and intervention.

Time Frame