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

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 Overview

• Status: Completed
• Conditions: Healthy, Overweight, Obese
• Intervention / Treatment: Other: Diet

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Diet; Average Swedish diet	Other: Diet; 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
Experimental: Intervention Diet; The intervention diet will be based on food items that have shown a beneficial effect on gut microbiota associated with cardiometabolic risk factors.	Other: Diet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 weeks, 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides	Investigate if fasting plasma triglycerides differ between control and intervention.	3 weeks, 6 weeks, 12 weeks and 18 weeks
Cholesterol	Investigate if fasting plasma cholesterol differ between control and intervention.	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.	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.	3 weeks, 6 weeks, 12 weeks and 18 weeks
Blood pressure	Investigate if fasting blood pressure differ between control and intervention.	3 weeks, 6 weeks, 12 weeks and 18 weeks
Fasting glucose	Investigate if fasting plasma glucose differ between control and intervention.	3 weeks, 6 weeks, 12 weeks and 18 weeks
C-reactive protein	Investigate if fasting plasma C-reactive protein differ between control and intervention.	3 weeks, 6 weeks, 12 weeks and 18 weeks

Collaborators and Investigators

• Sponsor: Chalmers University of Technology
• Investigators: Principal Investigator: Rikard Landberg, Dr, Chalmers University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): February 25, 2023
• Study Completion (Actual): February 25, 2023

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: Chalmers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No