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OpenTrials
Completed

NCT Number: NCT05112276

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.

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Key information

Conditions

Healthy, Overweight, Obese Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Triglycerides

    Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks

    Investigate if fasting plasma triglycerides differ between control and intervention.

  2. Cholesterol

    Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks

    Investigate if fasting plasma cholesterol differ between control and intervention.

  3. Low-density lipid protein

    Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks

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

  4. High-density lipid protein

    Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks

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

  5. Blood pressure

    Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks

    Investigate if fasting blood pressure differ between control and intervention.

  6. Fasting glucose

    Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks

    Investigate if fasting plasma glucose differ between control and intervention.

  7. C-reactive protein

    Time frame: 3 weeks, 6 weeks, 12 weeks and 18 weeks

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

Sponsors and collaborators

Lead sponsor

Chalmers University of Technology

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2021
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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