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

NCT05112276 | Completed

• 1 other identifier: Chalmers
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy, Overweight, Obese

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Triglycerides

  3 weeks, 6 weeks, 12 weeks and 18 weeks

• Cholesterol

  3 weeks, 6 weeks, 12 weeks and 18 weeks

• Low-density lipid protein

  3 weeks, 6 weeks, 12 weeks and 18 weeks

• High-density lipid protein

  3 weeks, 6 weeks, 12 weeks and 18 weeks

• Blood pressure

  3 weeks, 6 weeks, 12 weeks and 18 weeks

Study Arms (2)

Control Diet

ACTIVE COMPARATOR

Average Swedish diet

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.

Other: Diet

Interventions

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

Control Diet; Intervention Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chalmers University of Technology: lead

Study Sites (1)

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

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Rikard Landberg, Dr

  Chalmers University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: October 27, 2021
• Primary Completion: February 25, 2023
• Study Completion: February 25, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)