Clinical trial NCT06587958: Fermented Plant-based Portfolio Diet 4 Metabolic Health
Official title: Fermented Plant-based Portfolio Diet 4 Metabolic Health (FermDiHealth)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Cardiovascular Syndrome
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Göteborg University
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A three-way randomized controlled crossover study will investigate the effects of fermented plant-based foods, non-fermented plant-based foods and the habitual diet on cardiometabolic risk factors. Each intervention will be ongoing for six weeks with six weeks washout in-between. During the fermented/non-fermented plant-based foods intervention, participants will add several corresponding food products to their habitual diet. The study has been dimensioned based on the estimated effect on hsCRP.
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to evaluate the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a corresponding non-fermented plant-based diet and a control diet (habitual diet). This will be assessed across gut microbiome profiles (high/low Prevotella), focusing on cardiometabolic risk factors, particularly inflammation.

A total of 100 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will employ a three-way randomized, controlled cross-over design, featuring six-week interventions separated by six-week washout periods. Participants will attend the clinic on 15 occasions, including screening visits.


Eligibility criteria: Inclusion Criteria:

* Sign of metabolic syndrome

Waist circumference \> 102 cm/88 cm M/W and at least one of the following:

* High density lipoprotein (HDL) ≤1.0 mmol/L men / HDL ≤1.3 mmol/L
* Triglycerides ≥ 1,7 mmol/L
* Blood pressure ≥130/85 mmHg
* Fasting glucose ≥5.6 mmol/L

Other inclusion criteria:

* Signed informed consent
* Willingness to consume the intervention foods
* Body mass index 25-35 kg/m2
* Hemoglobin 120-160 g/L
* Serum thyroid-stimulating hormone (S-TSH) \<4 mIU/L
* Serum C-reactive protein (S-CRP) \<5 mg/L
* Access to a -18⁰ C freezer
* Any medication stable for the last 14 days.

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
* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery, Helicobacter infection, Peptic ulcer disease, untreated celiac disease, 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 any probiotic pills or foods enriched in probiotics within 6 months prior to baseline.
* Type I diabetes
* Small bowel bacterial overgrowth
* Diarrheal disease
* Receiving pharmacological treatment for type II diabetes (treatments based on lifestyle 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
* Planned surgery within the next eight months

Primary outcomes:
measure: C-reactive protein
timeFrame: 6 weeks
Secondary outcomes:
measure: Glucose
timeFrame: 6 weeks
measure: Insulin
timeFrame: 6 weeks
measure: Liver parameters
timeFrame: 6 weeks
measure: Glycaemic variability
timeFrame: 2 weeks
measure: Mixed meal tolerance test
timeFrame: 1-day
measure: Gut microbiome
timeFrame: 6 weeks
measure: Blood pressure
timeFrame: 6 weeks
measure: Blood lipid profile
timeFrame: 6 weeks
Other outcomes:
measure: The metabolome
timeFrame: 6 weeks
measure: Gut microbiome profiles
timeFrame: 6 weeks
measure: Transit time
timeFrame: 5-days
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Wallenberg Lab
state: ästra Götaland
Study officials:
affiliation: Chalmers Univeristy of Technology
name: Rikard Landberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: