Management of metabolic risk factors of metabolic syndrome Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 05/11/2021: Patients: Presenting with at least two of the following risk factors of metabolic syndrome: 1. Hypertension (systolic BP =130 mmHg or diastolic BP >85 mmHg) 2. Hypercholesterolemia (HDL colesterol 150 mg/dl) 4. Increased fasting plasma glucose (>100 mg/dl) 5. Increased waist circumference (>94 cm in men and >80 cm in women) Healthy participants: Presenting with normal values of the parameters mentioned above. Previous participant inclusion criteria: Participants have to present at least two of the following risk factors of metabolic syndrome: 1. Hypertension (systolic BP =130 mmHg or diastolic BP >85 mmHg) 2. Hypercholesterolemia (HDL colesterol 150 mg/dl) 4. Increased fasting plasma glucose (>100 mg/dl) 5. Increased waist circumference (>94 cm in men and >80 cm in women)
Exclusion criteria
Exclusion criteria: 1. Serious cardiovascular disease 2. Antibiotic intake up to 3 months before the study 3. Endocrine and gastrointestinal disorders 4. Addiction to drugs or alcohol 5. Restrictive diets (vegetarians, vegans)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Full serum count, erythrocyte sedimentation rate, c-reactive protein, sodium, potassium, chloride, bicarbonate, urea, creatinine, bilirubin, gamma-glutamyl transferase, total protein, albumin, calcium, phosphate, uric acid, random blood glucose, cholesterol, high-density lipoprotein, low-density lipoprotein and triglycerides; measured using a blood test at baseline and at the end of the control/intervention period 2. Blood pressure (mmHg), height (cm), weight (kg), waist diameter (cm) and hip circumference (cm) measured at baseline and at the end of the control/intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Short-chain fatty acids (SCFA) and phenolic metabolites analysed in faecal samples by gas chromatography–mass spectrometry (GC-MS) and ultra-high performance liquid chromatography mass spectrometry (UHPLC–MS), respectively, according to previous laboratory procedures at baseline and at the end of the control/intervention period 2. Microbiota sequencing analysis of faecal samples following a bacteria metagenomic approach (Illumina technology) at baseline and at the end of the control/intervention period | — |
Countries
Spain