Metabolic syndrome Nutritional, Metabolic, Endocrine
Conditions
Interventions
A sequence from 1 to 80 was randomly assigned to group "A" or "B" by a pseudo-random number generator. In order to assure that the "A" or "B" was not concentrate at the beginning or at the end, the se
Sponsors
The Carlos III Health Institute (Instituto De Salud Carlos III) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 30-75 years 2. Meets metabolic syndrome criteria, with at least 3 of the following: 2.1. Triglycerides =50 mg/dl or taking medication for hypertriglyceridemia (e.g. fibrates) 2.2. Glycemia =100 mg/dl or taking medication to reduce it 2.3. High blood pressure, i.e. =130/85 mmHg or taking antihypertensive medication 2.4. HDL cholesterol <40 mg/dL in men or <50 mg/dL in women or taking medication for treatment (e.g. nicotinic acid/niacin) 2.5. Waist circumference =102 cm in men or =88 cm in women
Exclusion criteria
Exclusion criteria: 1. Use of antibiotics, prebiotics or probiotics 3 months before starting the study 2. Diagnosis of celiac disease 3. Diagnosis of inflammatory bowel disease (IBD) 4. History of intestinal resection 5. Any serious active disease that might prevent the participant adequately following the study 6. Alcoholism or active drug addiction 7. Use that cannot be stopped for the study of non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressant agents, antibiotics and proton pump inhibitors 8. Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following measures will be recorded at the beginning and end of the intervention (8 weeks), for all participants: 1. Analysis of gut microbiome in terms of diversity (number of different bacterial species present in the samples) and richness (abundance of each species) microbial using a high sensitivity approach (sequencing with Illumina® technology) and quantitative PCR of stool samples. Species such as Faecalibacterium prausnitzii, Escherichia coli, Roseburia, Akkermansia, Lactobacillus, Bifidobacterium, Firmicutes, Bacteroidetes and total Eubacteria will be quantified and the index of intestinal dysbiosis defined by the ratio Faecalibacterium prausnutzii:Escherichia coli will be calculated. 2. Lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) and blood glucose levels measurements will be conducted by enzymatic methodologies using a PENTRA-400 analyzer(Horiba-Diagnostics) 3. C-reactive protein will be measured by immunoturbidimetry using a PENTRA-400 analyzer 4. Inflammation markers (interleukin 6 and 8, soluble VCAM, soluble ICAM, tumor necrosis factor and interferon gamma) will be analyzed using xMAP® technology from Luminex® in a BioPlex system (Bio-Rad, Hercules, California, United States) 5. Metabolic hormones (insulin, ghrelin, leptin, GLP-1, PYY, glycagon) will be analyzed using xMAP® technology from Luminex® in a BioPlex system (Bio-Rad, Hercules, California, United States). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following measures will be recorded at the beginning and end of the intervention (8 weeks), for all participants: 1. Weight: Individuals will wear light clothing without shoes and will be weighed with a high-quality electronic scale (calibrated every 3 months with a unit of known mass). The weight will be expressed in kg with a decimal, rounded to the value of 100 g 2. Height: Individuals should remove their shoes and jackets. The height will be measured standing with a stadiometer with an accuracy of 1 cm. The values will be expressed in cm. 3. Waist circumference. The volunteer will be placed horizontally with clothing that does not compress the abdomen. The abdominal perimeter will be measured in expiration at the intermediate level between the last rib and the iliac cretae, at the most prominent point of the trochanter. 4. Hip circumference. The volunteer will be placed horizontally with clothing that does not compress the abdomen. The maximum circumference at the level of the buttocks will be recorded in cm. The waist/hip index will be calculated. 5. Blood pressure. Volunteers should sit in a chair with their backs and arms supported in a situation that allows the armband to be at the level of the heart. Volunteers should avoid smoking or taking caffeine during the 30 min prior to blood pressure determination. The measurement should be started at least after 5 min of rest. The determinations should be made with a mercury sphygmomanometer. Blood pressure measurements will be determined in duplicate (separated by 1 min between them) and after 5 min of rest. The arm with the highest mean diastolic blood pressure will be the one chosen for the rest of the determinations throughout the study. Two or more readings should be averaged, if the first two differ more than 5 mmHg, additional readings should be obtained and averaged. 6. Blood levels of high-sensitivity C-reac | — |
Countries
Spain
Outcome results
None listed