Metabolic Syndrome | Serum or Plasma | Chemistry - Non-Challenge, Overweight
Conditions
Keywords
polyhpenols from olives, metabolic syndrome, cholesterol, lifestyle
Brief summary
The main objective of this nutritional intervention is to assess the efficacy of polyphenol-rich capsules on reducing metabolic syndrome traits, mainly cholesterol levels. For this purpose, a double blind, placebo controlled study of 12 weeks will be carried out. The target population is women and men with overweight or obesity. Researchers will compare the experimental capsules with placebo capsules, but will be blinded during the intervention and results analyses. Only after analysing the parameters, the groups will be revealed.
Interventions
DIETARY_SUPPLEMENTPolyhpenol extract
Three capsules in fasting conditions 15 minutes prior breakfast
DIETARY_SUPPLEMENTPlacebo
Three capsules in fasting conditions 15 minutes before breakfast
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel groups double blind, 12-week nutritional intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 25 and 35 Kg/m2 * Total Cholesterol levels in peripheral blood above or equal to 200 mg/dL or LDL-cholesterol levels above or equal to 160 mg/dL. * Weight stability during the three months prior the start of the study (±5% of variation). * To be able to attend the visits and accomplish with all the indications of the research staff. * To have signed the written informed consent.
Exclusion criteria
* Any alteration of the Gastrointestinal system, functional or structural (gastric ulcer, chronic inflammatory diseases, hernia, etc.) * Subjects having undergone any surgical operation in th egastrointestinal tract with permanent consequences (i.e. gastroduodenectomy). * Subjects following any pharmacological treatment affecting gastric homeostasis. * Suffer from any metabolic disease or cancer process. * Being allergic to any of the compounds contained in the study capsules. * Excessive alcohol ingestion (14 units/day for women, or 20 units/day for men). * Women lactating or during pregnancy. * Following any cholesterol-lowering treatment. * People with any mental impairment or whose compliance with the study protocol is at risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total cholesterol | Baseline | Serum concentration of Total Cholesterol |
| HDL cholesterol | Baseline | Serum concentration of HDL cholesterol |
| LDL cholesterol | Baseline | Serum Calculated LDL Cholesterol levels |
| Triglycerides | Baseline | Serum Triglycerides levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | Baseline | Hemoglobin measured as mg/dL |
| Blood pressure | Baseline | Measured in the dominant arm (mmHg) |
| Physical Activity | Baseline | Measured through the IPAQ questionnaire |
| Hematocrit | Baseline | Hematocrit (%) |
| Dietary intake | Baseline | FFQ from the SUN Study |
| Weight | Baseline | Weight status |
| Fat mass | Baseline | Fat mass in kg, measured by Bioimpedance |
Countries
Spain
Outcome results
None listed