NCT06490133Completed
Evaluation of Consuming Olive Extract on Total Cholesterol Levels
Nutritional Intervention to Evaluate the Effectiveness of the Consumption of Dehydrated Olive Pulp in Reducing Total Cholesterol Levels in Subjects with Overweight-obesity and High Total Cholesterol Levels
Source: ClinicalTrials.gov · Last updated 9 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 28 Jun 2024
- Start date
- 3 Apr 2024
- Primary completion date
- 8 Sept 2024
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Diseases
- Obesity
- NCT number
- NCT06490133
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 3 Apr 2024 to the primary completion date, 8 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects having undergone any surgical operation in th egastrointestinal tract with permanent consequences (i.e. gastroduodenectomy).
Other illness
- Any alteration of the Gastrointestinal system, functional or structural (gastric ulcer, chronic inflammatory diseases, hernia, etc.)
- Suffer from any metabolic disease or cancer process.
- Being allergic to any of the compounds contained in the study capsules.
- People with any mental impairment or whose compliance with the study protocol is at risk.
Other
- Subjects following any pharmacological treatment affecting gastric homeostasis.
- Excessive alcohol ingestion (14 units/day for women, or 20 units/day for men).
- Women lactating or during pregnancy.
- Following any cholesterol-lowering treatment.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigacion en Nutricion. Universidad de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.