Metabolic Syndrome | Serum or Plasma | Chemistry - Non-ChallengeOLICOLNCT06490133
Evaluation of Consuming Olive Extract on Total Cholesterol Levels
A study testing Polyhpenol extract in people with Metabolic Syndrome | Serum or Plasma | Chemistry - Non-Challenge and Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome | Serum or Plasma | Chemistry - Non-Challenge, Overweight
- What is being tested?
- Polyhpenol extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 3 Apr 2024to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro de Investigacion en Nutricion. Universidad de Navarra
Pamplona, Navarre, 31008
About this study
Official title: 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
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.
- Being tested
- Polyhpenol extract, Placebo
- Keywords
- polyhpenols from olives, metabolic syndrome, cholesterol, lifestyle
- Medical subject headings
- Metabolic Syndrome, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyhpenol extractDietary supplement
Three capsules in fasting conditions 15 minutes prior breakfast
PlaceboDietary supplement
Three capsules in fasting conditions 15 minutes before breakfast
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsules containing placebo. Receives: Dietary Supplement: Placebo |
| Polyhpenol extract | Experimental | Capsules containing the experimental polyhpenol to be assayed Receives: Dietary Supplement: Polyhpenol extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
Serum concentration of Total Cholesterol
Measured: Baseline
Total cholesterol
Serum concentration of Total Cholesterol
Measured: 12 weeks
HDL cholesterol
Serum concentration of HDL cholesterol
Measured: Baseline
HDL cholesterol
Serum concentration of HDL cholesterol
Measured: 12 weeks
LDL cholesterol
Serum Calculated LDL Cholesterol levels
Measured: Baseline
LDL cholesterol
Serum Calculated LDL Cholesterol levels
Measured: 12 weeks
Triglycerides
Serum Triglycerides levels
Measured: Baseline
Triglycerides
Serum Triglycerides levels
Measured: 12 weeks
Secondary outcomes (14)
Weight
Weight status
Measured: Baseline
Weight
Weight status
Measured: 12 weeks
Fat mass
Fat mass in kg, measured by Bioimpedance
Measured: Baseline
Fat mass
Fat mass in kg, measured by Bioimpedance
Measured: 12 weeks
Hemoglobin
Hemoglobin measured as mg/dL
Measured: Baseline
Hemoglobin
Hemoglobin measured as mg/dL
Measured: 12 weeks
Hematocrit
Hematocrit (%)
Measured: Baseline
Hematocrit
Hematocrit (%)
Measured: 12 weeks
Physical Activity
Measured through the IPAQ questionnaire
Measured: Baseline
Physical Activity
Measured through the IPAQ questionnaire
Measured: 12 weeks
Blood pressure
Measured in the dominant arm (mmHg)
Measured: Baseline
Blood pressure
Measured in the dominant arm (mmHg)
Measured: 12 weeks
Dietary intake
FFQ from the SUN Study
Measured: Baseline
Dietary intake
FFQ from the SUN Study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start3 Apr 2024
- Primary completion8 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome | Serum or Plasma | Chemistry - Non-ChallengeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel groups double blind, 12-week nutritional intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490133
- Sponsor's protocol ID
- OLICOL
- Acronym
- OLICOL
- Status last verified
- Sep 2024
- First submitted
- 28 Jun 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06490133
- Acronym / sponsor ID
- OLICOL / OLICOL
- Keywords
- polyhpenols from olives, metabolic syndrome, cholesterol, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 8 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel groups double blind, 12-week nutritional intervention
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsules containing placebo. |
| Polyhpenol extract | Experimental | Dietary Supplement: Polyhpenol extractCapsules containing the experimental polyhpenol to be assayed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyhpenol extractThree capsules in fasting conditions 15 minutes prior breakfast | Dietary supplement | Polyhpenol extract |
| PlaceboThree capsules in fasting conditions 15 minutes before breakfast | Dietary supplement | Placebo |
Primary outcome
Total cholesterol
Time frame: Baseline
Serum concentration of Total Cholesterol
Total cholesterol
Time frame: 12 weeks
Serum concentration of Total Cholesterol
HDL cholesterol
Time frame: Baseline
Serum concentration of HDL cholesterol
HDL cholesterol
Time frame: 12 weeks
Serum concentration of HDL cholesterol
LDL cholesterol
Time frame: Baseline
Serum Calculated LDL Cholesterol levels
LDL cholesterol
Time frame: 12 weeks
Serum Calculated LDL Cholesterol levels
Triglycerides
Time frame: Baseline
Serum Triglycerides levels
Triglycerides
Time frame: 12 weeks
Serum Triglycerides levels
14 secondary outcomes
Weight
Time frame: Baseline
Weight
Time frame: 12 weeks
Fat mass
Time frame: Baseline
Fat mass
Time frame: 12 weeks
Hemoglobin
Time frame: Baseline
Hemoglobin
Time frame: 12 weeks
Hematocrit
Time frame: Baseline
Hematocrit
Time frame: 12 weeks
Physical Activity
Time frame: Baseline
Physical Activity
Time frame: 12 weeks
Blood pressure
Time frame: Baseline
Blood pressure
Time frame: 12 weeks
Dietary intake
Time frame: Baseline
Dietary intake
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyhpenol extract in people with Metabolic Syndrome | Serum or Plasma | Chemistry - Non-Challenge and Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.