NCT04114916

Brief Summary

Randomized parallel and double blind clinical trial in which it is intended to analyze the efficacy of a nutraceutical on cholesterol and endothelial function after the consumption of a product for eight weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
Last Updated

October 3, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

April 19, 2018

Last Update Submit

October 1, 2019

Conditions

Cholesterol

Outcome Measures

Primary Outcomes (7)

  • endothelial function

    Changes in the dilatation of the Humeral artery.

    The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after eight weeks of product consumption.

  • blood samples

    Change in total cholesterol levels.

    Total cholesterol measurements are taken with the ILAB 600 analyzer on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.

  • Tests

    Change in physical activity with the World Physical Activity Questionnaire (GPAQ)

    Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.

  • nutritional record

    Volunteers record dietary intake for three days in a notebook. They will describe the amount of food they consume in grams in order to assess changes in intake during the clinical trial.

    The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.

  • body composition

    Changes in body composition were measured with a TANITA

    Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.

  • cardiovascular risk

    Changes in systolic blood pressure (mmHg), dystolic blood pressure (mmHg) and heart rate (beats per minute).

    Cardiovascular risk measurements are taken by laboratory analysis on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.

  • Tests

    Change in the quality of life (SF-12).

    Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.

Study Arms (2)

Apigenin, luteonin, grapefruit extract and citrolive

EXPERIMENTAL

One capsules a day. It will be consumed at breakfast for eight weeks.

Dietary Supplement: Apigenin, luteonin, grapefruit extract and citrolive

maltodextrina

PLACEBO COMPARATOR

One capsules a day. It will be consumed at breakfast for eight weeks.

Dietary Supplement: maltodextrina

Interventions

Apigenin, luteonin, grapefruit extract and citroliveDIETARY_SUPPLEMENT

Two capsules daily at breakfast and dinner.

Apigenin, luteonin, grapefruit extract and citrolive
maltodextrinaDIETARY_SUPPLEMENT

Two capsules daily at breakfast and dinner.

maltodextrina

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects of both sexes (men or women) between 40 and 75 years of age, of Caucasian race
  • Women must be in the menopausal period.
  • Present body mass index between 18.5 and 34.9 Kg / m2.
  • The number of platelets in whole blood must be greater than 170 x109 / L
  • Hematocrit greater than 40% for men or greater than 35% for women.
  • Hemoglobin greater than 120 g / L for men or 110 g / L for women.
  • Present fasting levels of LDL-serum cholesterol equal to or greater than 110mg / dL
  • Present fasting values of total serum cholesterol equal or superior to 180mg / dL
  • Volunteers able to understand the clinical study and willing to give written informed consent and to comply with the procedures and requirements of the study.

You may not qualify if:

  • Thyroid dysfunction, infections, or with any type of chronic disease (for example, autoimmune, inflammatory).
  • Subjects who have suffered an ischemic-vascular event during the last months
  • Subjects undergoing medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (eg Statins).
  • Subjects under treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...)
  • Subjects under treatment that affect body weight or appetite.
  • History of allergic hypersensitivity or poor tolerance to any component of the products under study.
  • Subjects who are performing or intend to perform any type of diet, hypocaloric or not, during the conduct of the study.
  • Subjects who have donated a minimum of 0.5L of blood in the last month.
  • Vegetarian subjects.
  • Subjects, who have ingested, in the last three months, supplements of omega 3 and / or 6, (eg fish oil, evening primrose oil, krill oil, or algae oil).
  • Subjects under treatment with niacin or fibrates.
  • Those subjects with alcohol abuse, or with excessive alcohol consumption (\> 3 glasses of wine or beer / day) will be excluded.
  • Patients undergoing major surgery in the last 3 months.
  • Subjects who smoke or not, but in any case who do not modify their nicotinic habits during their participation in the study.
  • Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Apigeningrapefruit seed extract

Intervention Hierarchy (Ancestors)

FlavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2018

First Posted

October 3, 2019

Study Start

October 1, 2016

Primary Completion

December 22, 2018

Study Completion

December 30, 2018

Last Updated

October 3, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

ES(1)