NCT02628353

Brief Summary

The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic BP after ingestion of a high fat meal.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

December 3, 2015

Last Update Submit

January 31, 2017

Conditions

Cardiovascular Risk FactorsBlood Pressure

Keywords

Cardiovascular diseasesendothelial functionsystolic blood pressuremetabolomicscardiovascular risk factorbioavailabilityphenolic compoundshypertension

Outcome Measures

Primary Outcomes (1)

  • Change of Systolic Blood Pressure

    During each visit (2 visits in total), systolic BP will be measured after 10 min in a seated position in a comfortable room by the physician. The measurement will be taken in triplicate at 1-min intervals using an automatic sphygmomanometer (OMRON HEM-907; PEROXFARMA, Barcelona, Spain). The first measurement will be discarded and the final result will be the average of the other measurements.. The research team will mesure the change in the evolution of systolic blood pressure between visits (at least 1 week between visits).

    In each visit (2 visits in total), systolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement.

Secondary Outcomes (4)

  • Diastolic Blood Pressure

    In each visit (2 visits in total), diastolic blood pressure will be measured at baseline (0 min) and 60, 120, 180, 240, 300 and 360 minutes after the ingestion of a fat load and the supplement.

  • Ischemic reactive hyperemia (IRH)

    In each visit (2 visits in total), at 0, 120, 240 and 360 minutes

  • Bioavailability of phenolic compound in plasma samples

    In each visit (2 visits in total), at 0, 60, 120, 180, 240, 300 and 360 minutes (heparin lithium plasma)

  • Bioavailability of phenolic compound in urine

    In each visit (2 visits in total), at 0, 180 and 360 minutes (total urine)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

control group

Dietary Supplement: placebo

Phenolic compound

EXPERIMENTAL

treated group

Dietary Supplement: phenolic compound

Interventions

placeboDIETARY_SUPPLEMENT

1 capsule of placebo product (100 mg carboxymetylcellulose) in one visit

Placebo
phenolic compoundDIETARY_SUPPLEMENT

1 capsule of phenolic compound product (100mg phenolic compound + 100 mg carboxymetylcellulose) in one visit

Phenolic compound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults men or women (\>18 years old)
  • Blood pressure (with no drug intervention) ≥130 mm Hg systolic blood pressure ≤ 159 mmHg
  • No evidence of chronic disease
  • Written informed consent provided before the initial screening visit.

You may not qualify if:

  • Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≥100 mm Hg or taking antihypertensive medication
  • Body mass index (BMI) ≥ 35 kg/m2
  • Glucose (fasting state) \>125 mg/dL
  • LDL-cholesterol \>189 mg/dL
  • Triglycerides \>350 mg/dL
  • Pregnant or intending to become pregnant
  • Use of medication, antioxidant, or multi-vitamin supplements
  • Chronic alcoholism
  • Intense physical activity (5h/week)
  • Intestinal disorders
  • Following of a vegetarian diet
  • Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
  • Being intolerant or suffer from allergy to any of the products of the high fat meal (white bread, olive oil, boiled egg, cheese) or to the products of the study.
  • Failure to follow the study guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technological Centre of Nutrition and Health (CTNS)

Reus, Tarragona, 43204, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesHypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Rosa Solà, PhD

    University Rovira i Virgili / Hospital Universitari Sant Joan de Reus

    PRINCIPAL INVESTIGATOR

  • Begoña Muguerza, PhD

    University Rovira i Virgili

    STUDY CHAIR

Central Study Contacts

Rosa Maria Valls, PhD

CONTACT

+34977759377/636944723estudis@ctns.cat

Anna Pedret, PhD

CONTACT

+34977759377/636944723estudis@ctns.cat

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 11, 2015

Study Start

December 1, 2015

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

ES(1)