NCT03510221

Brief Summary

Recent evidence suggests that there is a directly proportional relationship between diets with a high concentration of antioxidants and the reduction of blood pressure and the risk of cardiovascular events. However, there is a gap with regard to research on the effects of these diets on vascular function, especially in humans. The aim of this study was to evaluate the effect of antioxidant supplementation through the consumption of blueberry, cranberry and pomegranate extract capsules (1 of each per day), the effect of the autonomic balance in hypertensive and normotensive adults.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable hypertension

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

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
Last Updated

April 27, 2018

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

March 29, 2018

Last Update Submit

April 25, 2018

Conditions

HypertensionOxidative StressAutonomic ImbalanceInsulin Resistance

Keywords

HypertensionOxidative stressAntioxidantAutonomic imbalanceInsulin resistanceCytokines

Outcome Measures

Primary Outcomes (1)

  • Effect of antioxidants on heart rate variability in 29 normotensive subjects and 30 hypertensive patients

    Antioxidant supplementation should improve heart rate variability as a consequence of improved antioxidant capacity

    4 weeks

Secondary Outcomes (3)

  • Effect of antioxidants on insulin resistance in 29 normotensive subjects and 30 hypertensive patients

    4 weeks

  • Effect of antioxidants on blood pressure in 29 normotensive subjects and 30 hypertensive patients

    4 weeks

  • Effect of antioxidants on antioxidant capacity in 29 normotensive subjects and 30 hypertensive patients

    4 weeks

Study Arms (2)

Antioxidants

ACTIVE COMPARATOR

Subjects received 3 antioxidant capsules (1 capsule of blueberry + 1 capsule of cranberry + 1 capsule pomegranate - a day) during 4 weeks.

Dietary Supplement: Antioxidants capsules

Placebo

PLACEBO COMPARATOR

Subjects received 3 placebo capsules during 4 weeks.

Dietary Supplement: Antioxidants capsules

Interventions

Antioxidants capsulesDIETARY_SUPPLEMENT

1 capsule of cranberry, 1 capsule of blueberry, and 1 capsule of pomegranate extracts were offered during 4 weeks

AntioxidantsPlacebo

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of hypertension - group Hypertensives
  • Healthy people - group Normotensive

You may not qualify if:

  • Patients with glycated hemoglobin \> 7%,
  • Patients with a diagnosis of cardiovascular disease,
  • Patients with LDL-cholesterol\> 160 mg/dL (non-diabetics)
  • Pregnant women,
  • Cigarret smokers,
  • Diabetics using more than one drug in addition to metformin,
  • Patients with LDL-cholesterol\> 130 mg/dL (non-diabetic using statin),
  • LDL cholesterol ≥ 100 mg / dL (patients on statin),
  • Patients with valvular heart disease,
  • Pulmonary hypertension,
  • Patients with collagen disease,
  • Patients with type of cancer,
  • Complex arrhythmia,
  • Those patients with any chronic crippling pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionInsulin Resistance

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A group of hypertensive patients and a group of normotensive individuals
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 27, 2018

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 27, 2018

Record last verified: 2016-01