NCT02578927

Brief Summary

The objective is to investigate whether the ingestion of green tea prior to physical exercise improvement post-exercise hypotension (PEH). Double-blind, randomized, placebo study. Fifteen hypertensive (53±4.5 years) performed three procedures: green tea+exercise (GT+Ex), placebo+exercise (PL+Ex), green tea without exercise (GT). Thirty minutes after ingesting 2g of green tea or placebo, they performed treadmill walking (60 minutes), 60 to 85% of maximum heart rate intensity in procedures with exercises. BP was measured at rest and at every 10 minutes after exercise (60 minutes). Blood samples were taken before the ingestion of green tea or placebo and immediately after exercise to determine Malondialdehyde (MDA) and Nitrite (NO) dosages. Reduction of systolic BP compared with the rest, during PL+Ex recovery procedure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2013

Typical duration 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, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

September 11, 2015

Last Update Submit

October 16, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    The sessions of exercise were released with interval of 30 days between them, thus each volunteer devoted an average 40 days to the study.

    Change from baseline Bood Pressure at 60 minutes post exercise in the same experimental session

Study Arms (3)

GT+Ex

EXPERIMENTAL

Ingestion of one dose of 2 g of green tea (GT) ingested at 10 minutes after the period of rest. After the Ingestion, the volunteers practice aerobic exercise (EX) in treadmill.

Dietary Supplement: GT+Ex

PL+Ex

PLACEBO COMPARATOR

Ingestion of one dose 2 g of placebo (PL) ingested at 10 minutes after the period of rest. After the Ingestion, the volunteers practice aerobic exercise (EX) in treadmill.

Dietary Supplement: PL+Ex

Green Tea

ACTIVE COMPARATOR

Ingestion of one dose 2g of green tea (GT) at 10 minutes after the period of rest. In this section the volunteers does not practice aerobic exercise.

Dietary Supplement: Green Tea

Interventions

GT+ExDIETARY_SUPPLEMENT

In this session the volunteers ingested capsules with 2g of powder green tea before exercise

GT+Ex
PL+ExDIETARY_SUPPLEMENT

In this session the volunteers ingested capsules with 2g of placebo before exercise

PL+Ex
Green TeaDIETARY_SUPPLEMENT

In this investigation the volunteers ingested capsules with 2g of powder green tea before the rest similar to the exercise time

Green Tea

Eligibility Criteria

Age40 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hypertensive
  • Physically active for at least 3 months
  • Not diabetics individuals.

You may not qualify if:

  • Modifying the therapeutic treatment during the study
  • Use beta-blocker drugs, and calcium channel blockers
  • Menopausal women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Tea

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Manoel Miranda Neto, graduation

    Federal University of Paraíba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate

Study Record Dates

First Submitted

September 11, 2015

First Posted

October 19, 2015

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 19, 2015

Record last verified: 2015-10