NCT02637570

Brief Summary

This study evaluated effect of Hibiscus tea and green tea supplements on athletic performance, blood pressure, muscle damage indices and oxidative stress in male athletes 18-35 years old and cardiovascular disease prevention approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

October 19, 2015

Last Update Submit

August 9, 2017

Conditions

Healthy

Keywords

healthy male athletes18-35 years old

Outcome Measures

Primary Outcomes (4)

  • athletic performance assess by heart rate in step test (Harvard test).

    6 weeks

  • blood pressure

    6 weeks

  • serum's malondialdehyde

    it will asses by spectrophotometry.

    6 weeks

  • serum's lactate dehydrogenase

    it will asses by calorimetry.

    6 weeks

Study Arms (3)

Hibiscus tea

EXPERIMENTAL

420 mg Hibiscus 2 hour after dinner with 1 glass of cool water every day

Dietary Supplement: Hibiscus teaDietary Supplement: placebo (dextrose)

green tea

EXPERIMENTAL

450 mg green tea 2 hour after dinner with 1 glass of cool water every day

Dietary Supplement: green teaDietary Supplement: placebo (dextrose)

control group

PLACEBO COMPARATOR

450 mg placebo (dextrose) 2 hour after dinner with 1 glass of cool water every day

Dietary Supplement: Hibiscus teaDietary Supplement: green tea

Interventions

Hibiscus teaDIETARY_SUPPLEMENT
Hibiscus teacontrol group
green teaDIETARY_SUPPLEMENT
control groupgreen tea
placebo (dextrose)DIETARY_SUPPLEMENT
Hibiscus teagreen tea

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 to 35 y/o
  • no history of smoking or alcohol consumption
  • no taking nutritional sport supplements during the last 2 months

You may not qualify if:

  • any injury during intervention
  • any inflammatory disease during the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

male sports club members of Isfahan university of medical sciences

Isfahan, Iran

Location

MeSH Terms

Interventions

TeaGlucose

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Student, Food Security Research Center, Department of Community nutrition, School of Nutrition & Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran

Study Record Dates

First Submitted

October 19, 2015

First Posted

December 22, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 11, 2017

Record last verified: 2017-08

Locations

IR(1)