## Protocol Section
### Identification Module
**NCT ID:** NCT01421979

**Brief Title:** Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans

#### Organization Study ID Info
**ID:** ED2011
#### Organization
**Class:** OTHER
**Full Name:** University of Hohenheim
### Status Module
#### Completion Date
**Date:** 2013-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-02-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-02-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-08

**Type:** ACTUAL

#### Start Date
**Date:** 2011-04

**Status Verified Date:** 2015-02

#### Study First Post Date
**Date:** 2011-08-23
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-22
**Study First Submit QC Date:** 2011-08-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Hohenheim

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health.

### Conditions Module

**Conditions:**

- Cardiovascular Risk

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 38

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Examination of the effects of EDs in combination with alcohol consumption and sleep deprivation.

**Intervention Names:**

- Dietary Supplement: Energy Drink, Taurine, Caffeine

**Label:** exposure under sleep deprivation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Examination of the effects of EDs in combination with alcohol consumption and exercise.

**Intervention Names:**

- Dietary Supplement: Energy Drink, Taurine, Caffeine

**Label:** Exercise after consumption

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exercise after consumption

- exposure under sleep deprivation

**Name:** Energy Drink, Taurine, Caffeine

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Measure:** Heart-rate-variability (HRV)

**Time Frame:** during 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* written informed consent
* healthy (no acute or chronic desease)
* BMI 20,0 - 25,9 kg/m2
* moderate and non-regular consumption of alcohol, EDs and coffee

Exclusion Criteria:

* pregnancy
* regular medication (oral contraceptives permitted)
* hypertension and other deseases of the cardiovascular system
* liver-deseases
* psychiatric deseases
* epilepsy
* other relevant deseases
* (former) alcoholics
* non-compliance to the study-protocol
* simultaneous participation in another clinical trial
* retraction of the written informed consent

**Healthy Volunteers:** True

**Maximum Age:** 25 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stuttgart

**Country:** Germany

**Facility:** University of Hohenheim

**State:** Baden-Württemberg

**Zip:** 70593

### References Module

#### References

**Citation:** Basrai M, Schweinlin A, Menzel J, Mielke H, Weikert C, Dusemund B, Putze K, Watzl B, Lampen A, Bischoff SC. Energy Drinks Induce Acute Cardiovascular and Metabolic Changes Pointing to Potential Risks for Young Adults: A Randomized Controlled Trial. J Nutr. 2019 Mar 1;149(3):441-450. doi: 10.1093/jn/nxy303.

**PMID:** 30805607

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000697

- Term: Central Nervous System Stimulants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000010726

- Term: Phosphodiesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000058915

- Term: Purinergic P1 Receptor Antagonists

- ID: D000058914

- Term: Purinergic Antagonists

- ID: D000058905

- Term: Purinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M5373

- Name: Caffeine

- Relevance: HIGH

- As Found: Sterile

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

- ID: M13629

- Name: Phosphodiesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: T370

- Name: Caffeine

- Relevance: HIGH

- As Found: Sterile

- ID: T19

- Name: Taurine

- Relevance: HIGH

- As Found: Sciatic nerve block

### Intervention Browse Module - Meshes

- ID: D000002110

- Term: Caffeine

### Misc Info Module

- Version Holder: 2024-05-24
