Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants

• ClinicalTrials.gov Identifier: NCT01376869
• Recruitment Status: Completed
• First Posted: June 20, 2011
• Last Update Posted: June 25, 2012
• Sponsor: Northumbria University
• Collaborator: The New Zealand Institute for Plant and Food Research
• Information provided by (Responsible Party): Crystal Haskell, Northumbria University

Study Description

Brief Summary:

Hops have been used for many years for their supposed sedative and anxiety reducing properties and can be found in many natural remedies for stress, anxiety and sleeping that are already available to buy.

However, human trials investigating the effects of hops have so far been limited to the effects of the combination of hops and valerian in relation to sleep. Such studies have identified that a valerian-hops mixture can result in improved sleep but Valerian alone has no effect.

The current study aims to investigate the effect of hops alone in healthy human participants aged 18-35 years.

Condition or disease	Intervention/treatment	Phase
Mood Modulation; Modulation of Cognition	Dietary Supplement: Hops Extract; Other: Placebo (silica)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
• Study Start Date: June 2011
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 102mg extract 1 hops; Equivalent to 0.5g dry weight	Dietary Supplement: Hops Extract; All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers will be used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.
Active Comparator: 410mg extract 1 hops; Equivalent to 2g dry weight	Dietary Supplement: Hops Extract; All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers will be used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.
Active Comparator: 79mg extract 2 hops; Equivalent to 0.5g dry weight	Dietary Supplement: Hops Extract; All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers will be used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.
Active Comparator: 316mg extract 2 hops; Equivalent to 2g dry weight	Dietary Supplement: Hops Extract; All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers will be used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.
Placebo Comparator: Placebo	Other: Placebo (silica); All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers were used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.

Outcome Measures

Primary Outcome Measures :

1. Mood [ Time Frame: across 3 hours ]
   • Mood as assessed by STAI, Bond-Lader mood scales, POMS, DEQ and stress/euphoria/sedation visual analogue scales (VAS).
   • The shift in mood (STAI, Bond-Lader, POMS, DEQ, Stress/Euphoria/Sedation VAS) inculcated by completion of cognitive tasks.
   • Heart rate and blood pressure.
   • The modulation of blood pressure and heart rate inculcated by completion of cognitive tasks.

Secondary Outcome Measures :

1. Satiety [ Time Frame: across 3 hours ]
   • Satiety as assessed by VAS (hungry/full/desire to eat/food intake).
   • The modulation of satiety (VAS) inculcated by completion of the cognitive tasks.
2. Bioavailability of Hops [ Time Frame: across 3 hours ]
   • Plasma hops levels are to be examined to assess bioavailability.
3. Cognition [ Time Frame: across 3 hours ]
   • Performance on working memory tasks (2-back and logical reasoning).
   • Performance on serial subtraction element of a dual task.
   • Performance on word and picture recognition tasks.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Male/female,
• Healthy
• Age 18-35 years old
• Non smoker
• Proficient in English
• Not taking any herbal or prescription medications
• Not pregnant seeking to become pregnant or breastfeeding

Exclusion Criteria:

• Allergy or hypersensitivity to any of the ingredients contained in the investigational product or any other foodstuff.
• Vegetarian (as the capsules contain gelatine).
• Have a history of neurological, vascular or psychiatric illness (including depressive illness and anxiety).
• Have a current/ history of drug or alcohol abuse.
• Currently take medication (excluding the contraceptive pill).
• High Blood Pressure (>140/90)
• BMI outside of the range 18- 34.9

Contacts and Locations

Locations

United Kingdom

Northumbria University

Newcastle upon Tyne, United Kingdom, NE1 8ST

Sponsors and Collaborators

Northumbria University

The New Zealand Institute for Plant and Food Research

Investigators

• Study Director: Crystal Haskell; Northumbria University

More Information

• Responsible Party: Crystal Haskell, Research Fellow, Northumbria University
• ClinicalTrials.gov Identifier: NCT01376869 History of Changes
• Other Study ID Numbers: 21AO1
• First Posted: June 20, 2011
• Last Update Posted: June 25, 2012
• Last Verified: June 2012

Keywords provided by Crystal Haskell, Northumbria University:

Hops; Mood; Cognitive Function; Bioavailability; Satiety; Blood Pressure; Heart rate

Additional relevant MeSH terms:

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs