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

Not Applicable

Completed

• Conditions: Mood Modulation; Modulation of Cognition
• Interventions: Dietary Supplement: Hops Extract; Other: Placebo (silica)

• Registration Number: NCT01376869
• Lead Sponsor: Northumbria University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-20
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
410mg extract 1 hops	Hops Extract	Equivalent to 2g dry weight
79mg extract 2 hops	Hops Extract	Equivalent to 0.5g dry weight
316mg extract 2 hops	Hops Extract	Equivalent to 2g dry weight
102mg extract 1 hops	Hops Extract	Equivalent to 0.5g dry weight
Placebo	Placebo (silica)	-

Primary Outcome Measures

Name	Time	Method
Mood	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

Name	Time	Method
Satiety	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.
Bioavailability of Hops	across 3 hours	• Plasma hops levels are to be examined to assess bioavailability.
Cognition	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.

Trial Locations

Locations (1)

Northumbria University; 🇬🇧 Newcastle upon Tyne, United Kingdom