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

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.

Study Overview

• Status: Completed
• Conditions: Mood Modulation; Modulation of Cognition
• Intervention / Treatment: Dietary supplement: Hops Extract; Other: Placebo (silica)

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE1 8ST
    • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood	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.	across 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety	Satiety as assessed by VAS (hungry/full/desire to eat/food intake).; The modulation of satiety (VAS) inculcated by completion of the cognitive tasks.	across 3 hours
Bioavailability of Hops	• Plasma hops levels are to be examined to assess bioavailability.	across 3 hours
Cognition	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.	across 3 hours

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: The New Zealand Institute for Plant and Food Research

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (ESTIMATE): June 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 25, 2012
• Last Update Submitted That Met QC Criteria: June 22, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Bioavailability; Blood Pressure; Satiety; Cognitive Function; Mood; Heart rate; Hops
• Other Study ID Numbers: 21AO1