Sub-chronic Effects of 5-hydroxytryptophan on Mood and Emotional Processing in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northumbria University
ClinicalTrials.gov Identifier:
NCT01514409
First received: January 17, 2012
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

5-hydroxytryptophan (5-HTP) is a nutritional supplement sold in many health food stores, and is taken in order to raise levels of serotonin in the brain. Serotonin is a neurotransmitter that is involved in the regulation of mood.

Previous research has assessed the effects of raising serotonin levels using tryptophan (the precursor of 5-HTP) and serotonergic antidepressants on emotional processing in healthy volunteers. However, to date there has been no human trial investigating the effects of 5-HTP on emotional processing in healthy volunteers.

Thus, the current study aims to assess the effects of 5-HTP, on emotional processing and mood in healthy volunteers.


Condition Intervention
Mood
Dietary Supplement: 5-Hydroxytryptophan
Dietary Supplement: Pharmaceutical grade silica

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sub-chronic Effects of 5-hydroxytryptophan on Mood and Emotional Processing in Healthy Volunteers: A Randomised Trial

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The BDI-II is a measure used to assess the severity of depressive symptoms. It is comprised of 21 items that are scored on a scale ranging from 0-3, with total scores ranging from 0-63. Scores of over 16 are indicative of depressive symptoms.

  • Profile of Mood States-Bipolar (POMS-BI) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The POMS-BI is a measure used to assess subjective mood. It comprises 72 adjectives which describe mood states. Participants indicate how well the adjectives describe how they feel on a four point scale ranging from 0-3. The POMS-BI measures the following six bipolar mood states: composed-anxious, elated-depressed, agreeable-hostile, clearheaded-confused, energetic-tired, and confident-unsure.

  • Emotional Perception: Facial Expression Recognition Task [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Participants are shown faces displaying five different emotions - happiness, sadness, fear, anger, and disgust. Each facial expression has been morphed between 0% (neutral) to 100% in 25% increments. Four examples of each emotion at each intensity are displayed on a computer screen (84 stimuli presentations in total). Faces are displayed for 500ms aand then replaced with a blank screen. Participants have to indicate what facial expression has been displayed by clicking the corresponding button on-screen with the mouse. Accuracy, reaction times, and misclassifications are measured.

  • Emotional Categorisation and Memory [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Participants are shown sixty personality characteristics consecutively (30 agreeable, 30 disagreeable)on a computer screen in random order for 500ms each. Participants are asked to judge whether the personality traits are 'likeable' or 'dislikeable'. Classifications and reaction times for correct choices are recorded. Participants are then asked to recall as many personality characteristics as they can in order to assess their incidental memory for positive versus negative material.

  • Emotional Attention: Attentional Probe Task [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The attentional probe task based on MacLeod, Matthews and Tata's (1986) visual attention paradigm is used to assess participants attention towards positive versus negatively valenced words. Accuracy and reaction time is recorded.


Enrollment: 33
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-Hydroxytryptophan Dietary Supplement: 5-Hydroxytryptophan

Thirty-three participants were randomly allocated in a double-blind manner to receive either 3x50mg capsules of 5-HTP or placebo (silica) for 14 days.

5-HTP is produced commercially by extraction from the seeds of the African plant griffonia simplicifolia.

Placebo Comparator: Placebo Dietary Supplement: Pharmaceutical grade silica
Pharmaceutical grade silica was utilized as placebo

Detailed Description:

The serotonin precursor 5-HTP is sold as a nutritional supplement and has been used to offset low mood for over 30 years due to its ability to raise levels of neural serotonin. However, evidence for the efficiency of 5-HTP is limited and the mechanism of action of 5-HTP in offsetting low mood has not been well-characterised.

The current study assessed the ability of 5-HTP to induce biases for positive emotional material in healthy volunteers, similar to those induced by serotonergic antidepressants and the nutritional supplement tryptophan. The effects of 5-HTP on subjective mood and depressive symptoms were also assessed.

Participants were randomised to receive either 150mg of 5-HTP or placebo daily for 14 days. Depressive symptoms and subjective mood were assessed pre- and post-intervention. Emotional processing was assessed on the 15th day using a battery of emotionally valenced cognitive tasks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male/Female
  • Healthy
  • Aged 18-65
  • Not taking any herbal or prescription medications (excluding contraceptive pill)
  • Free from depressive illness or mood disorder for the last 6 months
  • Free of physical illness

Exclusion Criteria:

  • Physically ill
  • History of medical illness
  • Current or previous (6 month) history of psychiatric disorder
  • Pregnant/breastfeeding
  • Allergy or hypersensitivity to any of the ingredients contained in the investigational product
  • Taking any medication (excluding contraceptive pill)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514409

Locations
United Kingdom
Northumbria University
Newcastle Upon Tyne, United Kingdom
Sponsors and Collaborators
Northumbria University
  More Information

No publications provided

Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT01514409     History of Changes
Other Study ID Numbers: 24AQ1
Study First Received: January 17, 2012
Last Updated: January 20, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
5-hydroxytryptophan
Mood
Emotional Processing
Emotional Cognition
Nutritional Supplement
Low mood

Additional relevant MeSH terms:
5-Hydroxytryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014