The Effect of an Edible Algal Extract (Ulva Lactuca) on the Component of Depression in Healthy Volunteers With Anhedonia

NCT03545399 | Completed

• 1 other identifier: C1365
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The effects of the seaweed extract were evaluated on the animal model equivalent of depression compared with a control group treated with the carrier (spring water) and a reference group treated with Imipramine and showed significative effect. This clinical trial was intended to confirm in humans the potential efficacy identified in animals. The primary objective was to compare against a placebo the effect of Ulva L.L extract in healthy volunteers whose anhedonia was characterized by a component of depression.

Conditions

Anhedonia in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Evolution of anhedonia in healthy subjects

  The evolution of anhedonia in healthy subjects whose anhedonia was characterized by a component of depression was measured by the Snaith-Hamilton Pleasure Scale (SHAPS).The SHAPS questionnaire is composed of 14 questions, the total score of the SHAPS varies between 0 and 14. Severe anhedonia will be observed if the SHAPS score is strictly greater than 5.

  84 days

Secondary Outcomes (6)

• Evolution of the subject's mood

  84 days

• The effect on work and other activities

  84 days

• Evolution of the components of depression

  84 days

• Evaluation of subject's satisfaction

  84 days

• Evaluation of product's tolerance

  84 days

Study Arms (2)

Ulva Lactuca

EXPERIMENTAL

The subject is given a capsule containing a concentrated fraction of freeze-dried and crushed hydrosoluble extract of seaweeds. The dose tested of extract of seaweeds is of 6.45mg per kg weight. The daily dose is 3 capsules per day for subjects weighing between 50 and 70kg, 4 capsules per day for subjects weighing between 70 and 90kg and 5 capsules per day for subjects weighing between 90 and 110kg. The duration of the treatment is 12 weeks.

Dietary Supplement: Ulva Lactuca

Placebo

PLACEBO COMPARATOR

The subject is given a capsule looking alike that of the active product but containing no extract of seaweeds.The duration of the treatment is 12 weeks.

Dietary Supplement: Placebo

Interventions

Ulva Lactuca DIETARY_SUPPLEMENT

The dose was taken with a glass of water during the evening meal once daily

Ulva Lactuca

Placebo DIETARY_SUPPLEMENT

The dose was taken with a glass of water during the evening meal once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged between 18 and 65 years
• Presenting a anhedonia with a score ≥5 on the SHAPS Scale
• Declaring feeling low for at least 4 weeks characterised by a component of depression evaluated on the QIDS-SR
• Being able to apprehend and fill in the evaluation scales

You may not qualify if:

• Subject with a major depressive episode as per the DSM V scale, with a HAM D \> 8, already on anxiolytic, antidepressor, neuroleptic or any other medicinal treatment liable to influence mood (e.g. benzodiazepines) in the last 30 days or using illegal psychotropic substances, or a with daily alcohol intake of more than three glasses of wine
• Presenting a psychiatric disorder or in state of post-traumatic stress or having had an electroconvulsive therapy in the last 6 months
• Female subject pregnant or breast-feeding or of childbearing age and not using effective means of contraception
• subject suffering from an allergy or intolerance to seafood products (fish, shellfish and seaweed)

Sponsors & Collaborators

• CEN Biotech: lead
• CEN Nutriment: collaborator
• Biovet Conseil: collaborator
• Amadeite SAS: collaborator

Related Publications (1)

• Allaert FA, Demais H, Collen PN. A randomized controlled double-blind clinical trial comparing versus placebo the effect of an edible algal extract (Ulva Lactuca) on the component of depression in healthy volunteers with anhedonia. BMC Psychiatry. 2018 Jun 28;18(1):215. doi: 10.1186/s12888-018-1784-x.

  PMID: 29954354 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-centre double-blind randomized placebo-controlled clinical trial on parallel arms of two groups of 45 subjects

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: June 4, 2018
• Study Start: June 29, 2015
• Primary Completion: May 31, 2016
• Study Completion: May 31, 2016
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share