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.

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.

Anhedonia in Healthy Volunteers

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

Ulva Lactuca

Placebo

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

Essai Clinique randomisé en Double Aveugle Contre Placebo de l'évaluation de l'Effet d'un Extrait d'Algues Comestibles (Ulva Lactuca) Chez Des Volontaires Sains présentant Une anhédonie associée à Une Baisse de Moral

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.

Evolution of the mood of subjects measured by the Brief Mood Introspection Scale (BMIS).Each "positive" item (Dynamic, Happy, Compassionate, Content, Energetic, Quiet, Affectionate and Vivid) is rated from 1 "Not at all" to 4 "Absolutely". Each item "negative" (Sad, Tired, Melancholic, Excited, Exhausted, Grumpy, Nervous and Annoyed) is inversely rated from 1 "quite" to 4 "not at all". The BMIS questionnaire is composed of 16 questions, and will be calculated by adding the answers of these 16 items. The BMIS score varies between 16 and 64.

The effect on work and other activities according to item 7 of the Hamilton Rating Scale for Depression (HAM-D).The HAM-D is a scale for depression composed of 17 questions and varies between 0 and 58.
The HAM-D score will also be classified into 5 classes according to the following model:
0-7 None; 8-13 Light; 14-18 Moderate; 19-22 Severe; > 23 Very severe

Evolution of the components of depression is measured by the Quick Inventory of Depressive Symptomatology -Self-Report (QIDS-SR).QIDS-SR questionnaire is composed of 16 questions. Each answer is scored from 0 to 3. The symptomatology is more important with a higher score. The total score fluctuates between 0 and 27.
The QIDS score will also be classified into 5 classes according to the following model:
0-5 None; 6-10 Lightweight; 11-15 Moderate; 16-20 Severe; > 20 Very severe

Subject's satisfaction with the treatment was evaluated by the Patient Global Improvement Impression (PGII)

The evaluation of product's tolerance for the whole period of the trial is done by the reporting of Serious Adverse Event if any

Evaluation of the investigator's opinion is measured by the Clinical Global Improvement Impression (CGII)

CEN Biotech

CEN Nutriment

Biovet Conseil

Amadeite SAS

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

lactuca orientalis/antidepresan

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

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