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

摘要

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. Single-centre double-blind randomized placebo-controlled clinical trial on parallel arms of two groups of 45 subjects. The study could include men or women aged 18 to 65?years with anhedonia characterized by a Snaith Hamilton Pleasure Scale score (SHAPS) of ≥5 and feeling low morale for at least four weeks characterized by a component of depression evaluated on the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR). Evaluation criteria: QIDS-SR; Patient Global Improvement Impression (PGII) and Clinical Global Improvement Impression (CGII). 86 subjects were included in the trial: 42 in the placebo group and 44 Ulva group. At D84, QIDS-SR significantly decreased more in the Ulva.L.L. group than in the placebo group (p: 0.0389). This difference is essentially linked to an improvement of the sleep disorders (p: 0.0219), of the psychomotor consequences (p: 0.002) and of the nutrition behaviour (p: 0.0694). 90.1% have the feeling of being improved in the Ulva group vs 72.5% in the placebo group (p: 0.0114) and in parallel 90.9% of the practitioners have the feeling that the subject has improved vs 70.8% (p: 0.0214). This double-blind randomized placebo-controlled trial shows that daily intake for three months of a water-soluble extract of Ulva L.L. continues to significantly improve the component of depression of subjects presenting anhedonia compared with a placebo. Trial retrospectively registred on ClinicalTrial.gov under ID: NCT03545399 Date: 05/22/2018.