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.

BACKGROUND: 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. METHODS: 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). RESULTS: 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). CONCLUSION: 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 REGISTRATION: Trial retrospectively registred on ClinicalTrial.gov under ID: NCT03545399 Date: 05/22/2018.

Evaluation of the antidepressant- and anxiolytic-like effects of a hydrophilic extract from the green seaweed Ulva sp. in rats.

OBJECTIVES: The green seaweed Ulva sp. contains a large amount of ulvans, a family of sulphated polysaccharides. The present study was designed to investigate in rats the antidepressant- and anxiolytic-like effects of a hydrophilic extract of Ulva sp. (MSP) containing about 45% of ulvans. METHODS: After a 14-day administration of MSP at doses of 10, 20 and 40 mg/kg/day, 48 and 60 male adult Wistar rats were respectively tested in the elevated plus-maze (EPM) and the forced swimming test (FST). In the FST, MSP effects were compared to the reference antidepressant drug imipramine (IMI) (10 mg/kg/day). Acute and sub-chronic toxicities of the extract were also assessed in male and female rats following OECD guidelines. RESULTS: MSP treatment did not modify anxiety-related behaviour in the EPM. In contrast, MSP induced a dose-dependent reduction of immobility behaviour in the FST. At the highest tested dose of 40 mg/kg, MSP displayed a significant antidepressant-like effect similar to IMI. MSP did not modify the exploratory behaviour of rats in the open field test and did not produce any toxic effect. DISCUSSION: MSP may potentially represent a good adjunct or alternative to existing antidepressant therapeutics. Further studies are necessary to confirm the mechanism of action of MSP and its modulation of brain functioning.