CEN Experimental
Dijon, 21000, France
NCT Number: NCT05306093
The aim of this study is to evaluate the effect of nutraceutical supplement on depressed mood and anhedonia in volunteers after 8 weeks of consumption.
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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Dijon, 21000, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Food supplements are consumed during 8 weeks by healthy volunteers
Food supplements are consumed during 8 weeks by healthy volunteers
Time frame: Baseline (V1)
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Time frame: at 2 weeks
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Time frame: at 4 weeks (V2)
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Time frame: at 6 weeks
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Time frame: at 8 weeks (V3)
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Time frame: Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion.
Time frame: Baseline (V1) and each evaluation (at 1 week, 2 weeks, 3 weeks, 4 weeks (V2), 5 weeks, 6 weeks, 7 weeks and the end of the study : 8 weeks (V3))
This validated self-reported questionnaire measures levels of depressive symptomatology, with special emphasis on the affective components and depressed mood.
Time frame: Baseline (V1) and each week evaluation (1 week, 2 weeks, 3 weeks, 4 weeks (V2), 5 weeks, 6 weeks, 7 weeks and the end of the study : 8 weeks (V3))
The visual analog scales will be completed by the subjects at V1 and 2 times a week until 8 weeks. Eight dimensions are observed : stress, spleep, anxiety, happiness, energy feeling, irritability, motivation and pleasure.
Score 0 to 10.
Time frame: Baseline (V1) and each evaluation (2 weeks, 4 weeks (V2), 6 weeks and 8 weeks (V3)
The Snaith-Hamilton Pleasure Scale (SHAPS) score is a 14-item self-reported validated questionnaire evaluating the pleasure. It covers four domains of hedonic experience: interest/pastimes, social interaction, sensory experience and food/drink.
A total score can be calculated by adding the responses to each question, ranging from 0 (no anhedonia) to 14 (complete anhedonia).
Time frame: Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))
This validated self-reported questionnaire is composed of 10 items which cover key aspects of the quality of life, from physical well-being to spiritual fulfilment.
Institut Pasteur de Lille
Other
Chronic Effect of a Standardized Saffron Extract on Depressed Mood and Anhedonia in Healthy Adults. A Randomized Controlled Double-blind Clinical Trial.
Acronym: MOOD5
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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