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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
94
Food supplements are consumed during 8 weeks by healthy volunteers
Food supplements are consumed during 8 weeks by healthy volunteers
CEN Experimental
Dijon, France
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
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)
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
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
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
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)
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
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
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tension, anger, vigour, fatigue and confusion evaluated by the five POMS sub-scores
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 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))
Depression level evaluated by the Center of Epidemiologic Studies Depression scale (CES-D) score
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 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))
Stress, spleep, anxiety, sadness, energy feeling, attention to others and desire to do things evaluated by Visual Analogic Scales (VAS) score
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 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))
Pleasure feeling evaluated by the Snaith-Hamilton Pleasure Scale (SHAPS) score
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 each evaluation (2 weeks, 4 weeks (V2), 6 weeks and 8 weeks (V3)
Quality of life evaluated by the Multicultural Quality of Life Index (MQLI)
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.
Time frame: Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))