Depressed Mood and Anhedonia in Healthy Adults

NCT05306093 | Completed

• 1 other identifier: 2021-A02123-38
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anhedonia; Depressed Mood

Keywords

saffron extract

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  at 8 weeks (V3)

Secondary Outcomes (5)

• Tension, anger, vigour, fatigue and confusion evaluated by the five POMS sub-scores

  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

  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

  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

  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)

  Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))

Study Arms (2)

Nutraceutical

EXPERIMENTAL

Daily, 2 dietary supplements will be taken orally with some water, the first one during the breakfast and the second one during the dinner. Dietary supplements in capsule form

Dietary Supplement: Nutraceutical

Maltodextrin

PLACEBO COMPARATOR

Daily, 2 dietary supplements will be taken orally with some water, the first one during the breakfast and the second one during the dinner. Dietary supplements in capsule form

Dietary Supplement: Maltodextrin

Interventions

Nutraceutical DIETARY_SUPPLEMENT

Food supplements are consumed during 8 weeks by healthy volunteers

Nutraceutical

Maltodextrin DIETARY_SUPPLEMENT

Food supplements are consumed during 8 weeks by healthy volunteers

Maltodextrin

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 20 and 65 years (limits included);
• Body Mass Index (BMI) ≥19 and \< 30 kg/m²;
• Considered healthy based on their medical history and clinical examination;
• Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form;
• Affiliated with a social security scheme;
• Agreeing to be registered on the national file of the volunteers in biomedical research.

You may not qualify if:

• Suffer from mental health other than mild depressive or anxiety symptoms as measured by the Patient Health Questionnaire (PHQ-9). Volunteers with PHQ-9 score \>14 could not be included;
• Having suicidal thoughts: score ≥1 at the item 9 of the PHQ-9;
• Diagnosis of medical or psychiatric conditions including (but not limited to):
• psychiatric disorder (other than mild-to-moderate depression symptoms, anhedonia or anxiety),
• neurological disease (Parkinson's, Alzheimer's disease, intracranial haemorrhage, head or brain injury),
• cancer/malignancy,
• cardiovascular disease (other than hypertension),
• Immunological disease,
• endocrine disease (including diabetes or thyroid diseases, Chronic kidney disease, hematological abnormalities);
• Smokers (more than 5 cigarettes per day);
• Uncontrolled hypertension with medication (SBP ≥ 160mmHg or DBP ≥ 100 mmHg) or without medication (SBP ≥ 140mmHg or DBP ≥ 90 mmHg);
• Consuming more than 3 standard drinks of alcoholic beverage daily;
• Currently under prescribed diet regimen, whatever the reason;
• Consuming more than 50g of chocolate/day;
• For females: Pregnant or planning pregnancy during the study or breastfeeding;

Sponsors & Collaborators

• Institut Pasteur de Lille: lead

Study Sites (1)

CEN Experimental

Dijon, 21000, France

Location

MeSH Terms

Conditions

Anhedonia; Consciousness Disorders

Interventions

Dietary Supplements; maltodextrin

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Zakaria NAFLI, MD

  CEN Experimental

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 31, 2022
• Study Start: January 7, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)