Depressed Mood and Anhedonia in Healthy Adults

NCT ID: NCT05306093

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2022-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Nutraceutical

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

Group Type: EXPERIMENTAL

Nutraceutical

Intervention Type: DIETARY_SUPPLEMENT

Food supplements are consumed during 8 weeks by healthy volunteers

Maltodextrin

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

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Food supplements are consumed during 8 weeks by healthy volunteers

Interventions

Nutraceutical

Food supplements are consumed during 8 weeks by healthy volunteers

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Food supplements are consumed during 8 weeks by healthy volunteers

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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;
• Subjects self-reporting anhedonia based on SHAPS questionnaire. Score ≥ 3 allows the inclusion;
• Subjects with depressive mood disturbance based on POMS depression subscale. Score ≥ 4 allows the inclusion;
• 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.

Exclusion Criteria

• 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);
• Taking drugs (anxiolytics, antidepressants, antihistamine drug more than 7 day/month) known to have an impact on mental health in the month preceding inclusion and / or likely to consume them during the study and/or Illicit drug;
• Undergoing a psychotherapy in the month preceding inclusion or during the study;
• Consuming more than 3 standard drinks of alcoholic beverage daily;
• Weight change above 10% body weight within the past 6 months before inclusion;
• Currently under prescribed diet regimen, whatever the reason;
• Consuming foods supplement known to have an influence on mental health in the month preceding the inclusion and / or likely to take during the study;
• Consuming more than 50g of chocolate/day;
• For females: Pregnant or planning pregnancy during the study or breastfeeding;
• Any intolerance or allergy documented or suspected to one of the components of the study products;
• Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;
• Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study;
• Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
• Presenting a psychological or linguistic incapability to sign the informed consent and to answer the study questionnaires
• Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Pasteur de Lille

OTHER

Sponsor Role: lead

Responsible Party

Jean-Michel Lecerf

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zakaria NAFLI, MD

Role: PRINCIPAL_INVESTIGATOR

CEN Experimental

Locations

CEN Experimental

Dijon, , France

Countries

France

Other Identifiers

2021-A02123-38

Identifier Type: -

Identifier Source: org_study_id