Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress

NCT04750681 | Completed

• 1 other identifier: Saffractiv2019
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Therefore, the aim of this study was to confirm by a randomized double-blind controlled study the beneficial effects of saffron extract (Saffr'activ®) on sleep quality in subjects presenting mild to moderate sleep disorder associated with anxiety.

Conditions

Insomnia; Stress

Outcome Measures

Primary Outcomes (1)

• Change from baseline Leeds Sleep Evaluation Questionnaire score at 42 days

  Questionnaire, score 0-100, higher score = better

  Baseline (day-7 and day 0) and day 42 (end of the study)

Secondary Outcomes (11)

• Change from baseline Leeds Sleep Evaluation Questionnaire score at 21 days

  Baseline (day -7 and day 0) and day 21

• Pittsburgh Sleep Quality Index

  Baseline (day -7 and day 0) and day 42 (end of the study)

• Epworth Sleepiness Scale

  Baseline (day-7 and day 0), day 21 and day 42 (end of the study)

• Perceived Stress Scale

  Baseline (day -7 and day 0) and day 42 (end of the study)

• Short Form (36) Health Survey

  Baseline (day -7 and day 0) and day 42 (end of the study)

Study Arms (2)

Control

PLACEBO COMPARATOR

Each capsule contained 275mg of maltodextrin. Capsules were similar to the saffron investigation product (chlorophyll capsules).

Dietary Supplement: Placebo

Saffron

EXPERIMENTAL

Each capsule contained 259,5mg of maltodextrin and 15,5mg of saffron extract (Saffr'activ® SAF 3C PIM) that corresponds to 1,6mg of dry saffron extract, 0,9mg of crocins (5.82%) and 0,7mg of safranal (4.6%).

Dietary Supplement: Saffron

Interventions

Placebo DIETARY_SUPPLEMENT

Subjects orally ingested, with water, one capsule per day (in the evening)

Control

Saffron DIETARY_SUPPLEMENT

Subjects orally ingested, with water, one capsule per day (in the evening)

Saffron

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In good general health as evidenced by medical history and physical examination;
• Presenting mild to moderate chronic primary sleep disorder (evaluated by Insomnia Severity Index - ISI, score between 7 and 21);
• Presenting mild to moderate anxiety (evaluated by Perceived Stress Scale - PSS, score between 6 and 29);
• For women: use of effective contraception;
• Fluent French speaking;
• Provision of signed and dated informed consent form;
• Stated willingness to comply with all study procedures and availability for the duration of the study.

You may not qualify if:

• Sleep disorders secondary to another health problem;
• Lifestyle habits which would modify the wake-sleep rhythm (e.g. night work) or which would be modified during the study period;
• Abnormal blood sampling;
• Subjects presenting depressive disorder (BDI score \> 30);
• Addict subjects or with historical addiction;
• Subjects who drink more than 3 glasses of alcohol per day (\> 30g of alcohol per day);
• Exaggerated consumption of theine (≥ 500ml per day) and caffeine-rich (≥ 400ml per day) beverages and energy drink (≥ 250ml per day);
• Pregnant or lactating woman;
• Known allergy to saffron and/or olives;
• Subjects having participated to another clinical trial one month before the selection visit.

Sponsors & Collaborators

• Comercial Quimica Masso, S.A: lead
• Université Catholique de Louvain: collaborator

Study Sites (1)

UCLouvain - CICN

Louvain-la-Neuve, 1348, Belgium

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Sylvie Copine, Dr

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized double-blind placebo-controlled interventional study

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 11, 2021
• Study Start: August 12, 2019
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)