ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS

NCT03639831 | Completed

• 1 other identifier: PTC198-2017
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Mood disorders, including depression and anxiety, are one of the main causes of the overall disease burden worldwide. In recent years, the efficacy of certain botanicals as an alternative solution for depression has been evaluated in a number of clinical trials. However, only few studies looked at the effects of these botanicals on mood in healthy subjects. The aim of the proposed randomised, double-blind, placebo-controlled, parallel groups methodology is to assess the acute and chronic effects of daily supplementation with a proprietary and standardized botanical extract in comparison to placebo in healthy adults aged 18-60 years with self-reported low mood.

Conditions

Mood Disorders

Keywords

Mood; Anxiety; Stress; Dietary supplement; Botanical

Outcome Measures

Primary Outcomes (1)

• Mood state

  Variation of the Profile of mood states (POMS-2) total score: TMD (Total Mood Disturbance score). The POMS-2 is a scale which includes six mood subscales: Anger, Confusion, Depression, Fatigue, Tension, and Vigor. Each subscale is scored between 0 and 100. TMD is determined by summing the Negative Mood State subscores and subtracting the Vigor subscore (unique Positive Mood State subscale). For each subscale except Vigor, a lower subscore indicates a better mood state. For the Vigor subscale, a higher subscore indicates a better mood state. A lower POMS-2 TMD indicates a better mood state.

  Week 8

Secondary Outcomes (18)

• POMS-2 subscores

  week 2, week 4, week 8

• Anxiety state State-Trait Anxiety Inventory

  week 2, week 4, week 8

• Anxiety state according to the Hospital Anxiety and Depression Scale

  week 2, week 4, week 8

• Percentage of responders

  week 2, week 4, week 8

• Psychological stress

  week 2, week 4, week 8

Other Outcomes (2)

• Bioavaialability

  week 2, week 4 & week 8

• Biomarqueurs of oxidative damage

  week 2, week 4 & week 8

Study Arms (2)

Active group

EXPERIMENTAL

Proprietary, standardized botanical extract

Dietary Supplement: Proprietary, standardized botanical extract

Placebo group

PLACEBO COMPARATOR

Placebo (maltodextrin)

Dietary Supplement: Placebo (maltodextrin)

Interventions

Proprietary, standardized botanical extract DIETARY_SUPPLEMENT

2 capsules/ day providing the proprietary botanical extract as unique active ingredient

Active group

Placebo (maltodextrin) DIETARY_SUPPLEMENT

2 capsules/ day providing no active component

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• With non-pathological feelings of anxiety and/ or stress in daily life:
• Subjects self-reporting low mood;
• Total score ≥ 40 at the Profile of Mood State (POMS 2);
• Score \< 16 at the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire
• Score ≤ 10 at the Patient Health Questionnaire 9-item (PHQ-9)
• Not meeting the diagnosis criteria for any mental disorder
• Body Mass Index (BMI) in the normal range: 18.5 ≥ BMI ≤ 30 kg/ m2
• For non-menopausal women: using effective contraception/pregnancy is not physiologically possible.
• Subject showing no difficulty for salivary sampling
• Subjects capable of and willing to comply with the protocol and to give their written informed consent

You may not qualify if:

• Diagnosis of psychological pathology within the previous 3 years
• Diagnosis of cognitive pathology
• Anxiolytic or antidepressant treatment, within the previous 3 months
• Event likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks or planned during the next 8 weeks
• Menopausal transition
• High blood pressure
• Subjects diagnosed with diabetes, cardiovascular disease, recurrent infectious diseases or chronic inflammatory pathology
• Usual corticoid treatment/ steroidal anti-inflammatory treatment
• Unbalanced thyroid disease
• High physical activity practice
• Tobacco consumption
• Subjects consuming any food supplement
• Excessive alcohol or caffeine use
• Consumption of recreational drugs
• Subject currently participating in other clinical or nutrition intervention studies, or has done in the past 4 weeks.

Sponsors & Collaborators

• Activ'inside: lead
• Northumbria University: collaborator

Study Sites (1)

Brain, Performance and Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

Related Publications (1)

• Jackson PA, Forster J, Khan J, Pouchieu C, Dubreuil S, Gaudout D, Moras B, Pourtau L, Joffre F, Vaysse C, Bertrand K, Abrous H, Vauzour D, Brossaud J, Corcuff JB, Capuron L, Kennedy DO. Effects of Saffron Extract Supplementation on Mood, Well-Being, and Response to a Psychosocial Stressor in Healthy Adults: A Randomized, Double-Blind, Parallel Group, Clinical Trial. Front Nutr. 2021 Feb 1;7:606124. doi: 10.3389/fnut.2020.606124. eCollection 2020.

  PMID: 33598475 DERIVED

MeSH Terms

Conditions

Mood Disorders; Anxiety Disorders

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• David KENNEDY, PhD

  Brain, Performance and Nutrition Research Centre - Northumbria University

  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

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 21, 2018
• Study Start: November 6, 2017
• Primary Completion: November 15, 2018
• Study Completion: March 31, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)