Study of the Anxiolytic Effects of Aframomum Seed Extract in Elderly People

NCT06463145 | Completed

• 1 other identifier: AME_HCT_2023
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to evaluate if one specific botanical extract from Grains of Paradise works to induce anxiolytic effect in adult people in stress or anxiety situations It will also learn about the extract's positive effects on sleep and mood. The main questions it aims to answer are: Does botanical extract exert an anxiolytic effect on the participants under stress or anxiety circumstances? Does botanical extract promote positive effects on Mood and nocturnal sleep? Does botanical extract influence body parameters like Blood pressure, inflammatory indicators or stress hormones? Researchers will compare tree doses of botanical extract (50,100 or 150mg) to a placebo (a look-alike substance that contains no herbal product) to see if herbal extract support anxiolytic effect. Participants will: Take herbal extract or a placebo daily for 3 days. Visit the clinic two times: at the start of the study (day0) and to the end of the study (Day +2)for checkups and tests. Keep a diary with questions about their activities, daily foods and physicals perceptions.

Conditions

Situational Anxiety

Keywords

Anxiety; Aframomum melegueta seed; Herbal extract; FAAH inhibitor; Quality sleep; Grains of paradise

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Anxiety Rating Scale (HAM-A) score

  Change in HAM-A score for Vanizem group compared to placebo control group. 14-items questionnaire reflecting 13 categories of anxiety-related symptom to measure anxiety.

  At baseline (day 0) and after intake period (day 2+)

Secondary Outcomes (12)

• Change in Profile of Mood States (POMS) score

  At baseline (day 0) and after intake period (day 2+)

• Change in Pittsburgh Sleep Quality Index (PSQI) score

  At baseline (day 0) and after intake period (day 2+)

• Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score. 10-items evaluating four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness.

  At baseline (day 0) and after intake period (day 1+ and day 2+)

• Change in Heart Rate Variability (HRV)

  At baseline (day 0) and after intake period (day 1+ and day 2+)

• Change in blood pressure score

  At baseline (day 0) and after intake period (day 2+)

Other Outcomes (3)

• Changes in body composition

  At baseline (day 0) and after intake period (day 2+)

• Changes in body weight

  At baseline (day 0) and after intake period (day 2+)

• Changes in body mass index (BMI)

  At baseline (day 0) and after intake period (day 2+)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Pill of Food grade Maltodextrin 12 . Once daily for three days.

Dietary Supplement: Placebo

Vanizem 50mg

EXPERIMENTAL

Pill of Aframomum melegueta extract 50 mg with Food grade Maltodextrin 12 . Once daily for three days.

Dietary Supplement: Vanizem

Vanizem 100mg

EXPERIMENTAL

Pill of Aframomum melegueta extract 100 mg with Food grade Maltodextrin 12 . Once daily for three days.

Dietary Supplement: Vanizem

Vanizem 150mg

EXPERIMENTAL

Pill of Aframomum melegueta extract 150 mg with Food grade Maltodextrin 12 . Once daily for three days.

Dietary Supplement: Vanizem

Interventions

Vanizem DIETARY_SUPPLEMENT

Aframomum melegueta seed extract standardized to 10% of total Vanilloid and at least 1.5% of 6-paradol

Vanizem 100mg; Vanizem 150mg; Vanizem 50mg

Placebo DIETARY_SUPPLEMENT

Food grade Maltodextrin 12

Placebo

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 40 and 50 year of age;
• Healthy people with moderate anxiety: HAM-A score in a range between 18 and 24;
• Subject able and willing to participate to the study by complying with the protocol procedures as confirmed by his dated and signed informed consent form;

You may not qualify if:

• Score greater than 20 points on the Hamilton Depression Rating Scale (HDRS);
• Receiving medical treatment for anxiety, stress or depression;
• Drugs and alcohol dependence;
• Serious personality disorders that may interfere with participation in the study (psychosis, intense suicidal ideation, etc.);
• In the case of women, having the intention of becoming pregnant;
• Epileptic disorders;
• Liver disorders (cirrhosis, hepatitis, etc.);
• Professional athletes or those who frequently engage in extreme physical activities;
• Impossibility of completing the intervention period due to external factors;

Sponsors & Collaborators

• Nektium Pharma SL: lead
• Kinetic performance: collaborator

Study Sites (1)

Kinetic perfomance SL

Alicante, 3005, Spain

Location

Related Publications (8)

• Umukoro S. and Aladeokin A. C., Therapeutic effects of grains of paradise (aframomum melegueta) seeds Nuts and Seeds in Health and Disease Prevention, 2011, Academic Press, Cambridge, MA, USA, 535-543.

  BACKGROUND

• Ilic NM, Dey M, Poulev AA, Logendra S, Kuhn PE, Raskin I. Anti-inflammatory activity of grains of paradise (Aframomum melegueta Schum) extract. J Agric Food Chem. 2014 Oct 29;62(43):10452-7. doi: 10.1021/jf5026086. Epub 2014 Oct 20.

  PMID: 25293633 BACKGROUND

• Ogwu, M.C., Dunkwu-Okafor, A., Omakor, I.A., Izah, S.C. (2024). Medicinal Spice, Aframomum melegueta: An Overview of the Phytochemical Constituents, Nutritional Characteristics, and Ethnomedicinal Values for Sustainability. In: Izah, S.C., Ogwu, M.C., Akram, M. (eds) Herbal Medicine Phytochemistry. Reference Series in Phytochemistry. Springer, Cham. https://doi.org/10.1007/978-3-031-21973-3_72-1

  BACKGROUND

• Umukoro S, Ashorobi RB. Further studies on the antinociceptive action of aqueous seed extract of Aframomum melegueta. J Ethnopharmacol. 2007 Feb 12;109(3):501-4. doi: 10.1016/j.jep.2006.08.025. Epub 2006 Sep 3.

  PMID: 17023130 BACKGROUND

• Ford JL, Ildefonso K, Jones ML, Arvinen-Barrow M. Sport-related anxiety: current insights. Open Access J Sports Med. 2017 Oct 27;8:205-212. doi: 10.2147/OAJSM.S125845. eCollection 2017.

  PMID: 29138604 BACKGROUND

• Halson SL, Juliff LE. Sleep, sport, and the brain. Prog Brain Res. 2017;234:13-31. doi: 10.1016/bs.pbr.2017.06.006. Epub 2017 Jul 17.

  PMID: 29031461 BACKGROUND

• Patel S, Hill MN, Cheer JF, Wotjak CT, Holmes A. The endocannabinoid system as a target for novel anxiolytic drugs. Neurosci Biobehav Rev. 2017 May;76(Pt A):56-66. doi: 10.1016/j.neubiorev.2016.12.033.

  PMID: 28434588 BACKGROUND

• Batista LA, Gobira PH, Viana TG, Aguiar DC, Moreira FA. Inhibition of endocannabinoid neuronal uptake and hydrolysis as strategies for developing anxiolytic drugs. Behav Pharmacol. 2014 Sep;25(5-6):425-33. doi: 10.1097/FBP.0000000000000073.

  PMID: 25083569 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura López-Rios, PhD

  Nektium Pharma SL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the placebo (0 mg) and Botanical extract capsules (50mg, 100mg and 150mg) were identical in appearance to maintain the blindness of the study treatment. Only an unblinded research assistant will have knowledge of which label corresponds to Vanizem doses or placebo. That research assistant will be in charge of: (1) Before each appointment, distributing appropriate treatments or placebo pills into closable pots with a number corresponding to each participant. Care-providers will give closed pots to participants at the time of assessment. (2) Re-labeling all collected data and samples with a participant code number, and sorting into appropriate groups for analysis by blinded researchers.The investigators, study staff, subjects, and statisticians were blinded to the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: March 1, 2023
• Primary Completion: April 12, 2023
• Study Completion: May 20, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)