Turmeric for Memory Impairment and Cognition (TURMEMIC)

January 17, 2024 updated by: Naturex SA

A Double Blind, Parallel, Placebo-controlled, Randomised Clinical Trial to Evaluate the Efficacy of Turmipure Gold® to Improve Cognitive Performance in Healthy Aging.

The objective of the study is to test the capacity of acute and chronic supplementations of Turmipure GOLD® to improve cognitive performance in healthy aging

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this clinical study is to determine whether oral administration of Turmipure GOLD® can contribute to the short- and long-term improvement of cognitive functions, including memory and attention, in subjects with age-associated memory impairment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
568

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland, T23 R50R
        • Atlantia Food Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Consent to the study and willing/able to comply with study product
  • Males and females aged ≥ 60 and ≤ 85 years old

  • Participants with subjective memory impairment, with preserved global cognitive functions, everyday activities, and no dementia, fulfilling age-associated memory impairment criteria based on the following National Institute of Mental Health criteria (AAMI, Crook 1986):

    1. Subjective memory complaint reflected in everyday difficulties (gradual) confirmed with a MAC-Q ≥25
    2. Memory loss confirmed by a 1st degree relative or life-partner
    3. Memory test performance that is at least 1SD below the mean established for healthy adults on a standardised test of secondary memory (VPA I and II portions of the Wechsler Memory Scale IV)
    4. Evidence of adequate intellectual function as determined by the Vocabulary subset of the Wechsler Adult Intelligence Scale
    5. Absence of dementia, as determined by the Telephone - Mini-Mental State Examination (MMSE) predicted in person score ≥24
  • Not suffering from depression or anxiety, as determined by the Hospital Anxiety and Depression Scale (HADs) score of ≤7 for both depression and anxiety
  • With a BMI between 18 and 32 kg/m²
  • With a glycated haemoglobin/A1C score ≤ 5.7 %
  • Willing to maintain existing dietary, body weight, and physical activity patterns throughout the study period

Exclusion Criteria:

  • Abnormal laboratory test results of clinical significance
  • With significant cardiovascular history, or significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives, as deemed exclusionary by the Principal Investigator
  • With history of major head trauma, chronic traumatic encephalopathy, epilepsy, cerebrovascular disease, stroke or clinically diagnosed with mild cognitive impairment or dementia (such as Alzheimer's Disease according to the NINCDS-ADRDA guidelines), acute psychiatric disorder, schizophrenia, mania, depression (within past 24 months) or under any concurrent medical, cognitive or psychiatric condition that would either: compromise his/her ability to comply with the study requirements, may pose significant risk to the subject, or be deemed exclusionary by the Principal Investigator
  • History of heavy smoking (> 1 pack/day) within past 3 months
  • History of heavy caffeinated beverage consumption (> 400 mg caffeine/day) within past 2 weeks
  • Taking any supplements or vitamins notably known to affect cognitive function (e.g. Living Nutrition Cognitive, Viridian Cognitive Complex, fish oil etc., list not exhaustive), or any psychotropic medications and products which interact with acetylcholine esterase and/or NMDA receptors (6-week washout before screening). Vitamin D and Calcium supplements permitted if on a stable dose for the previous 3 months
  • Participant with history of drug and/or alcohol abuse at the time of enrolment
  • Significant change of dietary habits within the preceding month
  • With known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon or significant systemic disease, and with history of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
  • Participant with known allergy to components of the test product or with a medical history of food allergies
  • Having uncontrolled hypertension, uncontrolled hypothyroidism or hyperthyroidism or uncontrolled lipidaemia (hypercholesteremia or hypertriglyceridemia) that is not on stable medication for at least 3 months.
  • Current illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation/severe, difficulty swallowing)
  • Participants taking any anticoagulant (including aspirin) or heparin treatment
  • Participant currently involved in any other clinical trial or having participated in a trial within the preceding 90 days
  • Individuals who are unable to give informed consent
  • Participant has a history of non-compliance with medical treatments or recommendations
  • Occupations that resulted in disruption of sleep-wake cycles
  • Participant has difficulty hearing with or without a hearing aid or is colour blind or is visually impaired

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TPG
76 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 24 weeks
Dietary supplement: Turmipure Gold®
TPG: Turmipure GOLD® - 1 capsule per day - as prescribed
Placebo Comparator: Control
76 participants who meet the eligibility criteria will be randomized under experimental arm and will receive placebo (colored acacia gum) product during 24 weeks
Dietary supplement: Placebo
Placebo: colored acacia gum - 1 capsule per day - as prescribed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in cognitive performance through Quality of Working memory
Time Frame: 24 weeks
Quality of Working memory is a composite score determined by the CDR System™ test battery (unit: #)
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in cognitive performance through Power of Attention
Time Frame: 24 weeks
Power of Attention is a composite score determined by the CDR System™ test battery (unit: ms)
24 weeks
Change in cognitive performance through Continuity of Attention
Time Frame: 24 weeks
Continuity of Attention is a composite score determined by the CDR System™ test battery (unit: #)
24 weeks
Change in cognitive performance through Cognitive Reaction Time
Time Frame: 24 weeks
Cognitive Reaction Time is a composite score determined by the CDR System™ test battery (unit: ms)
24 weeks
Change in cognitive performance through Speed of Memory
Time Frame: 24 weeks
Speed of Memory is a composite score determined by the CDR System™ test battery (unit: ms)
24 weeks
Change in cognitive performance through Quality of Episodic Memory
Time Frame: 24 weeks
Quality of Episodic Memory is a composite score determined by the CDR System™ test battery (unit: #)
24 weeks
Change in cognitive performance through Quality of Memory
Time Frame: 24 weeks
Quality of Memory is a composite score determined by the CDR System™ test battery (unit: #)
24 weeks
Change in cognitive performance through Executive Function
Time Frame: 24 weeks
Executive Function is a composite score determined by the CDR System™ test battery (unit: #)
24 weeks
Change in stress
Time Frame: 24 weeks
Stress will be assessed using the validated scale Perceived Stress Scale (0 to 56, higher scores meaning at maximum stress)
24 weeks
Change in feelings and emotions
Time Frame: 24 weeks
Mood will be assessed using the validated Positive and Negative Affect Schedule - Expanded Form (PANAS-X) questionnaire
24 weeks
Change in mood
Time Frame: 24 weeks
Mood will be assessed using the validated Bond-Lader questionnaire
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Naturex SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Atlantia Food Clinical Trials

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy Dinan, Professor, Atlantia Clinical Food Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFCRO-125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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