CClinicalTrials.gg
CompletedNCT04860050TURMEMICUpdated Jan 18, 2024

Turmeric for Memory Impairment and Cognition

An interventional study of Turmipure Gold® and Placebo in Cognitive Change, Mood and Stress, sponsored by Givaudan France Naturals. Completed at 1 site in Ireland. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-18.

Sponsored by Givaudan France Naturals · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
568
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cognitive Change
  • Mood
  • Stress

Keywords

  • Turmeric
  • Curcuminoids
03

In context

Lead sponsor

Givaudan France Naturals is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
568 participants (actual)

Study arms

  • 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®

  • 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

Interventions

  • Dietary supplementTurmipure Gold®

    TPG: Turmipure GOLD® - 1 capsule per day - as prescribed

  • Dietary supplementPlacebo

    Placebo: colored acacia gum - 1 capsule per day - as prescribed

06

What researchers measure

Primary outcomes

  1. Change in cognitive performance through Quality of Working memory

    Quality of Working memory is a composite score determined by the CDR System™ test battery (unit: #)

    Time frame: 24 weeks

Secondary outcomes

  1. Change in cognitive performance through Power of Attention

    Power of Attention is a composite score determined by the CDR System™ test battery (unit: ms)

    Time frame: 24 weeks

  2. Change in cognitive performance through Continuity of Attention

    Continuity of Attention is a composite score determined by the CDR System™ test battery (unit: #)

    Time frame: 24 weeks

  3. Change in cognitive performance through Cognitive Reaction Time

    Cognitive Reaction Time is a composite score determined by the CDR System™ test battery (unit: ms)

    Time frame: 24 weeks

  4. Change in cognitive performance through Speed of Memory

    Speed of Memory is a composite score determined by the CDR System™ test battery (unit: ms)

    Time frame: 24 weeks

  5. Change in cognitive performance through Quality of Episodic Memory

    Quality of Episodic Memory is a composite score determined by the CDR System™ test battery (unit: #)

    Time frame: 24 weeks

  6. Change in cognitive performance through Quality of Memory

    Quality of Memory is a composite score determined by the CDR System™ test battery (unit: #)

    Time frame: 24 weeks

  7. Change in cognitive performance through Executive Function

    Executive Function is a composite score determined by the CDR System™ test battery (unit: #)

    Time frame: 24 weeks

  8. Change in stress

    Stress will be assessed using the validated scale Perceived Stress Scale (0 to 56, higher scores meaning at maximum stress)

    Time frame: 24 weeks

  9. Change in feelings and emotions

    Mood will be assessed using the validated Positive and Negative Affect Schedule - Expanded Form (PANAS-X) questionnaire

    Time frame: 24 weeks

  10. Change in mood

    Mood will be assessed using the validated Bond-Lader questionnaire

    Time frame: 24 weeks

07

Study locations

1 site
  • Atlantia Food Clinical Trials
    Cork, T23 R50R, Ireland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04860050
Lead sponsor
Givaudan France Naturals
Collaborators
Atlantia Food Clinical Trials
Responsible party
Sponsor
First posted
Apr 26, 2021
Start date
Apr 19, 2021
Primary completion
Aug 10, 2023
Completion
Aug 10, 2023
Last update
Jan 18, 2024

Study contacts

Timothy Dinan, Professor
principal investigator · Atlantia Clinical Food Trials

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion