Cognitive ChangeTURMEMICNCT04860050
Turmeric for Memory Impairment and Cognition
A study testing Turmipure Gold® in people with Cognitive Change and Mood, run by Givaudan France Naturals at 1 site in Ireland.
Trial 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 more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Mood, Stress
- What is being tested?
- Turmipure Gold®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 568 participants
- Where
- 1 siteIreland
- Study dates
- 19 Apr 2021to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
- Subjective memory complaint reflected in everyday difficulties (gradual) confirmed with a MAC-Q ≥25
- Memory loss confirmed by a 1st degree relative or life-partner
- 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)
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- Evidence of adequate intellectual function as determined by the Vocabulary subset of the Wechsler Adult Intelligence Scale
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Cognitive Change, Mood, Stress
- Being tested
- Turmipure Gold®, Placebo
- Keywords
- Turmeric, Curcuminoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turmipure Gold®Dietary supplement
TPG: Turmipure GOLD® - 1 capsule per day - as prescribed
PlaceboDietary supplement
Placebo: colored acacia gum - 1 capsule per day - as prescribed
| Study group | Role | What they receive |
|---|---|---|
| TPG | Experimental | 76 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 24 weeks Receives: Dietary Supplement: Turmipure Gold® |
| Control | Placebo comparator | 76 participants who meet the eligibility criteria will be randomized under experimental arm and will receive placebo (colored acacia gum) product during 24 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: #)
Measured: 24 weeks
Secondary outcomes (10)
Change in cognitive performance through Power of Attention
Power of Attention is a composite score determined by the CDR System™ test battery (unit: ms)
Measured: 24 weeks
Change in cognitive performance through Continuity of Attention
Continuity of Attention is a composite score determined by the CDR System™ test battery (unit: #)
Measured: 24 weeks
Change in cognitive performance through Cognitive Reaction Time
Cognitive Reaction Time is a composite score determined by the CDR System™ test battery (unit: ms)
Measured: 24 weeks
Change in cognitive performance through Speed of Memory
Speed of Memory is a composite score determined by the CDR System™ test battery (unit: ms)
Measured: 24 weeks
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: #)
Measured: 24 weeks
Change in cognitive performance through Quality of Memory
Quality of Memory is a composite score determined by the CDR System™ test battery (unit: #)
Measured: 24 weeks
Change in cognitive performance through Executive Function
Executive Function is a composite score determined by the CDR System™ test battery (unit: #)
Measured: 24 weeks
Change in stress
Stress will be assessed using the validated scale Perceived Stress Scale (0 to 56, higher scores meaning at maximum stress)
Measured: 24 weeks
Change in feelings and emotions
Mood will be assessed using the validated Positive and Negative Affect Schedule - Expanded Form (PANAS-X) questionnaire
Measured: 24 weeks
Change in mood
Mood will be assessed using the validated Bond-Lader questionnaire
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start19 Apr 2021
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Professor, Principal investigator, Atlantia Food Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860050
- Sponsor's protocol ID
- AFCRO-125
- Acronym
- TURMEMIC
- Status last verified
- Jan 2024
- First submitted
- 13 Apr 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Parallel, Placebo-controlled, Randomised Clinical Trial to Evaluate the Efficacy of Turmipure Gold® to Improve Cognitive Performance in Healthy Aging.
- ClinicalTrials.gov ID
- NCT04860050
- Acronym / sponsor ID
- TURMEMIC / AFCRO-125
- Conditions
- Cognitive Change, Mood, Stress
- Keywords
- Turmeric, Curcuminoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Givaudan France NaturalsIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPG | Experimental | Dietary Supplement: Turmipure Gold®76 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 24 weeks |
| Control | Placebo comparator | Dietary Supplement: Placebo76 participants who meet the eligibility criteria will be randomized under experimental arm and will receive placebo (colored acacia gum) product during 24 weeks |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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):
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turmipure Gold®TPG: Turmipure GOLD® - 1 capsule per day - as prescribed | Dietary supplement | TPG |
| PlaceboPlacebo: colored acacia gum - 1 capsule per day - as prescribed | Dietary supplement | Control |
Primary outcome
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: #)
10 secondary outcomes
Change in cognitive performance through Power of Attention
Time frame: 24 weeks
Change in cognitive performance through Continuity of Attention
Time frame: 24 weeks
Change in cognitive performance through Cognitive Reaction Time
Time frame: 24 weeks
Change in cognitive performance through Speed of Memory
Time frame: 24 weeks
Change in cognitive performance through Quality of Episodic Memory
Time frame: 24 weeks
Change in cognitive performance through Quality of Memory
Time frame: 24 weeks
Change in cognitive performance through Executive Function
Time frame: 24 weeks
Change in stress
Time frame: 24 weeks
Change in feelings and emotions
Time frame: 24 weeks
Change in mood
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Dinan, Professor principal investigator
Atlantia Food Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turmipure Gold® in people with Cognitive Change and Mood, run by Givaudan France Naturals at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performance through Quality of Working memory (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.