Turmeric for Memory Impairment and Cognition (TURMEMIC)

• ClinicalTrials.gov Identifier: NCT04860050
• Recruitment Status: Recruiting
• First Posted: April 26, 2021
• Last Update Posted: June 9, 2021
• Sponsor: Naturex SA
• Collaborator: Atlantia Food Clinical Trials
• Information provided by (Responsible Party): Naturex SA

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Cognitive Change; Mood; Stress	Dietary Supplement: Turmipure Gold®; Dietary Supplement: Placebo	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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.
• Actual Study Start Date: April 19, 2021
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: April 2022

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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: #)

Secondary Outcome Measures :

1. 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)
2. 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: #)
3. 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)
4. 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)
5. 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: #)
6. 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: #)
7. 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: #)
8. 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)
9. 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
10. Change in mood [ Time Frame: 24 weeks ]
    Mood will be assessed using the validated Bond-Lader questionnaire

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Julie Laval, PhD; +33 4 90 23 70 76; julie.laval@givaudan.com

Contact: Pascale Fança-Berthon, PhD; +33 4 90 23 28 40; pascale.fanca-berthon@givaudan.com

Locations

Ireland

Atlantia Food Clinical Trials; Recruiting

Cork, Ireland, T23 R50R

Contact: Emily Goodbody +353(0)214307442 egoodbody@atlantiafoodtrials.com

Contact: Aisling Harrington +353(0)214307442 aharrington@atlantiatrials.com

Sponsors and Collaborators

Naturex SA

Atlantia Food Clinical Trials

Investigators

• Principal Investigator: Timothy Dinan, Professor; Atlantia Clinical Food Trials

More Information

• Responsible Party: Naturex SA
• ClinicalTrials.gov Identifier: NCT04860050
• Other Study ID Numbers: AFCRO-125
• First Posted: April 26, 2021
• Last Update Posted: June 9, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naturex SA:

Turmeric; Curcuminoids