Turmeric for Memory Impairment and Cognition

NCT04860050 | Completed

• 1 other identifier: AFCRO-125
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Change; Mood; Stress

Keywords

Turmeric; Curcuminoids

Outcome Measures

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: #)

  24 weeks

Secondary Outcomes (10)

• Change in cognitive performance through Power of Attention

  24 weeks

• Change in cognitive performance through Continuity of Attention

  24 weeks

• Change in cognitive performance through Cognitive Reaction Time

  24 weeks

• Change in cognitive performance through Speed of Memory

  24 weeks

• Change in cognitive performance through Quality of Episodic Memory

  24 weeks

Study Arms (2)

TPG

EXPERIMENTAL

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®

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

Dietary Supplement: Placebo

Interventions

Turmipure Gold® DIETARY_SUPPLEMENT

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

TPG

Placebo DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Abnormal laboratory test results of clinical significance
• 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

Sponsors & Collaborators

• Givaudan France Naturals: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Location

Study Officials

• Timothy Dinan, Professor

  Atlantia Food Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 26, 2021
• Study Start: April 19, 2021
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

IE (1)