Turmeric for Memory Impairment and Cognition

NCT ID: NCT04860050

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 568 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2023-08-10

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

TPG

76 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 24 weeks

Group Type: EXPERIMENTAL

Turmipure Gold®

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Turmipure Gold®

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

Givaudan France Naturals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Dinan, Professor

Role: PRINCIPAL_INVESTIGATOR

Atlantia Food Clinical Trials

Locations

Atlantia Food Clinical Trials

Cork, , Ireland

Countries

Ireland

Other Identifiers

AFCRO-125

Identifier Type: -

Identifier Source: org_study_id