A Double Blind, Parallel, Placebo-controlled, Randomised Clinical Trial to Evaluate the Efficacy of Turmipure Gold® to Improve Cognitive Performance in Healthy Aging.

Givaudan France Naturals1 site in 1 country568 target enrollmentApril 19, 2021

ConditionsCognitive Change Mood Stress

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cognitive Change
Sponsor: Givaudan France Naturals
Enrollment: 568
Locations: 1
Primary Endpoint: Change in cognitive performance through Quality of Working memory
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 19, 2021

End Date

August 10, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Givaudan France Naturals

Responsible Party

Sponsor

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):
•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

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