INAF-2012-242

About this trial

Last updated 10 years ago

Study ID

INAF-2012-242

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Yes

Accepting

60 to 70 Years

All

Trial Timing

Ended 10 years ago

Several preliminary studies have shown that diet can have beneficial effects on cognitive decline. Among food shown to have such effects are some polyphenols from selected botanicals. Preclinical studies have concluded that polyphenols play a role in moderation of oxidative stress and inflammation, increased neuronal signaling, and improved metabolic function among other effects. Noteworthy, a positive and statistically significant association between the midlife level of polyphenol intake and cognitive function assessed 13 years later was found in a cohort of 2574 adults. Several mechanisms may be involved in these positive effects of food polyphenols on cognitive function in older adults: experimental studies suggest that polyphenols display neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and inducing neurogenesis, and might prevent age-related damage to the central nervous system through their antioxidant and anti-inflammatory activities. Based on these promising results, a food supplement from botanicals offering complementary polyphenol profile was developed. This food supplement is aimed to aid at maintenance of cognitive function in older adults.

Inclusion Criteria

- Independent subjects, living at home;

- Body Mass Index (BMI) 20-30 kg/m2 (limits included);

- 26 < MMSE score ≤ 29

- Logical memory subtest of the Wechsler Memory Scale (16-69 years battery) sub-scores complying with the following:

- Immediate recall score < 29;

- Delayed recall score < 16;

Exclusion Criteria

- Evidence of actual major depressive disorder according to the module A of the Mini International Neuropsychiatric Interview (MINI);

- Subject consuming food supplements likely to have an effect on memory;

- High physical activity practice;

- Restrictive or unbalanced diet (hypocaloric, vegetarian, vegan, …) self-declared at V0;

- Diabetes;

- Cardiovascular disease diagnosed within less than 2 years, with the following exceptions: subjects with controlled (medicated) high blood pressure and/ or controlled (medicated) can be included;

- Personal history of Cerebrovascular Accident (CVA);

- Unbalanced thyroid disease;

- Anti-depressant treatment stopped since less than 3 months or still ongoing;

- Personal history of schizophrenia or other psychiatric disorders;

- Ongoing neuroleptic treatment;

- Uncorrected visual or auditory dysfunction (according to the volunteer's self-declaration);

- History of moderate to severe traumatic brain injury and / or intracranial surgery;

- Life threatening pathology (such as cancer) in remission for less than 1 year or still ongoing;

- General anesthesia in the last 6 months or planned in the next 6 months;

- Documented food allergy(ies), namely to one of the components of the study product;

- Psychological or linguistic incapability to sign the informed consent.

Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults