Tier 4 — mechanistic

Lifestyle Intervention Program for Cognitive Impairment: BBH-1001 Brain Health Supplement and Lifestyle Intervention in Mild Cognitive Impairment

Ayesha Sherzai
ClinicalTrials.gov trial registry record 2016

Bibliography

Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Sponsor: Cedars-Sinai Medical Center.
Competing interests
Not reported in the registry record.

Study snapshot

DesignRandomized parallel interventional study with supplement/placebo layered onto a comprehensive lifestyle program.
ModelAdults aged 55 years and older with mild cognitive impairment.
SampleAnticipated enrollment: 150 participants.
InterventionBBH-1001: four softgels daily for 18 months. Each softgel contains fisetin 16.65 mg plus turmeric, green-tea extract, EPA, DHA and vitamin D3; total fisetin exposure is 66.6 mg/day. Both groups also receive multidomain lifestyle training.
Duration18 months.
EndpointsRetinal amyloid burden; Cognitive testing; Brain imaging; Inflammatory/metabolic laboratory markers; Vascular risk factors

What the study showed, in plain terms

This Cedars-Sinai study combines a multi-ingredient brain-health supplement with a broad lifestyle program in people with mild cognitive impairment. The supplement supplies 66.6 mg/day of fisetin along with turmeric, green-tea extract, EPA, DHA and vitamin D3.

The registry has not been updated since 2016 and its current status is unknown. Even if outcome data eventually emerge, the design cannot isolate fisetin from the other supplement ingredients and lifestyle changes.

Key findings

  • Planned sample size is 150.
  • BBH-1001 provides 66.6 mg/day fisetin plus several other bioactive ingredients.
  • The intervention lasts 18 months and includes lifestyle training in both groups.
  • Current recruitment/completion status is unknown from the stale registry record.

What this study can and cannot tell us

  • Multi-ingredient supplement prevents fisetin-specific attribution.
  • Lifestyle intervention is a concurrent treatment.
  • Registry status is old/unknown and no fisetin-specific results publication was identified.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology