Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases

NCT05947396 | Unknown

• 1 other identifier: SMARTO ONE-202305-1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Explore the effects of natural plant flavonoids on the positive intervention mechanism of neurotransmitter transmission physiological indicators changes (EEG) in the brain of the study subjects;
2. 2.Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects.

Conditions

Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (6)

• Electroencephalogram (EEG)-Slow wave length

  This outcome measure is designed to measure sleep by primarily analyzing slow waves in the resulting graphs. Slow waves are the quality standard of deep sleep, and patients with sleep disorders often fail to produce slow waves or have a shortened slow wave time. If the intervention is effective, the consumption will result in an increase in the duration of slow wave sleep.The length of the slow wave per minute is obtained by measuring the length of the slow wave for two consecutive hours and dividing by the total duration of 120 minutes.

  4 weeks

• Electroencephalogram (EEG)-Slow wave frequency

  This outcome measure is designed to measure sleep by primarily analyzing slow waves in the resulting graphs. Slow waves are the quality standard of deep sleep, and patients with sleep disorders often fail to produce slow waves or have a shortened slow wave time. If the intervention is effective, the consumption will result in an increase in the duration of slow wave sleep.The frequency of slow waves per minute is obtained by measuring the number of slow waves in two hours divided by 120 minutes.

  4 weeks

• Montreal Cognitive Assessment (MoCA)

  This outcome measure assesses cognitive ability and memory, with evaluation based on a scoring system.The total score ranges from 0 to 30 points, with scores lower than 26 indicating the presence of cognitive impairment. The lower the score, the more severe the disease.

  4 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  The evaluation criteria for this outcome measure are as follows: 0-5 points indicate very good sleep quality; 6-10 points indicate average sleep quality; 11-15 points indicate poor sleep quality; 16-21 points indicate very poor sleep quality.

  4 weeks

• Hamilton Anxiety Rating Scale (HAMA)

  The evaluation criteria for this outcome measure are as follows: 0-6 points indicate no anxiety symptoms; 7-14 points indicate possible anxiety; 15-21 points indicate definite anxiety; 22-29 points indicate significant anxiety; and scores exceeding 29 points suggest severe anxiety.

  4 weeks

• Hamilton Depression Scale(HAMD)

  The evaluation criteria for this outcome measure are as follows:a score of less than 8 is normal, a score of 8-20 may indicate depression, a score of 21-35 may indicate depression, and a score of more than 35 may not indicate severe depression

  4 weeks

Other Outcomes (12)

• Numerry of participating with adverse events

  baseline, 4 weeks

• Adverse event occurrence rate

  baseline, 4 weeks

• Abnormality rate of routine blood tests

  baseline, 4 weeks

Study Arms (2)

SMARTO ONE

EXPERIMENTAL

Dietary Supplement: SMARTO ONE

placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

SMARTO ONE DIETARY_SUPPLEMENT

The SMARTO ONE® small molecule natural flavonoid compound product is provided by Beijing Jiafurui Biological Technology Co., Ltd. The intervention agent formula consists of extracts from Polygonum cuspidatum leaves, Fructus ligustri lucidi, Prunus mume, Semen ziziphi spinosae, celery, resistant maltodextrin, and steviol glycoside. Each package of the test product (3g) contains a total flavonoid content of 150mg.

SMARTO ONE

placebo OTHER

The placebo is provided by Beijing Jiafurui Biological Technology Co., Ltd. The formula consists of maltodextrin, grapefruit powder, and food coloring. The manufacturing facility has adjusted the appearance, color, solubility, and taste of the placebo to match the intervention agent. There is no risk of unblinding.

placebo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 25-70 years
• Patients complaining of sleep disorders, mood disorders (unstable mood, irritability, depression, and anxiety), and cognitive decline (people with memory, decreased reaction time, BPSD symptoms) within one month
• Montreal Cognitive Assessment Scale (MOCA) score ≤26; if the MOCA score is not satisfied, then Pittsburgh Sleep Quality Index (PSQI) score \>10 and Hamilton Anxiety Scale (HAMA) score \>14 or Hamilton Depression Scale (HAMD) score ≥8 are required
• Patients who can understand and communicate in language, and complete aphasia patients are not included;
• Patients who agree to participate in this clinical observation and sign the informed consent form.

You may not qualify if:

• Patients with severe organ diseases such as heart, kidney, and liver failure, chronic lung diseases such as COPD, and severe diabetes;
• Patients with severe uncontrolled hypertension;
• Patients who have taken antipsychotic drugs within the past two weeks;
• Patients with the core features of Lewy body dementia or significant behavioral variant frontotemporal dementia;
• Patients with various malignant tumors;
• Patients with progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction, and cerebral arteritis;
• Patients with brain tumors, brain trauma, cerebral parasitic diseases, and other conditions;
• Pregnant or lactating women;
• Patients allergic to the known ingredients used in this trial;
• Patients with active ulcers or bleeding tendencies;
• Patients with neurodegenerative diseases such as Huntington's disease, amyotrophic lateral sclerosis, and Pick's disease;
• Other patients who are deemed unsuitable to participate in this trial by the investigators.

Sponsors & Collaborators

• Mei Han: lead

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Li Liu

CONTACT

16619733315; lily0496@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator,

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 17, 2023
• Study Start: August 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: December 31, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08