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

Neurodegenerative Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05947396
• Other study ID #: SMARTO ONE-202305-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Beijing University of Chinese Medicine
• Contact: Li Liu
• Phone: 16619733315
• Email: lily0496[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age: 25-70 years

2. 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

3. 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

4. Patients who can understand and communicate in language, and complete aphasia patients are not included;

5. Patients who agree to participate in this clinical observation and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe organ diseases such as heart, kidney, and liver failure, chronic lung diseases such as COPD, and severe diabetes;

2. Patients with severe uncontrolled hypertension;

3. Patients who have taken antipsychotic drugs within the past two weeks;

4. Patients with the core features of Lewy body dementia or significant behavioral variant frontotemporal dementia;

5. Patients with various malignant tumors;

6. Patients with progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction, and cerebral arteritis;

7. Patients with brain tumors, brain trauma, cerebral parasitic diseases, and other conditions;

8. Pregnant or lactating women;

9. Patients allergic to the known ingredients used in this trial;

10. Patients with active ulcers or bleeding tendencies;

11. Patients with neurodegenerative diseases such as Huntington's disease, amyotrophic lateral sclerosis, and Pick's disease;

12. Other patients who are deemed unsuitable to participate in this trial by the investigators.

Related Conditions & MeSH terms

• Neurodegenerative Diseases

Intervention

Dietary Supplement:
• SMARTO ONE
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.

Other:
• placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mei Han

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numerry of participating with adverse events	This is a safety outcome.	baseline, 4 weeks
Other	Adverse event occurrence rate	This is a safety outcome.	baseline, 4 weeks
Other	Abnormality rate of routine blood tests	This is a safety outcome. Included in the outcome indicators are red blood cell count (WBC), haemoglobin concentration (Hb), white blood cell count (WBC), neutrophil count (Neut), lymphocyte count (Lymph), monocyte count (Mono), eosinophil count (Eos), basophil count (Baso) and platelet count (PLT). The abnormal blood count rate was obtained by dividing the number of people with abnormal blood counts by the total number of people with abnormal blood counts.	baseline, 4 weeks
Other	Liver function-Alanine aminotransferase#ALT#	This is a safety outcome.	baseline, 4 weeks
Other	Liver function-Aspartate aminotransferase (AST)	This is a safety outcome.	baseline, 4 weeks
Other	Liver function-Total Protein(TP)	This is a safety outcome.	baseline, 4 weeks
Other	Electrocardiogram	This is a safety outcome.This outcome measure primarily observes ST segment changes to evaluate the presence or improvement of myocardial ischemia.	baseline, 4 weeks
Other	Body temperature	This is a safety outcome.	baseline, 4 weeks
Other	Heart rate	This is a safety outcome.	baseline, 4 weeks
Other	Number of breaths in 1 min	This is a safety outcome.	baseline, 4 weeks
Other	Blood pressure-Diastolic blood pressure(mmHg)	This is a safety outcome.	baseline, 4 weeks
Other	Blood pressure-Systolic blood pressure(mmHg)	This is a safety outcome.	baseline, 4 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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