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Safety study of health food containing 5-aminolevulinic acid phosphate in patients with COVID-19 sequelae using smart watch and electronic research collaborator diary.

Safety study of health food containing 5-aminolevulinic acid phosphate in patients with COVID-19 sequelae using smart watch and electronic research collaborator diary.

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<PL Group> [Gender, n(%)] male, 8 (42.1%); female,11 (57.9%) [Age, years (SD)] 44.8 (12.0) [Race, n(%)]Asian,19(100%);Black,0(0%);Caucasian,0(0%) [COVID-19 aftereffects, n(%)]feeling of dyspnea,6(31.6%);memory impairment,7(36.8%);hair removal,4(21.1%);chest pain,8(42.1%);low concentration,18(94.7%);arthralgia,7(36.8%);dysosmia,10(52.6%);dysgeusia,9(47.4%);cough,8(42.1%);xerosis,7(36.8%);rhinitis,9(47.4%);inflammation,3(15.8%) [Medicalhistory, n(%)]not applicable,15(78.9%);applicable,4(21.1%) [Complications, n(%)]not applicable,13(68.4%);applicable ,6(31.6%) [Pretreatment history, n(%)]not applicable,19(100%);applicable,0(0%) [Combined medicine, n(%)]not applicable,10(52.6%);applicable,9(47.4%) <5A Group> [Gender, n(%)] male, 9(42.9%); female,12(57.1%) [Age, years (SD)] 40.3(11.6) [Race, n(%)]Asian,21(100%);Black,0(0%);Caucasian,0(0%) [COVID-19 aftereffects, n(%)]feeling of dyspnea,8(38.8%);memory impairment,6(28.6%);hair removal,6(28.6%);chest pain,9(42.9%);low concentration,17(81%);arthralgia,5(23.8%);dysosmia,8(38.1%);dysgeusia,5(23.8%);cough,4(19%);xerosis,5(23.8%);rhinitis,4(19%);inflammation,3(14.3%) [Medical history, n(%)]not applicable,17(81%);applicable,4(19%) [Complication, n(%)]not applicable,14(66.7%);applicable,7(33.3%) [Pretreatment history, n(%)]not applicable,20(95.2%);applicable,1(4.8%) [Combined medicine, n(%)] not applicable,8(38.1%);applicable,13(61.9%)

May 31, 2021: Start of the study May 31, 2021: Start of the enrollment August 26, 2021: End of the enrollment October 14,2021: End of the study period for all research subjects

PL Group : 1case (arthralgia of left ancle (1)) 5A Group : 3cases(Acute Gastroenteritis(1),diarrhea(1),Wheal(1))

<Primary endpoint: Evaluation of safety for patients with sequelae of COVID-19> There was no statistically significant difference in the frequency of adverse events between the two groups (5A group and PL group). <Secondary endpoint> 1) Changes in VAS values for fatigue and rate of change In the PL group, there was no statistically significant variation from the screening period to the fourth week of the intake period (screening period: 54.23 +/- 20.65 [mean +/-SD]; intake period, fourth week: 60.78 +/- 16.30, P = 0.305). The 5A group also showed no statistically significant changes from the screening period to the fourth week of intake (screening period: 55.60 +/- 14.71 [mean +/-SD]; fourth week of intake: 54.43 +/- 17.02, P = 0.520). There was no statistically significant difference between the PL and 5A groups at all measurement points. 2) Pittsburgh Sleep Quality Index In the PL group, there were no statistically significant changes in PSQIG from Day 0 to Day 29 (Day 0: 8.6 +/- 2.8, Day 29: 8.2 +/- 2.9, P = 0.247). the 5A group also showed no statistically significant changes from Day 0 to Day 29 (Day 0: 7.3 +/- 2.4, Day 29: 7.2 +/- 2.3, P = 0.887). 3) Changes in COVID-19 posterior symptom scores There was no statistically significant difference between the PL and 5A groups in terms of changes in COVID-19 sequelae symptom scores. 4) Change in EQ5D5L score 5A group showed a statistically significant improvement in QOL from Day 0 to Day 29 for "Today's ease of movement," "Today's state of normal activities," and "Today's state of anxiety and depressed mood" (P = 0.005, P = 0.003, and P = 0.033, respectively). On the other hand, there was no statistically significant difference between the PL and 5A groups at each measurement point for all items. In the VAS scale asking patient's self-rated health, the PL group showed a statistically significant increase from Day 0 to Day 29 (Day 0: 52.8 +/- 18.9, Day 29: 63.6 +/- 18.1, P = 0.033). On the other hand, the 5A group showed no statistically significant changes from Day 0 to Day 29 (Day 0: 58.3 +/- 17.4, Day 29: 62.9 +/- 16.4, P = 0.702). Furthermore, there was no statistically significant difference between the PL and 5A groups at each measurement point. 5) Changes and rates of change in the results of activity (amount of activity), body battery (energy status of the body), stress, and sleep analysis acquired by the smartwatch. (1) Active (kcal) In the PL group, Active values were significantly lower in the 1st and 4th week of intake period compared to the screening period (screening period: 453.21 +/- 247.26, 1st week of intake period: 352.41 +/- 201.39; P = 0.048, 4th week of intake period: 358.05 +/- 238.25; P = 0. 006). On the other hand, there was no statistically significant in the 5A group. Comparison of the PL and 5A groups at each measurement point showed that the Active value was statistically significantly lower in the 5A group than in the PL group at the screening period (P = 0.030). (2) Active time (sec/day) In the PL group, the Active Time value was significantly lower at week 4 of the intake period compared to the screening period (screening period: 7184.59 +/- 1928.18, intake period week 4: 6043.15 +/- 2433.71; P = 0.019). On the other hand, there was no statistically significant in the 5A group. Comparison of the PL and 5A groups at each measurement point showed that the Active Time value was statistically significantly lower in the 5A group than in the PL group at the screening period (P = 0.040). (3) Average Stress Level The PL group showed a significant decrease in Average Stress Level at the 1st, 2nd, and 4th week of intake compared to the screening period (screening period: 34.70 +/- 15.28; intake period, 1st week: 26.88 +/- 9.37; P = 0.041; intake period, 2nd week: 26.07 +/- 8.66; intake period, 4th week: 27.88 +/- 7.35; P = 0.033). 8.66; P = 0.041, intake period week 4: 27.88 +/- 7.35; P = 0.033). On the other hand, there was no statistically significant in the 5A group. There was no statistically significant difference between the PL and 5A groups at each measurement point. (4) rest Stress (sec/day) In the PL group, the rest stress value was significantly increased at week 3 of the intake period compared to the screening period (screening period: 16426.75 +/- 77771.20, intake period week 3: 20097.86 +/- 4562.86; P = 0.039) On the other hand,5A group showed a significant increase in rest stress levels in the first and second week of intake compared to the screening period (screening period: 16267.33 +/- 9961.02, intake period 1: 20183.24 +/- 7361.57; P = 0.023, intake period 2: 21036.98 +/- 7212.41; P = 0.042). 21036.98 +/- 7212.41; P = 0.042). There was no statistically significant difference between the PL and 5A groups at each measurement point. (5) low Stress (sec/day) There was no statistically significant difference in the PL group. On the other hand, the 5A group showed a significant increase in low stress value in the 3rd and 4th week of intake compared to the screening period (screening period: 4409.59 +/- 2543.93, intake period 3rd week: 6731.50 +/- 3237.96; P = 0.009, intake period 4th week: 5660.27 +/- 3065. 34; P = 0.046). There was no statistically significant difference between the PL and 5A groups at each measurement point. (6) high Stress (sec/day) In the PL group, the high Stress value was significantly lower at week 4 of the intake period compared to the screening period (screening period: 4459.68 +/- 4047.07, intake period week 4: 2662.01 +/- 2088.22; P = 0.017). On the other hand, there was no statistically significant variation in the 5A group. There was no statistically significant difference between the PL and 5A groups at each measurement point. (7) deep sleep (sec/day) There was no statistically significant variation in the PL group. On the other hand, the deep sleep value increased significantly in the second and third week of the intake period compared to the screening period (screening period: 5338.19 +/- 3399.32; intake period, second week: 6743.07 +/- 2621.11; P = 0.040; intake period, third week: 6814.64 +/- 2351. 41; P = 0.027). There was no statistically significant difference between the PL and 5A groups at each measurement point. There were no statistically significant changes in average Body Battery, max Stress Level, active Stress (sec/day), medium Stress (sec/day), light Stress (sec/day), rem Stress (sec/day), and awake (sec/day) in both the PL and 5A groups. In addition, there was no statistically significant difference between the PL and 5A groups at each measurement point. 6)Other observations and changes in test items during the study period (1)Oxygen saturation There was no statistically significant variation in both the PL and 5A groups. There was no statistically significant difference between the PL and 5A groups at each measurement point. 7)Exploratory analysis: Changes in VAS values for fatigue and rate of change (Day-0 standard) There was no statistically significant variation from the screening period to the fourth week of the intake period in the PL group. On the other hand, in the 5A group, there was a statistically significant decrease from the screening period to weeks 3 and 4 of the intake period (screening period: 63.52 +/- 11.86, intake period week 4: 57.28 +/- 12.72; P = 0.050, intake period week 4: 54.43 +/- 17.02; P = 0.021). There was no statistically significant difference between the PL and 5A groups at each measurement point.

The safety of the test food (capsules containing 5-ALA/SFC) was confirmed during 28 days of continuous intake. the 5A group showed weekly variations in fatigue and stress before and after intake. In addition, we confirmed that it is possible to obtain useful data for research in a remote environment using electronic logbooks and smartphones.

April. 08, 2022

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https://jrct.niph.go.jp/latest-detail/jRCTs031210123

Nagashima Hirotaka

Tokyo Center Clinic

1-1-8 Yaesu,Chuo-ku,Tokyo

nagashima_hirotaka@tc-clinic.jp

Nagashima Hirotaka

Tokyo Center Clinic

1-1-8 Yaesu,Chuo-ku,Tokyo

+81-3-3276-6935

nagashima_hirotaka@tc-clinic.jp

Complete

May. 31, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Among the sequelae of COVID-19, patients who are at least tired and who meet all of the following selection criteria are targeted.
1) Those who have been diagnosed with a new coronavirus infection within 6 months before obtaining consent
2) Men and women aged 20 to 75 at the time of consent
3) Those who have a feeling of fatigue after COVID-19 infection with VAS of 40 mm or more at Day 0
4) Those who can use smart watches and smartphone applications
5) Those who have voluntarily consented to the document

1) Those who are pregnant or breastfeeding.
Those who do not agree to contraception during the period of participation in this study if the study subject or the research subject's partner may become pregnant.
2) Persons with liver dysfunction
3) Persons with severe anemia
4) Percutaneous arterial oxygen saturation (SpO2)of 94% or less
5) Persons with diseases that are not controlled by treatment with pharmaceuticals, etc.
6) Those who are taking or plan to take supplements other than test foods, foods containing Hypericum erectum, which may affect this clinical study.
7) Those who are currently participating in other intervention clinical studies, or those who have participated in other intervention clinical studies within 3 months before obtaining consent.
8) Persons who are allergic or hypersensitive to 5-ALA and the ingredients contained in this test food, or porphyrins, or who have been confirmed to be intolerant
9) Persons with photosensitivity, persons taking drugs known to cause photosensitivity
10) Persons who have been diagnosed with porphyria or their family members
11) Persons with a history of hemochromatosis or viral hepatitis
12) Those who are allergic to smart watch bands
13)Those who have been vaccinated with the new corona vaccine within 6 months before obtaining
consent
14) Others who are judged by the principal investigator or the investigator to be inappropriate for this study

Both

COVI-19 Sequelae

The subjects of the study were assigned to either the "5-ALA phosphate / SFC-containing capsule intake group" or the "placebo capsule intake group", and in each group, 3 capsules of the test food were administered once a day 2 take once (after breakfast, after dinner) for 28 days.

Frequency of adverse events, illnesses, etc. and side effects

(1) Transition and rate of change of VAS value of fatigue
(2) Transition of answers to the Pittsburgh sleep questionnaire recorded in the electronic diary at the start and end of intake
(3) Changes in the score of COVID-19 sequelae symptoms reported by the study subjects on Day 0
(4) Changes in scores recorded in the electronic diary after evaluating QOL with EQ5D5L
(5) Transition and rate of change of activity, body battery, stress, and sleep analysis results acquired by smart watch
(6) Changes in other observations and inspection items during the test period

+81-3-5366-3006

May. 26, 2021

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