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The effects of consuming food containing SACS10 on the serum lipid: an open-label study

The effects of consuming food containing SACS10 on the serum lipid

Takara Tsuyoshi

Medical Corporation Seishinkai, Takara Clinic

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo

t-takara@takara-clinic.com

Suzuki Naoko

ORTHOMEDICO Inc.

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo

+81-3-3813-5106

group_gakujutsu@orthomedico.jp

Complete

Sept. 16, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects whose BMI is 25 kg/m^2 or more and less than 30 kg/m^2
6. Subjects whose LDL-cholesterol level is 159 mg/dL or higher and is relatively high among study participants at screening (before consumption)
7. Subjects who are judged as eligible to participate in the study by the physician

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}
5. Subjects who regularly exercises at least 6.0 METs (high intensity weight training, shortness of breath exercises, sports)
6. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift
7. Subjects who have irregular lifestyles (such as inconstant eating time, insufficient sleeping time)
8. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
9. Subjects who are currently taking medications (including herbal medicines) and supplements
10. Subjects who are allergic to medicines and/or the test food related products
11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
12. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
13. Subjects who are judged as ineligible to participate in this study by the physician

Both

Healthy subjects (Intended indications and effects: Improvement in the blood lipid)

Test food: SACS10-containing soft capsule
Duration: 12 weeks
Administration: Take two capsules per day with water once daily.

Total cholesterol (T-Cho), HDL-cholesterol (HDL-Cho), LDL-cholesterol (LDL-Cho), and triglyceride (TG) at 12 weeks after consumption (12w)

1. Glucose (GLU), hemoglobin A1c (HbA1c: NGSP), pentosidine, carboxymethyllysine (CML), malondialdehyde (MDA), total abdominal fat area, abdominal visceral fat area, abdominal subcutaneous fat area, body weight, body mass index (BMI), body fat percentage, skeletal muscle mass, 8-hydroxy-2'-deoxyguanosine (8-OHdG) in the urine, each score {Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F)} in the Profile of Mood States 2nd Edition (POMS2), each score ("sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," and "sleep length") in the OSA sleep inventory MA version (OSA-MA), and fatigue measured by visual analogue scale (VAS) at 12w
2. Each item in the POMS2 and the OSA-MA at 12w

+81-3-5793-3623

Aug. 23, 2023

No

None