Intervention study to verify the effect of the changes in intestinal bacteria by intake of tea catechin and inulin on visceral fat reduction

JRCT ID: jRCTs021230004

Registered date:16/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Visceral fat obese
• Date of first enrollment: 16/05/2023
• Target sample size: 114
• Study type: Interventional

Intervention(s)

arm 1: Test foods (tea catechin-containing powdered beverage and inulin-containing powdered drink) are ingested once a day for 12 weeks
arm 2:Control foods (placebo powdered drink) are ingested once a day for 12 weeks

Outcome(s)

• Primary Outcome: Change in the abdominal visceral fat area

Secondary Outcome

1. Changes in the intestinal flora
2. Changes in the waist circumference
3. Changes in the body weight
4. Change in the BMI
5. Change in the body fat ratio
6. Changes in the glucose metabolism-related measurements (Glu, HbA1c, insulin, glycoalbumin)
7. Changes in the lipid metabolism-related measurements (TG, HDL-C, LDL-C)
8. Changes in the blood biochemical test measurements (TP, ALB, GOT, GPT, gamma-GTP, UA, BUN, Cre, CRP, VB12) other than the glucose metabolism-related measurements and the lipid metabolism-related measurements
9. Changes in the hematology test measurements (WBC, RBC, HB, HT, PLT, MCV, MCH, MCHC)
10.Changes in the physiological test measurements (systolic blood pressure, diastolic blood pressure, pulse rate)
11. Changes in the liver fat mass
12.Relationship with the questionnaire items (35 items on dietary habits, FFQ, intestinal regulation related indicators)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Those who are participants in the 2023 Iwaki Health Promotion Project Medical Checkup and meet the following inclusion criteria.
-Inclusin criteria-
1. Men and women who are 20 years old or over and under 75 years of age
2. Those with BMI of 23 kg/m2 or more
3. Those with visceral fat area of 80 cm2 or more

Exclude criteria

1. Those who with hepatic, renal, heart disease, respiratory disorders, digestive disorders, endocrine disorders, metabolic disorders, neuropathy, consciousness disorders, diabetes, hyperlipidemia, hypertension, or other diseases and who are receiving medication treatment and are judged to be inappropriate by a doctor.
2. Those who take diabetes medications such as alpha-glucosidase inhibitors or biguanides that may affect the gut microbiota.
3. Pregnant women (those who plan to become pregnant)
4. Those who work night shifts at least once a week
5. Those who have a history of gastrointestinal resection (excluding appendectomy)
6. Those who have positive HBs antigen markers
7. Those who have positive HCV antibody markers
8. Those who have food allergies
9. Those who are allergic to metal (stainless steel) or have a pacemaker in their body
10. Those who have a history of malignant tumors
11. Those who have a history of mental illness
12. Those who have changes more than 2 kg of weight within 3 months of the start of this study
13. Those who regularly use pharmaceuticals, etc. that may affect the present study
14. Those who donated 200 mL or more of blood within one month of the start of the study, or those who plan to do so during the research period.
15. Those who cannot measure with a visceral fat measuring device
16. Other persons who are judged inappropriate by the principal investigator or the co-investigator

Related Information

• Primary Sponsor: Mikami Tatsuya
• Secondary Sponsor: Health & Wellness Products Research