Research of new protein drink for effective weight loss

JRCT ID: jRCTs051200103

Registered date:22/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obesity disease patients
• Date of first enrollment: 31/03/2021
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Orally administer allocated soy or whey protein or placebo once a day for 12 weeks

Outcome(s)

• Primary Outcome: Weight loss rate

Secondary Outcome

Changes in body weight and Waist circumference from the start of the study drug administration, and at 4, 8 and 12 weeks after the start of administration
The amount of change in muscle mass after the start of administration of the study drug by BIA method at 4 weeks, 8 weeks and 12 weeks and DXA method at 12 weeks after the start of administration
Change rate of muscle mass after the start of administration of the study drug by BIA method at 4 weeks, 8 weeks and 12 weeks and DXA method at 12 weeks after the start of administration
The amount of change in body fat mass after the start of administration of the study drug by BIA method at 4 weeks, 8 weeks and 12 weeks and DXA method at 12 weeks after the start of administration
Change rate of body fat mass after the start of administration of the study drug by BIA method at 4 weeks, 8 weeks and 12 weeks and DXA method at 12 weeks after the start of administration
Change rate of bone mineral content by DXA method 12 weeks after the start of administration of the study drug
Rate of change in basal metabolic rate measured in an indirect calorimeter 12 weeks after the start of administration of the study drug
Systolic and diastolic blood pressure at 4 weeks, 8 weeks and 12 weeks after the start of administration
Levels of glucose, lipid and uric acid metabolisms ( HbA1c, GA , BG , TG , HDL , LDL , UA ) from before the start of administration of the study drug, and at 4, 8 and 12 weeks after the start of administration
Levels of 75g OGTT from before the administration of the study drug to 12 weeks after the administration
Change in serum adipokine ( Adiponectin, leptin and chemerin ) from 12 weeks after the start of study drug administration
Change in lipid mediators 12 weeks after the start of administration of the study drug
Presence or absence of renal disorder
Presence or absence of disease

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Obese patients who meet any of the following criteria
i Persons with BMI of 30 kg / m2 or more
ii Persons with BMI of 25 kg / m2 or more with diabetes or dyslipidemia
2. Any gender, age: 18 years old or older when consent is obtained
3. Patients who have been diagnosed with diabetes, who are receiving stable treatment with diet and exercise therapy alone, or with antidiabetic drugs, and have HbA1c less than 8.0 g / dl ( Stable with the same drug, dosage and administration for 30 days or more before obtaining consent )
4. Patients who have given their free written consent to participate in this clinical study. 4. Patients who have given their free written consent to participate in this clinical study. However, the subjects who are 18 years old or older and younger than 20 years old are those who have obtained the consent of their delegate.

Exclude criteria

1. Patients participating in other clinical trials
2. Patients who are allergic to soybeans or whey proteins
3. Renal failure patients with CKD stage G3 or higher
4. Patients with severe liver disorder associated with hepatic encephalopathy
5. Patients who have been treated with any drug indicated for obesity disease within 30 days before registration date.
6. Patients who have a weight change of 5 kg or more within 30 days before the consent acquisition date.
7. Patients who have been treated with bariatric surgery or medical devices for weight loss in the past or scheduled to undergo during the study period
8. Patients with uncontrolled thyroid disease
9. Female patients who are pregnant, breastfeeding, wishing to become pregnant within the study period, or who are unable to accept a contraceptive method that is fertile and highly effective
10.Patients with cardiac pacemaker implantation
11.Patients who are judged to be unsuitable for this clinical study by the responsible physician/sharing physician

Related Information

• Primary Sponsor: Takahashi Michiko