Research of new protein drink for effective weight loss
- Conditions
- Obesity disease patients
- Registration Number
- JPRN-jRCTs051200103
- Lead Sponsor
- Takahashi Michiko
- Brief Summary
We conducted a clinical study targeting obese patients, implementing a combination of exercise and dietary therapy, to assess the effectiveness of weight loss through the consumption of soy or whey protein beverages. No significant difference was observed. However, energy, protein and lipid intakes were significantly lower in the soy protein group. Although further investigation is necessary, extending the administration period may result in significant weight loss.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 44
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight loss rate
- Secondary Outcome Measures
Name Time Method