JPRN-jRCTs051200103已完成未知
Verification of soy or whey protein combined HMB and synbiotics for weight loss in obesity : A double-blind, randomized, placebo-controlled trial
Takahashi Michiko0 个研究点目标入组 44 人开始时间: 2020年12月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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