NL-OMON40400已完成2 期
Protein and lifestyle intervention to preserve muscle mass in obese older type 2 diabetes patients - a 13-week randomised, controlled exploratory study with a 24-week follow-up period. - PROBE
utricia0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age 55-85 years old, inclusive
- •2. Ambulant type 2 diabetes patients (verified by used medication for Diabetes). In the event no medication is used HbA1c should be > 53 mmol/mol (>7.0 %)
- •3. - BMI > 30 kg/m2 or
- •- BMI >27 kg/m2 in combination with a waist circumference > 88 cm for women and > 102 cm for men
- •4. Willingness that general practitioner will be notified on study participation
- •5. Written informed consent
- •6. Willingness and ability to comply with the protocol
- •7. Ability to comply with the exercise protocol as assessed by a sports physician.
排除标准
- •1. Specific medical history: any malignant disease during the last five years except for adequately treated prostate cancer without evidence of metastases, localized bladder cancer, cervical carcinoma in situ, breast cancer in situ and non-melanoma skin cancer, and other relevant medical history that could affect the study outcome as judged by the study physician.
- •2. Any gastrointestinal disease that interferes with bowel function and nutritional intake (e.g. constipation or diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis, (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding).
- •3. Wearing an electronic implant and /or pacemaker
- •4. Renal disease (estimated Glomerular Filtration Rate [eGFR] <60 mL/min as based on MDRD formula)
- •5. Hepatic disease (liver enzymes ALAT, ASAT, GGT or ALP greater than 3 times Upper Limit of Normal)
- •6. Use within 2 weeks prior to baseline and/or expected use during the study of:
- •- Corticosteroids for systemic use
- •- Antibiotics for systemic use
- •7. Use of insulin
- •8. Change in dose within three months prior to baseline of:
- •- Antidepressants
- •- Neuroleptics
- •- Lipid lowering medication
- •9. Specific dietary and/or lifestyle factors present within three months prior to baseline:
- •- Involuntary weight loss of at least 5%.
- •- Use of protein containing or amino acid containing nutritional supplements
- •10. Known allergy to cow*s milk and milk products or the ingredients of the study products
- •11. Known galactosaemia
- •12. Known lactose intolerance
- •13. More than 22 µg (880 IU) of daily Vitamin D intake from non-food sources (such as supplements and prescribed medication)
- •14. More than 500 mg of daily calcium intake from non-food sources (such as supplements and prescribed medication)
研究者
相似试验
已完成
不适用
Improvements by a Protein-rich Plant-based Diet and Resistance Exercise Program for Active AgeingProtein IntakeNCT06172725Amsterdam University of Applied Sciences110
已完成
不适用
PULSE, A protein feeding strategy to promote muscle protein anabolism in the elderlyNL-OMON32866TIF24
已完成
不适用
Dietary strategies to promote muscle protein anabolism in the elderlypreventie sarcopenieloss of muscle masssarcopenia10028302NL-OMON31675niversiteit Maastricht132
已完成
不适用
Protein and lifestyle intervention to preserve muscle mass in obese older type 2 diabetes patients – a 13-week randomised, controlled exploratory study with a 24-week follow-up period.NL-OMON21917utricia Research BV120
进行中（未招募）
2 期
Optimising micronutrient status in toddlers - putting the theory into practiceMicronutrient status of toddlersDiet and Nutrition - Other diet and nutrition disordersACTRN12605000487617niversity of Otago225