Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Change in Glycated Hemoglobin
研究概览
简要总结
The goal of this clinical trial is to examine the effect plant-based diet, with a partial replacement of animal protein by plant protein, in blood sugar levels and other health risks of people with type 2 diabetes and excessive weight. The plant-based diet will be compared to a standard healthy diet according to guidelines for people with diabetes. Participants will follow a plant-based or a standard healthy diet for 24 weeks and will maintain their habitual levels of physical activity.
详细描述
This is a single center, open label, parallel and randomized clinical trial. Subjects with type 2 diabetes (T2D) and excessive weight will be recruited through advertisement on the web page of Hospital de Clínicas de Porto Alegre (HCPA), local newspaper, television and social media, or referred by a doctor or nutritionist, from external to HCPA services. Patients will be also screened through electronic records of HCPA's clinics. After screening and selection according to inclusion criteria, participants will undergo a clinical, laboratory and nutritional evaluation following a standard assessment protocol. After all baseline assessments, they will be randomly allocated to one of the following interventions for 24 weeks: (1) Control diet (CDG): hypocaloric diet according to current guidelines for T2D or (2) Plant-based diet (PBG): hypocaloric diet with partial replacement of animal protein by plant protein. Both groups will have caloric targets calculated to achieve a 5% weight loss during the 6 months of study, will have the same macronutrient distribution on the diet and will receive the same nutritional and medical support. Telephone calls will be performed monthly for adherence evaluation. At the end of 12 and 24 weeks of intervention, all patients will be submitted to the same clinical, laboratory and nutrition exams applied at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The participants and the care providers will not be blinded. People involved in assessing outcomes and with data analysis will be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 and ≤65 years old)
- •Diagnosis of Type 2 Diabetes;
- •Glycated hemoglobin from 7% to 11%;
- •Overweight or obesity (BMI ≥25 kg/m² and <40 kg/m²);
- •Use of any hypoglycemic and insulin;
- •Stable weight (maximum variation of approximately 5%) for at least 12 weeks before screening;
- •Not having undergone dietary intervention in the last 6 months;
- •Have the ability to understand and be able to adhere to intervention proposals;
- •Able and willing to provide an informed consent form for written and to comply with the requirements of the study protocol;
排除标准
- •Type 1 diabetes mellitus;
- •Retinopathy with vision deficit that limits the activities proposed in the interventions;
- •Chronic kidney disease with estimated glomerular filtration < 30 mL/min per 1.73m²;
- •Liver failure, chronic viral hepatitis;
- •Grade III or IV heart failure
- •Active or progressive neurodegenerative disease;
- •Prior stroke that has caused sequelae;
- •Use of medications that affect glucose metabolism (e.g. corticosteroids or immunosuppressants) or cause weight loss;
- •Chronic treatment with oral or parenteral corticosteroids (>7 days consecutive treatment) within 4 weeks prior to screening;
- •Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion, liraglutide, semaglutide) within the last 12 weeks before screening;
- •Treatment with thyroid hormone that was not maintained at a stable dose in last 12 weeks before screening;
- •History of active substance abuse (including alcohol) within the last year;
- •Thyroid Stimulating Hormone (TSH) outside the normal range;
- •Fasting triglycerides ≥ 600 mg/dL;
- •Tumor diagnosed and/or treated (except basal cell skin cancer, carcinoma in situ of the cervix, or prostate cancer in situ) within the last 5 years;
- •Severe psychiatric illness;
- •Predisposition or diagnosis of eating disorders;
- •Women who are pregnant, intend to become pregnant during the study period, or who are currently breastfeeding;
- •Hyperglycemia characterized by acute symptoms: polyuria, polydipsia and/or weight loss in the last 3 months;
- •Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma;
- •Potentially unreliable patients and those deemed by the investigator to be unsuitable for the study;
- •Night workers who work after 10pm;
- •Being on a vegetarian, vegan or flexitarian diet at the time of recruitment;
- •Having undergone bariatric surgery;
- •Carriers of the human immunodeficiency virus (HIV);
- •Any other medical condition/disorder that the investigators consider that are likely to: interfere with the patient's ability to complete the entire study period or participate in study activities;
- •Participants who require any treatment that could affect the interpretation, reliability or safety of data during the study intervention.
研究组 & 干预措施
Control
Hypocaloric diet with predominance of animal protein
干预措施: Control Diet (Behavioral)
Intervention
Hypocaloric diet with predominance of plant protein
干预措施: Plant-based Diet (Behavioral)
结局指标
主要结局
Change in Glycated Hemoglobin
时间窗: baseline, 12 and 24 weeks
Difference between groups in glycated hemoglobin
次要结局
- Glycemic Variability(baseline and 12 weeks)
- Changes in postprandial metabolism(baseline and 12 weeks)
- Changes in body composition(Monthly, up to 24 weeks)
- Changes in cardiometabolic outcomes(baseline and 24 weeks)
- Changes in depressive symptoms(baseline, 12 and 24 weeks)
- Changes in blood pressure(baseline, 12 and 24 weeks)
- Changes in inflammatory marker(baseline and 24 weeks)
- Changes in food craving scale(baseline, 12 and 24 weeks)
- Changes in quality of life scale(baseline, 12 and 24 weeks)
- Changes in anxiety symptoms(baseline, 12 and 24 weeks)
- Adherence to a plant-based diet(Baseline, 12 and 24 weeks)
- Incidence of sarcopenia(baseline, 12 and 24 weeks)
- Change in ultra-processed food consumption(Baseline, 12, and 24 weeks)
- Change in estimated glomerular filtration rate(Baseline and 24 weeks)
- Change in albuminuria(Baseline, 12 and 24 weeks)
- Change in bone mineral metabolism parameters(Baseline, 12 and 24 weeks)