Ketogenic Or LOGI Diet In a Breast Cancer Rehabilitation Intervention (KOLIBRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
The aim of the study is to analyze if a ketogenic diet (KD) compared to either a "low glycämic and insulinemic" (LOGI) diet or to a standard diet (SD) is feasible, safe and tolerable and will improve quality of life and physical performance in patients with Breast Cancer during the rehabilitation phase.
It will be an open-label trial of nutritional intervention for 20 weeks spanning three phases: 3 weeks of stationary intervention, 16 weeks of outhouse phase and one final week of stationary intervention.
详细描述
Cancer patient's whole body metabolism is characterized by an increased fat oxidation rate and a decrease ability to metabolize glucose for energy demands (insulin resistance). In preliminary studies it was shown, that a fat rich diet allows to spare muscle mass from being reduced due to catabolic mechanisms. The resulting better body composition relates to less fatigue and higher quality of life, the latter was shown in advanced cancer patients for a ketogenic diet.
The aim of the KOLIBRI-study is to analyze if a very fat rich ketogenic diet (KD) or a moderate fat rich "low glycämic and insulinemic" (LOGI) diet compared to a standard low fat diet (SD) are feasible, safe and tolerable and will improve quality of life and physical performance in patients with Breast Cancer during the rehabilitation phase.
The most stringent nutritional regime high in fat and low in carbohydrates is the ketogenic diet (KD) comprised of at least 75% of daily calories via fat (derived from several plant oils, nuts, avocado, butter, cream, cheese, eggs, fatty fish and fat rich meat), balanced in protein (1.4 g/kg body weight/day) and very low in carbohydrates (approx. 20-30 grams per day, derived from salad, vegetable, some berries or fruits, and milk products like yoghurt).
A less strict but even lower in carbohydrates and richer in fat and protein than a standard diet is the LOGI regimen. It allows up to 120 grams of carbohydrates (inclusion of more vegetable and fruit and rare grains and potatoes compared to KD), is high in protein (1.7 g/kg body weight/day) and rich in fat (remaining calories) The control nutritional regime follows the standard recommendations of the German society for nutrition (DGE) and is comprised of at least 50% of the daily energy derived from carbohydrates, 0.8 grams/kg of body weight protein and 30% of daily energy expenditure from fat.
It will be an open-label trial of nutritional intervention for 20 weeks spanning three phases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consenting women aged 18 - 70 years.
- •Primary or recurrent breast cancer after primary standard therapy during the standard rehabilitation phase
- •Karnofsky Index >
- •Willing and being able to follow the allocated dietary regime for 20 weeks
排除标准
- •Patients with additional malignant tumors at the time of the recruitment
- •Participation at other trials
- •Dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study
- •Not able to follow the teaching due to deficits in teaching language (German)
- •Metabolic aberration banning fat rich nutrition or were a KD is contraindicated
- •Expected life span < 12 month
- •Insulin dependent Diabetes
- •Decompensated heart failure (NYHA > 2)
- •Myocardial infarction within the last 6 months, symptomatic atrial fibrillation
- •Severe acute infection
- •Pancreatic insufficiency
结局指标
主要结局
Quality of life
时间窗: It will be an open-label trial of nutritional intervention for 20 weeks spanning three phases: 3 weeks of stationary intervention, 16 weeks of outhouse phase and one final week of stationary intervention.
To study the effect of a ketogenic diet (KD) or a low glycämic and insulinemic diet (LOGI) compared to a standard diet (SD) on quality of life in patients with Breast Cancer during the rehabilitation phase. This will be done by comparing the results of the EORTC QLQ-30 and the QLQ-BR23 questionnaires.
次要结局
- Safety(see below (description))
- Tolerability(see below)
研究者
Marc Sütterlin, MD, PhD
MD
Universitätsmedizin Mannheim