Effect of a Reduced Carbohydrates Menu Combined With a Ketogenic Supplement on Energy Metabolism in a Senior Residence: the SAGE-2 Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Plasma insulin concentration
研究概览
简要总结
The present study will evaluate the effects on glucose, ketones and other blood biomarkers, cognition, quality of life, physical activity and well-being of a reduced carbohydrate diet paired with a ketogenic product for 2 months in a population living in a senior residence. This study follows the KetoHome (fall 2022) and SAGE (fall 2023) projects which assessed the feasibility, acceptability and effectiveness of a reduced carbohydrate intervention alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older men or women in a senior residence;
- •Understand, read and write French;
- •Have sufficient visual and hearing acuity to pass cognitive tests;
- •Available during the intervention period
排除标准
- •Body mass index < 20;
- •T1 diabetic;
- •T2 insulin-dependent diabetic;
- •MMSE < 20;
- •Weight loss >10% in the last 6 months involuntary or voluntary;
- •Known and uncontrolled hypoglycemia;
- •Moderate to severe digestive illnesses that can be aggravated by dietary changes;
- •Severe dysphagia;
- •Supplementation with MCT oil, ketone salts, ketone esters, adherence to the ketogenic diet, reduced carbohydrate diet, intermittent fasting or other diet or supplements that can significantly increase ketones in the last month;
- •Participation in other interventional research projects on nutrition or aimed at metabolic change simultaneously.
- •Medical condition that could prevent the participant from completing the study in the opinion of the doctor
结局指标
主要结局
Plasma insulin concentration
时间窗: 2 months
To evaluate the possible improvement in mean insulin concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
Plasma glucose concentration
时间窗: 2 months
To evaluate the possible improvement in mean glucose concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
Plasma ketones concentration
时间窗: 2 months
To evaluate the possible improvement in mean ketones concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.
次要结局
- Plasma triglycerides concentration(2 months)
- Plasma cholesterol concentration(2 months)