Tolerability and Feasibility Evaluation of a Food Additive Based on Porous Silica Compounds for Future Weight Loss and Prevention of Obesity Related Co-morbidities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Adverse events
研究概览
简要总结
The aim of the present study was to determine whether oral dosing, up to 9 grams/day, of porous silica administered as a food additive can be used safely in normal weight and obese male humans, without significant side effects on gastrointestinal function, bowel emptying habits, and biomarkers.
详细描述
This single blinded safety study will consist of two study arms and include 10 males each (18-35 years). One arm will include participants with normal weight and one with obesity. After a placebo run-in period, all subjects will be given porous silica three times daily, with increasing dose up to 9 grams/day (Phase 1). Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2).
The participants will have weekly contacts during with the representative for the study (PI or other research staff). Clinical examinations, and blood sampling will be performed day 1, 7, 14, and 21. Faeces and morning urinary sampling day 1, and 21. Information regarding eating habits, sleep patterns, living conditions and gastrointestinal health were obtained from written forms and orally. If gastrointestinal adverse events would occur after increased dosage, the study staff will adapt the dosage protocol to facilitate adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Group - Normal weight subjects
- •Age 18-35
- •BMI 20-25
- •Group - Subject with obesity
- •Age 18-35
- •BMI 30-45
排除标准
- •Chronic somatic diseases that may affect metabolic and/or intestinal function (e.g. diabetes, hypertension, dyslipidemia, Irritable Bowel Disease, gluten intolerance, pancreatic dysfunction, other causes of malabsorption, neoplastic disease,)
- •Allergies with previous anaphylactic reactions
- •Previous abdominal surgery
- •Current or history of eating disorders
- •Extreme or unusual diets such as Low Carb High Fat and vegetarian diets for the last year
- •Psychiatric disorders (e.g. schizophrenia, and other diagnoses that may influence compliance)
- •Drug or alcohol abuse
- •Continuous oral pharmacological treatment and other types of pharmacological treatment that may influence the study
- •Other conditions which the investigator considers could negatively affect the outcome of the study or study compliance
研究组 & 干预措施
Normal weight subjects
Healthy normal weight (BMI 20-25) men 18-35 year. Intervention: The participants will take placebo or silica powder with specified doses administrated in vials and with instructions to mix with water as; Placebo (microcrystalline cellulose) day 1-5 Porous silica 1gx3 daily for day 6-9 Porous silica 2gx3 daily for day 10-14 Porous silica 3gx3 daily for day 15-21 Total study time 21 days
干预措施: Porous silica (Dietary Supplement)
Normal weight subjects
Healthy normal weight (BMI 20-25) men 18-35 year. Intervention: The participants will take placebo or silica powder with specified doses administrated in vials and with instructions to mix with water as; Placebo (microcrystalline cellulose) day 1-5 Porous silica 1gx3 daily for day 6-9 Porous silica 2gx3 daily for day 10-14 Porous silica 3gx3 daily for day 15-21 Total study time 21 days
干预措施: Placebo (microcrystalline cellulose) (Dietary Supplement)
Subjects with obesity
Obese otherwise healthy men (BMI 30-45) 18-35 year Intervention: The participants will take placebo or silica powder with specified doses administrated in vials and with instructions to mix with water as; Placebo (microcrystalline cellulose) day 1-5 Porous silica 1gx3 daily for day 6-9 Porous silica 2gx3 daily for day 10-14 Porous silica 3gx3 daily for day 15-21 The dose of Silica 3gx3 for additional 10 weeks Total study time 84 days
干预措施: Porous silica (Dietary Supplement)
Subjects with obesity
Obese otherwise healthy men (BMI 30-45) 18-35 year Intervention: The participants will take placebo or silica powder with specified doses administrated in vials and with instructions to mix with water as; Placebo (microcrystalline cellulose) day 1-5 Porous silica 1gx3 daily for day 6-9 Porous silica 2gx3 daily for day 10-14 Porous silica 3gx3 daily for day 15-21 The dose of Silica 3gx3 for additional 10 weeks Total study time 84 days
干预措施: Placebo (microcrystalline cellulose) (Dietary Supplement)
结局指标
主要结局
Adverse events
时间窗: From start of intervention up to 12 weeks
According to MedDRA SOC.
次要结局
- Body weight(From start of intervention up to 12 weeks)
- Change in systemic inflammation status(From start of intervention up to 12 weeks)
- Number of participants with affected gastrointestinal function(From start of intervention up to 12 weeks)
- Change in glucose metabolism(From start of intervention up to 12 weeks)
- Change in renal status measured by creatinine(From start of intervention up to 12 weeks)
- Change in renal status measured by glomerular filtration rate(From start of intervention up to 12 weeks)
- Change in renal status measured by cystatin C(From start of intervention up to 12 weeks)
- Change in nutrition status(From start of intervention up to 12 weeks)
- Presence of fecal abnormalities(From start of intervention up to 12 weeks)
- Change in lipid profile(From start of intervention up to 12 weeks)
- Change in concentration of silica(From start of intervention up to 12 weeks)
- Change in blood pressure(From start of intervention up to 12 weeks)
- Change in liver status(From start of intervention up to 12 weeks)
研究者
Pernilla Danielsson
Principal Investigator
Karolinska Institutet