Safety and Tolerability of Soy Fiber in the Elderly: A Dose Escalation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- 10 g Soy-related Stool Frequency
研究概览
简要总结
This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.
详细描述
The tolerability to 10 g, 20 g, and 30 g of soy will be tested. At each dose, eight subjects will incorporate the foods containing soy into their usual diet for one week. The tolerability to each dose will be evaluated and fecal short chain fatty acids will be measured as a biomarker of compliance. Subjects who satisfy the eligibility criteria and express willingness to consume the study foods will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (70 - 85 years).
- •Body mass index between 30 and 40 kg/m
- •No evidence of diabetes (fasting blood sugar <126 mg/dL).
- •No evidence of dementia (MMSE score > 25).
- •No evidence of depression. (Geriatric Depression Scale-15 [GDS-15] <
- •Are weight stable (< 3 kg weight change in the past three months).
排除标准
- •Have type 1 or type 2 diabetes currently being treated by medication.
- •Report clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac disease.
- •Are being treated with medications that have a significant effect on insulin resistance, obesity, and metabolic rate, or medications that significantly increase body weight such as antidepressants, second-generation antipsychotics, systemic glucocorticoids, and adrenergic blockers or stimulators (unless the dose and body weight have been stable for six months).
- •Have serum triglyceride concentrations > 400 mg/dl.
- •Clinically significant abnormal laboratory markers (as determined by the medical investigator).
- •Subjects with anticipated surgery during the study period.
- •Subjects with a reported history of substance abuse or alcoholism or significant psychiatric disorder that would interfere with the ability to complete the study.
- •Subjects who are current smokers or have smoked within the previous three months. Smoking is not permitted during the study.
- •Subjects who are unable to provide a baseline blood or fecal sample or if they have any condition that impedes testing of the study hypothesis or makes it unsafe to consume the food being tested in the study (determined by the investigative team).
- •Women on hormone replacement therapy unless weight has been stable over the last six months.
结局指标
主要结局
10 g Soy-related Stool Frequency
时间窗: One week
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
20 g Soy-related Stool Consistency
时间窗: One week
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
20 g Soy-related Gastrointestinal Symptoms
时间窗: One week
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy
时间窗: One week at each dose
Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety
10 g Soy-related Gastrointestinal Symptoms
时间窗: One week
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
30 g Soy-related Gastrointestinal Symptoms
时间窗: One week
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
10 Soy-related Stool Consistency
时间窗: One week
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
30 g Soy-related Stool Consistency
时间窗: One week
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
20 g Soy-related Stool Frequency
时间窗: One week
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
30 g Soy-related Stool Frequency
时间窗: One week
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
次要结局
- 20 g Soy Intake Effect on Fecal Short Chain Fatty Acids(One week)
- 10 g Soy Intake Effect on Fecal Short Chain Fatty Acids(One week)
- 30 g Soy Intake Effect on Fecal Short Chain Fatty Acids(One week)
研究者
Candida Rebello
Assistant Professor
Pennington Biomedical Research Center