Randomized, Double-blind, Placebo-controlled, 2-treatment, 3-period Crossover Design Study of the Efficacy and Tolerability of Psyllium 6.8 g Provided as Sugarfree Metamucil® Fiber Supplement Powder Versus Placebo on Satiety in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- satiety (VAS Hunger 3-day average)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, 2-treatment, 3-period crossover design study to evaluate the effects of psyllium 6.8 g provided as sugarfree Metamucil fiber supplement powder dissolved in water versus placebo on satiety measures in healthy volunteers. This study will be conducted at a single study site.
详细描述
A total of 45 subjects will be enrolled in this study. Approximately equal numbers of men and women will be enrolled, with a race distribution consistent with the US population. Eligible subjects will be randomly assigned to 1 of 2 test product sequences at Test Period 1 (Visit 2) using a block randomization. Subjects will participate in 3 test periods (Test Period 1, Visits 2-4; Test Period 2, Visits 5-7; and Test Period 3, Visits 8-10) and will receive test product once a day before breakfast for 3 days within each period. Test periods will be separated by a minimum 4-day washout period in which no test product will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet all of the following criteria are eligible to participate in the study:
- •routinely eat breakfast daily;
- •agree to eat 100% of the food provided during the study, drink 10 ounces of water with the test product immediately before breakfast, and only eat a light snack after dinner before fasting overnight beginning at 10:00 PM prior to the next visit;
- •have a screening VAS Hunger score > 50 before eating breakfast that moves towards less hunger after eating breakfast;
- •have 1-2 bowel movements per day that are typically rated as 3, 4, or 5 on the Bristol Stool Form Scale;
- •in good general health based on medical history;
- •if female, be postmenopausal or if of child-bearing capacity agree to use an adequate form of contraception (eg, surgical sterilization, birth control pills, birth control implants, condoms AND spermicide, abstinence);
- •have a body mass index (BMI) ≥ 18.5 but < 28 kg/m2;
- •able to fulfill the requirements of the protocol and provide written consent;
- •willing to abstain from any weight control or satiety supplements during the study;
- •willing to refrain from taking any psyllium containing products or fiber supplements during the study with the exception of the test products;
- •willing to maintain lifestyle habits for the duration of the study (eg, do not change exercise habits or begin a weight loss diet);
- •willing to refrain from exercise on the mornings prior to arriving at the study site;
- •willing to abstain from alcohol for 2 days prior to the first day of each test period through the last day of each test period;
- •willing not to consume caffeine for 24 hours prior to the first day of each test period through the last day of each test period.
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •have any history of heart, liver, kidney, nerve, blood disorder, or cancer(except for treated basal cell cancer with a documented 6-month remission), or metabolic, hormone, or gastrointestinal (GI) disease;
- •have a history of an eating disorder;
- •have difficulty swallowing;
- •have a history of gastrointestinal surgery (except appendectomy) or gastrointestinal bleeding;
- •are currently alcohol or chemically dependent (a urine test for drugs of abuse will be given);
- •report use of tobacco, smoking cessation products, or products containing nicotine within 3 months;
- •have a significant psychiatric disorder;
- •any use of prescription drugs, with the exception of birth control pills, within 14 days prior to the study or antibiotics in the past 30 days;
- •any use of non-prescription drugs within 7 days prior to the study;
- •used psyllium containing products or fiber supplements within the past month;
- •have a history of phenylketonuria (PKU);
- •have a history of a severe allergic reaction to psyllium;
- •are currently on a structured formal diet (eg, Jenny Craig, Atkins);
- •typically drink more than 70 ounces of liquid during the day (ie, approximately 4 bottles of water, each 16.9 ounces)
- •have a history or presence, upon clinical evaluation, of any illness or condition that might impact the safety of the study product;
- •participated in a clinical drug study or used an investigational new drug within 30 days of dosing;
- •pregnant or nursing, if female;
- •engage in excessive exercise that is extreme in frequency or duration;
- •find the study meals unpalatable
结局指标
主要结局
satiety (VAS Hunger 3-day average)
时间窗: Hours 0-4.5
VAS Hunger 3-day average. This endpoint will be calculated by averaging all evaluable post-breakfast scores across Days 1, 2, and 3. VAS Hunger is assessed on a horizontal 100-mm VAS anchored on the left by the phrase "Not at all hungry" (score = 0) and on the right by "As hungry as I have ever felt" (score = 100).
次要结局
- Satiety Labeled Intensity Magnitude (SLIM) 3-day average(Hours 0-4.5)
- VAS Desire to Eat 3-day average(Hours 0-4.5)
- VAS Hunger 3-day average for hours 3.0 - 4.5(Hours 3.0 - 4.5)
- SLIM 3-day average for Hours 3.0-4.5(Hours 3.0-4.5)
- VAS Desire to Eat 3-day average for hours 3.0 - 4.5(Hours 3.0-4.5)