A Randomized, Triple-blind, Placebo-controlled, Cross-over Study to Evaluate Acute and Short-term Efficacy of Digest Gold on Postprandial Abdominal Distension and Subjective Bloating in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- The difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 - 120 minutes postprandial)
研究概览
简要总结
The goal of this clinical trial is to investigate the acute and short-term efficacy of Digest Gold on postprandial abdominal distension and subjective bloating in healthy adults. The main question it aims to answer is what is the difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 -120 minutes postprandial), as assessed by the bloating Likert scale?Researchers will compare Digest Gold to a placebo to see its effects on postprandial abdominal distension and bloating. Participants will:
- Consume Digest Gold and a placebo.
- Have height, weight, and waist circumference measured.
- Have blood pressure and heart rate measured.
- Provide blood samples.
- Provide a fecal sample.
- Complete study questionnaires assessing gastrointestinal symptoms and subjective bloating.
- Record their daily food intake.
- Complete a breath test to assess gastrointestinal parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 18 years and older
- •Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- •Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •Abstinence and agrees to use contraception if planning on becoming sexually active during the study
- •Self-reported post-meal bloating or abdominal distension at least one day per week AND confirmation of a history of bloating or abdominal distension following consumption of meals similar to the study-specific standardized meal
- •Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
- •Agrees to avoid moderate-vigorous exercise (cardio or strength training) or strenuous physical activity 12 hours prior to clinic visits
- •Agrees to avoid nonsteroidal anti-inflammatory drugs (NSAIDs) 24 hours prior to clinic visits (Section 7.3.2)
- •Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- •Provided voluntary, written, informed consent to participate in the study
- •Healthy as determined by medical history and laboratory results as assessed by the Medical Doctor (MD)
排除标准
- •Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- •Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product (IP), placebo, or standardized meal ingredients (e.g., gluten intolerance)
- •Current or history of any significant diseases of the gastrointestinal tract or digestive disorders (e.g., celiac disease, inflammatory bowel disease, functional constipation, unstable gastroesophageal reflux disease, unstable gallstones), as assessed by the MD
- •Colonoscopy within 14 days of baseline or scheduled colonoscopy during the study period
- •Unstable metabolic disease or chronic diseases as assessed by the MD
- •Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the MD (See Section 7.3)
- •Type I or Type II diabetes
- •Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the MD on a case by-case basis
- •History of or current diagnosis with kidney and/or liver diseases as assessed by the MD on a case by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- •Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the MD
- •Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the MD
- •Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- •Individuals with an autoimmune disease or are immune compromised as assessed by the MD
- •Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the MD
- •Self-reported confirmation of blood/bleeding disorders as assessed by the MD
- •Use of prescribed medical cannabinoid products
- •Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- •Regular use of tobacco or nicotine products in the past six months, as assessed by the MD. Occasional users will be required to washout and abstain for the duration of the study period
- •Alcohol intake average of >2 standard drinks per day as assessed by the MD
- •Alcohol or drug abuse within the last 12 months
- •Current use of prescribed and/or Over-the-Counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
- •Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- •Participation in other clinical research studies 30 days prior to baseline, as assessed by the MD
- •Individuals who are unable to give informed consent
- •Any other condition or lifestyle factor, that, in the opinion of the MD, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
研究组 & 干预措施
Digest Gold
At Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2.
干预措施: Digest Gold (Dietary Supplement)
Placebo
At Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
The difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 - 120 minutes postprandial)
时间窗: Day 1
The difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 - 120 minutes postprandial), as assessed by the bloating Likert scale. A four-point Likert scale (absent - 0, mild - 1, moderate - 2, or severe - 3) will be used to measure gas and bloating. A higher score means more severe bloating.
次要结局
- The difference in change between Digest Gold and placebo in abdominal distension(Pre-dose to time = 15, 30, 60, and 120 minutes postprandial at Day 1)
- The difference in change between Digest Gold and placebo in subjective bloating(Pre-dose to time = 15, 30, 60, and 120 minutes postprandial at Day 1)
- The difference in postprandial waist circumference area under the curve (AUC₀-₁₂₀ minutes) between Digest Gold and placebo(Day 1)
- The difference in maximum postprandial change in waist circumference from the pre-meal measurement between Digest Gold and placebo at Day 1.(Day 1)
- The difference in change in breath methane and hydrogen between Digest Gold and placebo(Pre-dose to time = 60 and 120 minutes postprandial at Day 1)
- The difference in postprandial breath methane and hydrogen area under the curve (AUC₀-₁₂₀ minutes) at Day 1 between Digest Gold and placebo(Day 1)
- The difference between Digest Gold and placebo in time-to-relief of subjective gas(Day 1)
- The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60 and 120 minutes postprandial at Day 1 in glucose(Day 1)
- The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60 and 120 minutes postprandial at Day 1 in insulin(Day 1)
- The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60 and 120 minutes postprandial at Day 1 in triglycerides(Day 1)
- The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60 and 120 minutes postprandial at Day 1 in total amino acids(Day 1)
- The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in abdominal distension(Day 1 to Day 7)
- The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in breath methane and hydrogen(Day 1 to Day 7)
- The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in Gastrointestinal symptoms(Day 1 to Day 7)
- The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in gas and bloating(Day 1 to Day 7)
- The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in quality of life(Day 1 to Day 7)
- The difference between Digest Gold and placebo in the daily postprandial area under the curve (AUC) during the supplementation period (Day 1 to 6) for abdominal distension(Day 1 to Day 6)
- The difference between Digest Gold and placebo in the daily postprandial area under the curve (AUC) during the supplementation period (Day 1 to 6) for breath methane and hydrogen(Day 1 to Day 6)