NCT06181214已完成不适用
The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health
Athletic Greens International2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gut Microbiome
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled study of N=30 apparently healthy men and women. This is an exploratory study to assess the effect of a novel dietary supplement on blood markers of nutrient status and the gut microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide voluntary signed and dated informed consent.
- •Be in good health as determined by medical history and routine blood chemistries.
- •Age between 18 and 50 yr (inclusive).
- •Body Mass Index of 18.5-29.9 (inclusive).
- •Body weight of at least 120 pounds.
- •Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- •Normal seated, resting heart rate (<90 per minute).
- •Willing to duplicate their previous 24-hour diet, refrain from caffeine and exercise for 24 hours prior to each visit, and fast for 10 hours prior to each visit.
- •Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
- •Subject is willing and able to comply with the study protocol.
排除标准
- •History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
- •History of diabetes or endocrine disorder.
- •History of use of medications or dietary supplements known to confound the study or its endpoints.
- •Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
- •Current smokers or smoking within the past month.
- •History of hyperparathyroidism or an untreated thyroid condition.
- •History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- •Prior gastrointestinal bypass surgery (Lapband), etc.
- •Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, Irritable bowel syndrome (IBS), diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
- •Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- •Previous medical diagnosis of asthma, gout, or fibromyalgia.
- •Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to take a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent.
- •Known sensitivity to any ingredient in the test formulations as listed in the product label.
- •Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- •Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
结局指标
主要结局
Gut Microbiome
时间窗: 28 days
Examine changes in the gut microbiome structure and function measured by shallow shotgun metagenomics. Examine enrichment of taxa and metabolic pathways in the gut microbiome as a result of dietary supplementation.
次要结局
- Exploratory Digestive Measures(28 days)
- Complete Blood Count(28 Days)
- Exploratory nutrient status markers(28 days)
- Exploratory Stool Consistency(28 days)
- Complete Metabolic Blood Panel(28 Days)
- Exploratory Stool Frequency(28 days)
研究者
研究点 (2)
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