NCT06521424已完成不适用
The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Active Adults
Athletic Greens International2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月1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
- 20
- 试验地点
- 2
- 主要终点
- Nutrient Gaps
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled study of N=20 active men and women. This study to assess the effect of a novel dietary supplement on improving nutrient gaps and the gut microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 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.
- •> 1 year of resistance training experience (minimum of 2 days per week of resistance training session with free weights)
- •Age between 18 and 40 yr (inclusive).
- •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.
- •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
Nutrient Gaps
时间窗: 14 days
Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
Gut Microbiome
时间窗: 14 days
Examine changes in the gut microbiome via fecal polar metabolomics measured by LC/MS
次要结局
- Exploratory Digestive Measures(14 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Adults With Occasional Gastrointestinal IssuesNCT06564285Athletic Greens International24
已完成
不适用
The Effects of a Novel Nutritional Product on Nutrient Status and Digestive HealthGastrointestinal MicrobiomeNutrition, HealthyHealthy AgingNCT06181214Athletic Greens International30
已完成
不适用
The Effects of a Nutritional Supplement on Nutrient Status and Quality of LifeNutrition, HealthyGastrointestinal MicrobiomeHealthy AgingNCT06332898Athletic Greens International105
已完成
不适用
A Pharmacokinetic Study of a Novel Nutritional Product on Healthy Men and WomenHealthy AgingNCT06316700Athletic Greens International16
已完成
3 期
Effect of B-GOS on GI Discomfort in Healthy AdultsHealthyNCT01824667Clasado Limited400