A Comparison of the Metabolic Effects of Zinc-Amino Acid (ZnAA) Versus Zinc Gluconate Given in a Fasted State
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- FADS1 activity index
研究概览
简要总结
Food consumption affects zinc metabolism within the body. Lowe and colleagues demonstrated that zinc is directed out of plasma and into tissues, such as into the liver, postprandially . It is likely that zinc absorbed with a meal is directed to the liver via the portal circulation whereas that zinc taken in the fasted state is more readily directed to peripheral blood plasma. Zinc taken with food is more likely to be bound to components of the food matrix and, therefore, it is not absorbed as efficiently by Zip4 ionic zinc transporters in the upper gastrointestinal tract. Some of the zinc in the food matrix may, however, be co-absorbed with amino acids over the whole length of the small intestine . Co-absorption of zinc with amino acids may explain the greater effects of zinc taken with food on omega-6 fatty acid desaturation . The investigators propose that this effect may be maximized by providing supplemental zinc complexed with amino acids. Since the zinc amino acid complex likely mimics the absorption and retention of zinc bound to protein in food, the investigators further propose that zinc, bound to amino acids taken in the fasted state will be directed into the cellular compartments more efficiently than zinc associated with gluconate.
The primary aim in this study is to determine whether providing a zinc amino acid complex has a greater effect on indices of essential fatty acid desaturation compared with zinc gluconate when the zinc complexes are taken in the fasting state.
The investigators hypothesize that taking a zinc amino acid (Zn-AA) complex in a fasted state daily for two weeks has a greater effect on the Fatty Acid Desaturase 1 (FADS1) activity compared with zinc gluconate. Also, if the uptake of ionic zinc gluconate into cellular compartments is reduced in comparison to Zn-AA because the zinc gluconate is retained in the plasma, two weeks of a daily zinc gluconate will have a greater effect on fasting plasma zinc concentrations compared to a Zn- AA complex.
详细描述
Once the informed consent is obtained and the schedule is set with the participant, the participant will pick up their zinc bottle they will consume for the first two weeks and will start the study on the scheduled date.
Visit 1 (Week 1, Day 1): The participants will come to Morgan Hall fasting for their first blood draw visit. They will come to the clinic after an 8-hour fast and we will collect a blood sample. They will be instructed to take their zinc starting on day 2 every morning thirty minutes prior to having their regular breakfast and to write what they eat for breakfast in their breakfast log daily. They will take the given zinc for thirteen days (days 2-14).
Visit 2 (Week 2, Day 15): The participants will come to Morgan Hall after an 8-hour fast and the investigators will collect a second blood sample. Subjects will then be given instructions for visits three and four which will take place two weeks later to allow for a washout period between the crossover studies.
Visit 3 (Week 5, Day 1): The participants will come to Morgan Hall fasting for their third blood draw visit. They will come to the clinic after an 8-hour fast and the investigators will collect a blood sample. Subjects will be instructed to take the alternate zinc starting on day 2 every morning thirty minutes prior to having their regular breakfast and to record their breakfast in their breakfast log daily. They will take the given zinc for thirteen days (days 2-14).
Visit 4: (Week 6, Day 15): The participants will come to Morgan Hall after an 8-hour fast and the investigators will collect a final fourth blood sample. The subjects' breakfast logs will be collected at this time and their participation in the study will be completed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The two zinc supplements will have the same appearance, and will be in coded bottles, such that the participant, care provider, investigator, and outcomes assessor may be kept unaware of the order of the supplements for each participant until the data analysis is complete.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men (i.e., have no current health issues requiring medications or a specific diet)
- •18 to 50 years of age
- •Body mass index between 18 and 30 kg/m2
- •Willing to take zinc supplements provided by the study for a total of four weeks
排除标准
- •History of heart disease, any inflammatory disorder including inflammatory bowel syndrome or arthritis, or any cancer treatment, or previously diagnosed with HIV
- •Smoking or alcohol abuse, use of illicit drugs
- •Any contraindication to venipuncture such as bleeding disorders or use of blood thinners
- •Those taking vitamins or supplements including minerals and omega oils, who cannot agree to stop taking the supplements two weeks prior to the study and for the duration of the study
结局指标
主要结局
FADS1 activity index
时间窗: Day 1 (baseline 1), day 15 (endpoint 1), day 29 (baseline 2), day 43 (endpoint 2)
The molar ratio (unitless) of arachidonic acid to dihomo-gamma-linolenic acid, i.e., fatty acid desaturase 1 (FADS1) product to precursor.
次要结局
- Fasted plasma zinc concentration(Day 1 (baseline 1), day 15 (endpoint 1), day 29 (baseline 2), day 43 (endpoint 2))