Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans (EGGS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Changes in Platelet Function With Increased Choline Intake
研究概览
简要总结
The investigators are interested in learning more about choline, a nutrient required by the body. The body does make some choline, but it does not make enough to support health and the rest must be acquired through diet. Eggs, and especially egg yolks, are a major dietary source of choline. Choline can also be given as a dietary supplement. Ingestion of choline supplements has been linked to an increased concentration of a compound called TMAO (trimethylamine N-oxide). Elevated TMAO levels have been linked to higher heart disease risk. With this study, the investigators hope to learn whether there is a difference in the way your body responds to the ingestion of a choline supplement versus the choline found within eggs.
详细描述
The principal goal for the study is to examine whether there is a difference between the ingestion of choline through supplements versus choline found within eggs on plasma TMAO levels. The investigators have previously shown that dietary intake of trimethylamines, including the choline group of phosphatidylcholine (PC), is mechanistically linked to cardiovascular disease risk and that the metabolism of these trimethylamine nutrients in humans is modulated by the intestinal microbes (gut microbes). Additionally, extensive animal studies link an essential role of gut microbiota to the metabolism of choline and the production of metabolites that promote / accelerate atherosclerotic processes. The investigators have also recently shown a 10-fold increase in plasma TMAO levels following supplementation with choline bitartrate supplements. However, another pilot study by a collaborator (unpublished) did not show the same increase in plasma TMAO levels following the ingestion of whole eggs, a major dietary source of choline. Therefore, with this study the investigators wish to examine the differences, if any, between the ingestion of an equivalent mass of total choline in the free form (as bitartrate salt) as a supplement vs. within whole eggs.
Eggs, and specifically the egg yolk, contain a large amount of total choline. However, egg white contains potential anti-microbial peptides that could influence gut microbial composition and function, and therefore impact conversion of choline into TMA and TMAO observed in subjects. Therefore, the investigators hypothesize that the consumption of whole eggs (hardboiled) will not elevate plasma TMAO levels to the same extent as a comparable amount of total choline ingested in capsule form as the choline bitartrate salt. The investigators further hypothesize that the consumption of egg white with choline bitartrate tablets may result in less of a rise in TMAO levels than ingestion of the choline bitartrate supplement alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Men and women age 18 years or above.
- •Willing to remain on aspirin or stay off aspirin or aspirin products for 1 week prior to starting the study and throughout the study period.
- •Able to provide informed consent and comply with study protocol.
- •Able to be off all other supplements during the study period.
排除标准
- •Significant chronic illness.
- •Active infection or received antibiotics within 1 month of study enrollment.
- •Use of over-the-counter probiotic within the past month
- •Chronic gastrointestinal disorders, such as ulcerative colitis or Crohn's disease.
- •Allergy to eggs or lactose.
- •Having undergone bariatric procedures or surgeries such as gastric banding or bypass.
- •Pregnancy.
- •Any condition that, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial or cause inability to comply with the trial.
研究组 & 干预措施
Whole Hardboiled Eggs
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
干预措施: Pre-cooked, pre-peeled whole hardboiled eggs (Other)
Choline Bitartrate Tablets
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
干预措施: Choline Bitartrate (Dietary Supplement)
Hardboiled Eggs + Choline Bitartrate Tablets
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
干预措施: Pre-cooked, pre-peeled whole hardboiled eggs (Other)
Egg Whites + Choline Bitartrate Tablets
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
干预措施: Egg whites from pre-cooked, pre-peeled hardboiled eggs (Other)
Hardboiled Eggs + Choline Bitartrate Tablets
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
干预措施: Choline Bitartrate (Dietary Supplement)
Egg Whites + Choline Bitartrate Tablets
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
干预措施: Choline Bitartrate (Dietary Supplement)
Phosphatidylcholine Capsules
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
干预措施: Phosphatidylcholine capsules (Dietary Supplement)
结局指标
主要结局
Changes in Platelet Function With Increased Choline Intake
时间窗: Baseline, Day 28
The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.
Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite
时间窗: Baseline, 28 days
Changes in levels of non-labeled TMAO from baseline to end-of-study (day 28) as measured by established techniques by mass spectrometry.
次要结局
- Changes in Lipid Profile, Total Cholesterol(Baseline, Day 28)
- Changes in Plasma Levels of Fasting Betaine.(Baseline, Day 28)
- Changes in Lipid Profile, Triglycerides(Baseline, Day 28)
- Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections(Baseline, Day 28)
- Changes in Plasma Levels of Fasting Choline(Baseline, Day 28)
- Changes in Plasma Levels of Fasting Carnitine.(Baseline, Day 28)
- Changes in Lipid Profile, HDL(Baseline, Day 28)
- Changes in Lipid Profile, LDL(Baseline, Day 28)
研究者
Wilson Tang
Staff, Cardiovascular Medicine, The Cleveland Clinic; Staff, Cellular and Molecular Medicine, The Cleveland Clinic Lerner Research Institute
The Cleveland Clinic