跳至主要内容
临床试验/NCT02987868
NCT02987868已完成不适用

Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine

Pennington Biomedical Research Center0 个研究点目标入组 16 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
16
主要终点
Percent Change of Triiodthyronine Over Baseline

研究概览

简要总结

In a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hGH) increased 682% above baseline 120 minutes after oral administration of an amino acid-based dietary supplement (SeroVital), p=0.01 vs placebo. In contrast to the mechanism of hGH stimulation by ghrelin, the investigators hypothesize that the supplement suppresses somatostatin, a know inhibitor of both hGH and TSH. To test this hypothesis, the investigators measured triiodothyronine (T3) after administration of the amino acid-base supplement.

详细描述

Two molecular targets that regulate the synthesis and secretion of human growth hormone (hGH) include 1) ghrelin, an endogenous ligand secreted by the stomach that also has appetite-stimulation properties distinct from its hGH-stimulating effects, and 2) somatostatin, a family of 14 and 28 amino acid peptides that act as a potent noncompetitive inhibitor of the release of hGH. the investigators recently reported that oral administration of a 2.9g/dose of SeroVital, a blend of l-lysine HCl, l-arginine HCL, oxo-proline, N-acetyl-l-cysteine, l-glutamine, and schizonepeta (aerial parts) powder, leads to a significant 682% mean increase in endogenous hGH levels in male and female subjects in a period of 120 minutes following acute consumption. In the work presented here, the investigators seek to characterize the mechanistic target associated with this measured increase in endogenous hGH by SeroVital, which the investigators hypothesize to be somatostatin. The investigators test this hypothesis by assaying thyroid function, a secondary inhibition target of somatostatin. The investigators further compare our findings to ghrelin-based hGH secretagogues.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 12 healthy males and 4 healthy females
  • Between 18 and 70 years

排除标准

  • Pregnant or nursing
  • Taking any chronic medication including birth control pills.

研究组 & 干预措施

Supplement 1st day, placebo 2nd day

Active Comparator

Administration of oral supplement (proprietary amino acid derivative blend). Half of the participants took the Amino acid supplement first day and half of the participants took the Amino acid supplement second day.

干预措施: Amino acid supplement first day (Drug)

Supplement 1st day, placebo 2nd day

Active Comparator

Administration of oral supplement (proprietary amino acid derivative blend). Half of the participants took the Amino acid supplement first day and half of the participants took the Amino acid supplement second day.

干预措施: Placebo second day (Drug)

Placebo 1st day, supplement 2nd day

Placebo Comparator

Half of the participants took the placebo first day and half of the participants took placebo second day.

干预措施: Placebo first day (Drug)

Placebo 1st day, supplement 2nd day

Placebo Comparator

Half of the participants took the placebo first day and half of the participants took placebo second day.

干预措施: Amino acid supplement second day (Drug)

结局指标

主要结局

Percent Change of Triiodthyronine Over Baseline

时间窗: 0-120 minutes, at Baseline and post dose, week 1 and week 3

Measure Triiodthyronine at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank Greenway

Principal Investigator

Pennington Biomedical Research Center

相似试验