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临床试验/NL-OMON33090
NL-OMON33090已完成不适用

The effect of two dosages of theobromine and caffeine on mood and cognition in healthy subjects - 08063V theobromine and caffeine

nilever0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Age at start of the study >= 18 and <= 55 years
  • Being female
  • Body mass index (BMI) >= 18.5 and <= 30.0 kg/m2.
  • Reported alcohol consumption < 14 alcohol units/week
  • Agreeing to be informed about medically relevant personal test-results
  • Informed consent signed
  • Willing to refrain from caffeine and theobromine for 28 hours, from 8 p.m. on the day prior to the measurement day until the end of the measurement day (0:00 - midnight)
  • Apparently healthy: no reported current or previous diseases or disorders which might effect study measurements assessed by Research physician
  • Consuming animal foods products (gelatine).
  • Consumes dark chocolate at least once in a month
  • Having a general practitioner (GP)

排除标准

  • Being an Unilever employee
  • Consumes more than 250 mg caffeine daily
  • Using or planning to use any medically prescribed diet or weight-loss diet or making any attempt to control diet at screening and during the entire study.
  • Reported intense sporting activities > 10 h/w
  • Subjects who undergoing medical treatment that may interfere with the study outcome.
  • Use of systemic antibiotics in the period of 3 months prior to the study
  • Reported participation in another biomedical study 1 month before the start or during the study.
  • Reported intolerance or allergy for one of test products or standardized meal
  • The habit of smoking during the past half year or using nicotine containing medicines during the past month
  • Reported lactating (or lactating < 6 weeks ago), pregnant (or pregnant < 3 months ago) or wish to become pregnant during the study
  • Office systolic blood pressure > 160 mmHg and/ or diastolic blood pressure > 95 mmHg, irregular heart rate and/or heart rate > 100 bpm. Eligibility of subjects with a heart rate <56 bpm will be assessed by the research physician
  • Not able to perform the computer tasks assessed during screening
  • Reported participation in night shift work during the study period

研究者

发起方
nilever

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