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Clinical Trials/DRKS00023304
DRKS00023304
Completed
未知

A proof of concept study to evaluate the impact of a food supplement on uptake and anti-inflammatory properties of omega-3 fatty acid derived specialized pro-resolution lipid mediators - BTS1487/20

Evonik Operations GmbH0 sites19 target enrollmentNovember 2, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Healthy volunteers
Sponsor
Evonik Operations GmbH
Enrollment
19
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 2, 2020
End Date
December 23, 2020
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • BMI 25\-35,
  • Omega\-3 Index \< 6%,
  • Non\-smoker

Exclusion Criteria

  • (1\) Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro\-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
  • (2\) Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as omega\-3 fatty acids, probiotics, anti\-spasmodic, laxatives and anti\-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2\-antagonists, fibers etc.) within 2 weeks prior to study start or during the study
  • (3\) Intake of antibiotics in the last 2 months and laxatives in the last 2 weeks
  • (4\) Significant changes in lifestyle or medication (within last 2 months) or surgical intervention or surgical procedure such as bariatric surgery
  • (5\) Subjects consuming
  • food or drinks claimed as ‘probiotic’ more than once weekly
  • more than 3 portions of fruits and vegetables (sum) per day
  • (6\) Subjects with stool frequency of \= 2 stools per week
  • (7\) Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co\-operate during the study.
  • (8\) Relevant allergy or known hypersensitivity against compounds of the study preparations

Outcomes

Primary Outcomes

Not specified

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