Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03568864
Other study ID # 170712/A/01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 31, 2017
Est. completion date March 14, 2018

Study information

Verified date June 2018
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The production of protein rich animal products is associated with a large environmental burden, and with ethical considerations. Additionally, the over-consumption of meat might be associated with detrimental effects to health.

Using mycoprotein, a food ingredient derived from the fermentation of a fungus, as a meat substitute could result in environmental benefits, and could have a role in managing obesity, diabetes and improving metabolic health. However, naturally produced mycoprotein has a high nucleotide content and little is known about the impact of nucleotides in uric acid levels and other health markers.

The aim of this study is to investigate the effect of a meal based on nucleotide rich mycoprotein on uric acid concentrations and other markers of health.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 14, 2018
Est. primary completion date March 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- BMI between 18 and 30

Exclusion Criteria:

- On medication (except contraception)

- Smokers

- Diagnosed with any metabolic or cardiovascular conditions

- BMI < 18 or > 30

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Low nucleotide meal
The participants will consume a mixed meal (sandwich) containing a nucleotide depleted mycoprotein product (low in nucleotides)
High nucleotide meal
The participants will consume a mixed meal (sandwich) containing a non nucleotide depleted mycoprotein product (high in nucleotides)

Locations

Country Name City State
United Kingdom St Luke's Campus - University of Exeter Exeter Devon

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in serum uric acid concentrations over a 24 h period Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 8, 12 and 24 hours after meal
Secondary Blood glucose Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 24 hours after meal
Secondary Serum insulin Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
Secondary Branched chained amino-acids Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1