- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07049874
- Original Trial
The Effect of Huel on Markers of Inflammation
June 25, 2025 updated by: Anthony Watson, Newcastle University
This project will assess the effect of Huel on markers of gastrointestinal inflammation of 30 generally healthy individuals.
The aim is to identify any changes in the markers of inflammation status of volunteers in any of the 9 markers to be monitored.
Inflammation status will be measured at the start of the study, after one week of their habitual diets and again after four weeks of consuming two ready to drink Huel products per day, one Hot & Savoury Huel (grain-based option only) and the remainder of their calorie intake to be made up of Huel Powder (v3.1).
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne and wear
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Newcastle Upon Tyne, Tyne and wear, United Kingdom, NE18ST
- Faculty of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Generally healthy Aged 18 years and over Non-pregnant, Non-lactating non-smoking
Exclusion Criteria:
Smoker Pregnant Lactating BMI >30 Food allergy Disordered eating Disorder which could impact the study outcomes Medications which could impact the study outcomes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 4 weeks consumption of Huel ready to eat foods
|
Ready to eat huel foods.
Containing 2 ready to drink shakes, one savoury meal pack and meal replacement powder.
Consumption amounts were based on energy needs of each person
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
C-Reactive protein
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
neutrophils
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
TNF-alpha
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
IL-10
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
IL-6
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
linoleic acid
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
arachidonic acid
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
alpha-linoleic acid
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
eicosapentaenoic acid
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
Body Mass Index
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
Body mass
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
|
Waist cercumference
Time Frame: baseline and after 4 weeks supplementation
|
baseline and after 4 weeks supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anthony W Watson, PhD, Newcastle University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2025
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
June 25, 2025
First Submitted That Met QC Criteria
June 25, 2025
First Posted (Actual)
July 3, 2025
Study Record Updates
Last Update Posted (Actual)
July 3, 2025
Last Update Submitted That Met QC Criteria
June 25, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prot1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is not acceptable due to the ethical approval given
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Huel
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Newcastle UniversityCompleted