4 Weeks Supplementation of Huel Ready to Eat FoodsNCT07049874
The Effect of Huel on Markers of Inflammation
A study testing Huel in people with 4 Weeks Supplementation of Huel Ready to Eat Foods, run by Newcastle University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 4 Weeks Supplementation of Huel Ready to Eat Foods
- What is being tested?
- Huel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy Aged 18 years and over Non-pregnant, Non-lactating non-smoking
Who cannot join
- Smoker Pregnant Lactating BMI >30 Food allergy Disordered eating Disorder which could impact the study outcomes Medications which could impact the study outcomes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Faculty of Medical Sciences
Newcastle upon Tyne, Tyne and Wear, NE18ST
About this study
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).
- Being tested
- Huel
- Keywords
- protein, plant based, Plant protein, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuelDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| 4 weeks consumption of Huel ready to eat foods | Experimental | Not described Receives: Dietary Supplement: Huel |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-Reactive protein
Measured: baseline and after 4 weeks supplementation
neutrophils
Measured: baseline and after 4 weeks supplementation
TNF-alpha
Measured: baseline and after 4 weeks supplementation
IL-10
Measured: baseline and after 4 weeks supplementation
IL-6
Measured: baseline and after 4 weeks supplementation
Secondary outcomes (7)
linoleic acid
Measured: baseline and after 4 weeks supplementation
arachidonic acid
Measured: baseline and after 4 weeks supplementation
alpha-linoleic acid
Measured: baseline and after 4 weeks supplementation
eicosapentaenoic acid
Measured: baseline and after 4 weeks supplementation
Body Mass Index
Measured: baseline and after 4 weeks supplementation
Body mass
Measured: baseline and after 4 weeks supplementation
Waist cercumference
Measured: baseline and after 4 weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Feb 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 4 Weeks Supplementation of Huel Ready to Eat FoodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Aelius Biotech
- Responsible party
- Principal investigator, Anthony Watson, Newcastle University
- Investigators
- Anthony W Watson, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049874
- Sponsor's protocol ID
- Prot1
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not acceptable due to the ethical approval given
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Huel on Markers of Inflammation
- ClinicalTrials.gov ID
- NCT07049874
- Acronym / sponsor ID
- Prot1
- Keywords
- protein, plant based, Plant protein, inflammation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Aelius Biotech
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4 weeks consumption of Huel ready to eat foods | Experimental | Dietary Supplement: Huel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generally healthy Aged 18 years and over Non-pregnant, Non-lactating non-smoking
Key exclusion criteria (1 listed)
- Smoker Pregnant Lactating BMI >30 Food allergy Disordered eating Disorder which could impact the study outcomes Medications which could impact the study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuelReady 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 | Dietary supplement | 4 weeks consumption of Huel ready to eat foods |
Primary outcome
C-Reactive protein
Time frame: baseline and after 4 weeks supplementation
neutrophils
Time frame: baseline and after 4 weeks supplementation
TNF-alpha
Time frame: baseline and after 4 weeks supplementation
IL-10
Time frame: baseline and after 4 weeks supplementation
IL-6
Time frame: baseline and after 4 weeks supplementation
7 secondary outcomes
linoleic acid
Time frame: baseline and after 4 weeks supplementation
arachidonic acid
Time frame: baseline and after 4 weeks supplementation
alpha-linoleic acid
Time frame: baseline and after 4 weeks supplementation
eicosapentaenoic acid
Time frame: baseline and after 4 weeks supplementation
Body Mass Index
Time frame: baseline and after 4 weeks supplementation
Body mass
Time frame: baseline and after 4 weeks supplementation
Waist cercumference
Time frame: baseline and after 4 weeks supplementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No. This is not acceptable due to the ethical approval given
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony W Watson, PhD principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Huel in people with 4 Weeks Supplementation of Huel Ready to Eat Foods, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-Reactive protein (time frame: baseline and after 4 weeks supplementation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.