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Active, Not Recruiting

NCT Number: NCT07049874

The Effect of Huel on Markers of Inflammation

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

4 Weeks Supplementation of Huel Ready to Eat Foods Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medical Sciences

Newcastle upon Tyne, Tyne and Wear, NE18ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Huel

Dietary 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

Primary outcomes

  1. C-Reactive protein

    Time frame: baseline and after 4 weeks supplementation

  2. neutrophils

    Time frame: baseline and after 4 weeks supplementation

  3. TNF-alpha

    Time frame: baseline and after 4 weeks supplementation

  4. IL-10

    Time frame: baseline and after 4 weeks supplementation

  5. IL-6

    Time frame: baseline and after 4 weeks supplementation

Secondary outcomes

  1. linoleic acid

    Time frame: baseline and after 4 weeks supplementation

  2. arachidonic acid

    Time frame: baseline and after 4 weeks supplementation

  3. alpha-linoleic acid

    Time frame: baseline and after 4 weeks supplementation

  4. eicosapentaenoic acid

    Time frame: baseline and after 4 weeks supplementation

  5. Body Mass Index

    Time frame: baseline and after 4 weeks supplementation

  6. Body mass

    Time frame: baseline and after 4 weeks supplementation

  7. Waist cercumference

    Time frame: baseline and after 4 weeks supplementation

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Collaborators

  • Aelius Biotech

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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