NCT07049874

Brief 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. 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 25, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

proteinplant basedPlant proteininflammation

Outcome Measures

Primary Outcomes (5)

  • C-Reactive protein

    baseline and after 4 weeks supplementation

  • neutrophils

    baseline and after 4 weeks supplementation

  • TNF-alpha

    baseline and after 4 weeks supplementation

  • IL-10

    baseline and after 4 weeks supplementation

  • IL-6

    baseline and after 4 weeks supplementation

Secondary Outcomes (7)

  • linoleic acid

    baseline and after 4 weeks supplementation

  • arachidonic acid

    baseline and after 4 weeks supplementation

  • alpha-linoleic acid

    baseline and after 4 weeks supplementation

  • eicosapentaenoic acid

    baseline and after 4 weeks supplementation

  • Body Mass Index

    baseline and after 4 weeks supplementation

  • +2 more secondary outcomes

Study Arms (1)

4 weeks consumption of Huel ready to eat foods

EXPERIMENTAL
Dietary Supplement: Huel

Interventions

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

4 weeks consumption of Huel ready to eat foods

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy Aged 18 years and over Non-pregnant, Non-lactating non-smoking

You may not qualify if:

  • Smoker Pregnant Lactating BMI \>30 Food allergy Disordered eating Disorder which could impact the study outcomes Medications which could impact the study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medical Sciences

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

Location

MeSH Terms

Conditions

Inflammation

Interventions

SLC30A9 protein, human

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony W Watson, PhD

    Newcastle University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This is an open label study
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Human Nutrition

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 3, 2025

Study Start

February 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

This is not acceptable due to the ethical approval given

Locations