HungerNCT06061419
The Effect of Huel Powder on Appetite
A study testing Huel Powder in people with Hunger, run by Newcastle University.
Trial summary
This project will assess the effect of Huel powdered food on the satiety of 40 generally healthy volunteers compared to a standard breakfast of cornflakes and milk. To achieve this, we will recruit 40 (non-smoking) generally healthy volunteers to attend the study centre on two separate occasions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hunger
- What is being tested?
- Huel Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Non-pregnant/lactating
- No known food allergies
- BMI between 20-30
Who cannot join
- Diagnosed eating disorder
- receiving regular medication (except contraceptives or statins)
- long-term illness such as high blood pressure, heart disease
- taking medication that can affect kidney function
About this study
This project will assess the effect of Huel powdered food on the satiety of 40 generally healthy volunteers compared to a standard breakfast of cornflakes and milk.
To achieve this, we will recruit 40 (non-smoking) generally healthy volunteers to attend the study centre on two separate occasions. On each occasion they will arrive at the study centre fasted and will be given their breakfast of either Huel or Cornflakes and milk, matched for calorie content.
The aim is to identify the size and duration of any effect on satiety of the two meals.
Read the detailed description
This project will assess the effect of Huel Food replacement on the satiety of 40 generally healthy volunteers compared to a standard breakfast of cornflakes and milk.
To achieve this, we will recruit 40 (non-smoking) generally healthy volunteers to attend the study centre on two separate occasions. On each occasion they will arrive at the study centre fasted and will be given their breakfast of either Huel or Cornflakes and milk, matched for calorie content.
We will ask volunteers to come to the research facility in Newcastle University, before they have had any breakfast, on two separate occasions. The volunteers must not eat or drink anything (except water) after 8 pm the evening before they come in. This includes not drinking any alcohol, tea, or coffee.
BMI, weight, and body composition (measured via electrical impedance) will also be taken at the initial visit to ensure they meet the inclusion criteria
All volunteers will be asked to complete screening questionnaires focusing on morning eating and exercise routine and the 'three factor eating' questionnaire before or during their screening visit.
A subset of volunteers (eight in total) will be recruited to collected blood samples throughout the two study visits. These volunteers will go through the same screening process but will also have their veins assessed for cannulation suitability.
During the two study visits, both sets of volunteers will be asked to complete appetite questionnaires every 15 minutes for the first hour and every 30 minutes for the remaining 3 hours.
Volunteers who have consented to provide blood samples will be asked to give samples just before they complete the appetite questionnaires.
The blood samples will be assessed for Ghrelin, CCK, PYY, Glucose, and Insulin.
All researchers are trained in GCP, phlebotomy and cannulation.
- Conditions
- Hunger
- Being tested
- Huel Powder
- Keywords
- Satiety, Appetite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huel PowderOther
Huel Powder v3.0 white, vanilla flavour
| Study group | Role | What they receive |
|---|---|---|
| Huel Powder | Active comparator | This arm of the study will receive Huel as their first study meal with cornflakes and milk as their second Receives: Other: Huel Powder |
| Cornflakes and Milk | Active comparator | This arm of the study will receive cornflakes and milk as their first study meal with Huel as their second Receives: Other: Huel Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunger Visual Analogue Score
How hungry do you feel?
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Satisfied Visual Analogue Score
How satisfied do you feel?
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Fullness Visual Analogue Score
How full do you feel?
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
How much can you eat Visual Analogue Score
How much do you think you can eat?
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary outcomes (9)
Sweet Visual Analogue Score
Would you like to eat something sweet?
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Salty Visual Analogue Score
Would you like to eat something salty?
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Savoury Visual Analogue Score
Would you like to eat something savoury?
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Fatty Visual Analogue Score
Would you like to eat something fatty?
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
PYY
Concentration of Peptide YY in plasma (pg/ml)
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Ghrelin
Concentration of Ghrelin in plasma (pg/ml)
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
CCK
Concentration of Cholecystokinin in plasma (pg/ml)
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Glucose
Concentration of glucose in plasma (mmol/l)
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Insulin
Concentration of Insulin in plasma (pmol/l)
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start29 Sep 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HungerStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, open label crossover study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061419
- Sponsor's protocol ID
- 2480/28560
- Status last verified
- Jun 2023
- First submitted
- 24 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Huel Powder on Appetite
- ClinicalTrials.gov ID
- NCT06061419
- Acronym / sponsor ID
- 2480/28560
- Conditions
- Hunger
- Keywords
- Satiety, Appetite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- 29 Sep 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 29 Sep 2023 (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 powdered food on the satiety of 40 generally healthy volunteers compared to a standard breakfast of cornflakes and milk.
To achieve this, we will recruit 40 (non-smoking) generally healthy volunteers to attend the study centre on two separate occasions. On each occasion they will arrive at the study centre fasted and will be given their breakfast of either Huel or Cornflakes and milk, matched for calorie content.
The aim is to identify the size and duration of any effect on satiety of the two meals.
Detailed description
This project will assess the effect of Huel Food replacement on the satiety of 40 generally healthy volunteers compared to a standard breakfast of cornflakes and milk.
To achieve this, we will recruit 40 (non-smoking) generally healthy volunteers to attend the study centre on two separate occasions. On each occasion they will arrive at the study centre fasted and will be given their breakfast of either Huel or Cornflakes and milk, matched for calorie content.
We will ask volunteers to come to the research facility in Newcastle University, before they have had any breakfast, on two separate occasions. The volunteers must not eat or drink anything (except water) after 8 pm the evening before they come in. This includes not drinking any alcohol, tea, or coffee.
BMI, weight, and body composition (measured via electrical impedance) will also be taken at the initial visit to ensure they meet the inclusion criteria
All volunteers will be asked to complete screening questionnaires focusing on morning eating and exercise routine and the 'three factor eating' questionnaire before or during their screening visit.
A subset of volunteers (eight in total) will be recruited to collected blood samples throughout the two study visits. These volunteers will go through the same screening process but will also have their veins assessed for cannulation suitability.
During the two study visits, both sets of volunteers will be asked to complete appetite questionnaires every 15 minutes for the first hour and every 30 minutes for the remaining 3 hours.
Volunteers who have consented to provide blood samples will be asked to give samples just before they complete the appetite questionnaires.
The blood samples will be assessed for Ghrelin, CCK, PYY, Glucose, and Insulin.
All researchers are trained in GCP, phlebotomy and cannulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, open label crossover study
| Arm | Type | Receives |
|---|---|---|
| Huel Powder | Active comparator | Other: Huel PowderThis arm of the study will receive Huel as their first study meal with cornflakes and milk as their second |
| Cornflakes and Milk | Active comparator | Other: Huel PowderThis arm of the study will receive cornflakes and milk as their first study meal with Huel as their second |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Generally Healthy
- Non-pregnant/lactating
- No known food allergies
- BMI between 20-30
Key exclusion criteria (4 listed)
- Diagnosed eating disorder
- receiving regular medication (except contraceptives or statins)
- long-term illness such as high blood pressure, heart disease
- taking medication that can affect kidney function
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 |
|---|---|---|
| Huel PowderHuel Powder v3.0 white, vanilla flavour | Other | Cornflakes and Milk, Huel Powder |
Primary outcome
Hunger Visual Analogue Score
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
How hungry do you feel?
Satisfied Visual Analogue Score
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
How satisfied do you feel?
Fullness Visual Analogue Score
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
How full do you feel?
How much can you eat Visual Analogue Score
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
How much do you think you can eat?
9 secondary outcomes
Sweet Visual Analogue Score
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Salty Visual Analogue Score
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Savoury Visual Analogue Score
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Fatty Visual Analogue Score
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
PYY
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Ghrelin
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
CCK
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Glucose
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Insulin
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Huel Powder in people with Hunger, run by Newcastle University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Hunger Visual Analogue Score (time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes). The study lists 4 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 29 Sep 2023.