The Effect of Huel Powder on Appetite

Sponsor
Newcastle University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06061419
Collaborator
(none)
40
2
4

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Huel Powder
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomised, open label crossover studyRandomised, open label crossover study
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of Huel Powder on Appetite
Anticipated Study Start Date :
Sep 29, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Huel Powder

This arm of the study will receive Huel as their first study meal with cornflakes and milk as their second

Other: Huel Powder
Huel Powder v3.0 white, vanilla flavour

Active Comparator: Cornflakes and Milk

This arm of the study will receive cornflakes and milk as their first study meal with Huel as their second

Other: Huel Powder
Huel Powder v3.0 white, vanilla flavour

Outcome Measures

Primary Outcome Measures

  1. Hunger Visual Analogue Score [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    How hungry do you feel?

  2. Satisfied Visual Analogue Score [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    How satisfied do you feel?

  3. Fullness Visual Analogue Score [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    How full do you feel?

  4. How much can you eat Visual Analogue Score [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    How much do you think you can eat?

Secondary Outcome Measures

  1. Sweet Visual Analogue Score [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    Would you like to eat something sweet?

  2. Salty Visual Analogue Score [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    Would you like to eat something salty?

  3. Savoury Visual Analogue Score [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    Would you like to eat something savoury?

  4. Fatty Visual Analogue Score [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    Would you like to eat something fatty?

  5. PYY [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    Concentration of Peptide YY in plasma (pg/ml)

  6. Ghrelin [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    Concentration of Ghrelin in plasma (pg/ml)

  7. CCK [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    Concentration of Cholecystokinin in plasma (pg/ml)

  8. Glucose [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    Concentration of glucose in plasma (mmol/l)

  9. Insulin [0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes]

    Concentration of Insulin in plasma (pmol/l)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Generally Healthy

  • Non-pregnant/lactating

  • No known food allergies

  • BMI between 20-30

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Newcastle University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Newcastle University
ClinicalTrials.gov Identifier:
NCT06061419
Other Study ID Numbers:
  • 2480/28560
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Newcastle University

Study Results

No Results Posted as of Sep 29, 2023