The Effect of Huel Powder on Appetite

Hunger Clinical Trial

Official title:

The Effect of Huel Powder on Appetite

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06061419
• Other study ID #: 2480/28560
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: June 2023
• Source: Newcastle University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hunger

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hunger Visual Analogue Score	How hungry do you feel?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Primary	Satisfied Visual Analogue Score	How satisfied do you feel?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Primary	Fullness Visual Analogue Score	How full do you feel?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Primary	How much can you eat Visual Analogue Score	How much do you think you can eat?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary	Sweet Visual Analogue Score	Would you like to eat something sweet?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary	Salty Visual Analogue Score	Would you like to eat something salty?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary	Savoury Visual Analogue Score	Would you like to eat something savoury?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary	Fatty Visual Analogue Score	Would you like to eat something fatty?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary	PYY	Concentration of Peptide YY in plasma (pg/ml)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary	Ghrelin	Concentration of Ghrelin in plasma (pg/ml)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary	CCK	Concentration of Cholecystokinin in plasma (pg/ml)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary	Glucose	Concentration of glucose in plasma (mmol/l)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary	Insulin	Concentration of Insulin in plasma (pmol/l)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes