The Effect of Huel Powder on Appetite

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hunger
• Intervention / Treatment: Other: Huel Powder

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hunger Visual Analogue Score	How hungry do you feel?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Satisfied Visual Analogue Score	How satisfied do you feel?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Fullness Visual Analogue Score	How full do you feel?	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?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sweet Visual Analogue Score	Would you like to eat something sweet?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Salty Visual Analogue Score	Would you like to eat something salty?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Savoury Visual Analogue Score	Would you like to eat something savoury?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Fatty Visual Analogue Score	Would you like to eat something fatty?	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
PYY	Concentration of Peptide YY in plasma (pg/ml)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Ghrelin	Concentration of Ghrelin in plasma (pg/ml)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
CCK	Concentration of Cholecystokinin in plasma (pg/ml)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Glucose	Concentration of glucose in plasma (mmol/l)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Insulin	Concentration of Insulin in plasma (pmol/l)	0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes

Collaborators and Investigators

• Sponsor: Newcastle University

Study record dates

Study Major Dates

• Study Start (Estimated): September 29, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: September 24, 2023
• First Submitted That Met QC Criteria: September 24, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Satiety; Appetite
• Other Study ID Numbers: 2480/28560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No