NCT06061419

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

September 29, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

September 24, 2023

Last Update Submit

September 24, 2023

Conditions

Keywords

SatietyAppetite

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (9)

  • Sweet Visual Analogue Score

    0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes

  • Salty Visual Analogue Score

    0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes

  • Savoury Visual Analogue Score

    0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes

  • Fatty Visual Analogue Score

    0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes

  • PYY

    0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes

  • +4 more secondary outcomes

Study Arms (2)

Huel Powder

ACTIVE COMPARATOR

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

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

Other: Huel Powder

Interventions

Huel Powder v3.0 white, vanilla flavour

Cornflakes and MilkHuel Powder

Eligibility Criteria

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

You may qualify if:

  • Generally Healthy
  • Non-pregnant/lactating
  • No known food allergies
  • BMI between 20-30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomised, open label crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2023

First Posted

September 29, 2023

Study Start

September 29, 2023

Primary Completion

December 30, 2023

Study Completion

January 30, 2024

Last Updated

September 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share