Clinical trial NCT06061419: The Effect of Huel Powder on Appetite
Official title: The Effect of Huel Powder on Appetite
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hunger
Keywords: Satiety
Appetite
Lead sponsor: Newcastle University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, open label crossover study
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hunger Visual Analogue Score
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: Satisfied Visual Analogue Score
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: Fullness Visual Analogue Score
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: How much can you eat Visual Analogue Score
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary outcomes:
measure: Sweet Visual Analogue Score
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: Salty Visual Analogue Score
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: Savoury Visual Analogue Score
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: Fatty Visual Analogue Score
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: PYY
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: Ghrelin
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: CCK
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: Glucose
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
measure: Insulin
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 minutes
Other outcomes:
Locations:
Study officials:
References: