Clinical trial NCT04240795: Effect of Lubricity of Food Gels on Satiation and Satiety
Official title: The Effects of Hydrogels Differing in Their Lubricity on Appetite Control, Satiety, Subsequent Food Intake and Salivary Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Keywords: Food Structure
Gel
Satiety
Appetite
Food intake
Salivary biomarkers
Mucin
Amylase
Hunger
Fullness
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Tightly controlled cross-over study design with three arms.
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the study is to elucidate the influence of fibre-based hydrogels differing in their mechanical properties (characterized both instrumentally and sensorially) in terms of low/ high lubricity on satiety, satiation and salivary biomarkers.

Detailed description: An acute, randomized cross-over study that compares two types of fibre-based hydrogels differing in their lubrication properties, resulting in different pastiness and instrumental mechanical properties (lubricity). The gels are prepared using dietary fibres (kappa carrageenan, alginate). Both hydrogels contain added watermelon flavor, food grade color and sweetener. Water acts as a control and has the same flavor, color and sweetness to match the hydrogels.

Participants are asked come to the laboratory on three occasions. Before participating, each participant is screened for eligibility criteria using an online health screening questionnaire and Three Factors Eating Questionnaire. Participants are offered one of the three products (water or either of the two gels), the order of which is randomized and counterbalanced.

Participants are instructed to fast for 11 hours and to restrict from drinking alcohol for 24 hours before each session. In the first session, weight and height are measured. Participants then provide baseline (- 5 minutes) appetite ratings on a 100 mm visual analogue scale (VAS). After that they are given a standardized breakfast (females - 250kcal, males - 350 kcal). Then, participants are asked to rate their appetite on a 100-mm VAS in every 30 minutes for the next 2.5 hours. After that, they are given the preload - either hydrogels differing in their structure complexity or water. After consuming the preload, appetite ratings are recorded by the participants on three time points on 100-mm VAS. Ad libitum food is offered as lunch after 30 minutes after ingesting the preload and the last VAS is taken. Food intake is measured. Saliva is taken three times during each session after breakfast, before and after preload consumption to measure protein, mucin content, amylase activity, and salivary lubricity (tribology).

Eligibility criteria: Inclusion Criteria:

* With a normal weight (BMI=18.5 - 24.99 kg/m²)
* Generally healthy

Exclusion Criteria:

* A smoker
* Having oral infections/diseases/problems in chewing and swallowing
* Anyone with a chronic or acute health condition that may affect the ability to sense, eat, digest or absorb food
* Anyone currently using prescribed or non-prescribed medication that may interfere with the ability to sense, eat, digest or absorb food
* Anyone who is pregnant or lactating
* Anyone with a food allergy or intolerance
* Anyone who are on a special diet or are taking protein/fiber supplements
* Anyone who cannot tolerate food gels
* Underweight (BMI \<18.5 kg/m²) or overweight (25 - 29.99 kg/m²) or obese (BMI=\>29.99 kg/m²)
* Suffer from any blood borne disease e.g. HIV, Hep B

Primary outcomes:
measure: Baseline level and change in hunger ratings
timeFrame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
measure: Baseline level and change in fullness ratings
timeFrame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
measure: Baseline level and change in desire to eat ratings
timeFrame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
measure: Baseline level and change in prospective food consumption ratings
timeFrame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
measure: Baseline level and change in thirst ratings
timeFrame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
measure: Energy Intake
timeFrame: 20 minutes after the preload
measure: Baseline level and change in salivary properties
timeFrame: 90 minutes, 150 minutes, 170 minutes
Secondary outcomes:
measure: Palatibility of the preloads
timeFrame: Immediately after eating the preload
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
References: