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Effect of Lubricity of Food Gels on Satiation and Satiety

The Effects of Hydrogels Differing in Their Lubricity on Appetite Control, Satiety, Subsequent Food Intake and Salivary Biomarkers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04240795
Enrollment
17
Registered
2020-01-27
Start date
2019-11-01
Completion date
2020-07-31
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appetitive Behavior

Keywords

Food Structure, Gel, Satiety, Appetite, Food intake, Salivary biomarkers, Mucin, Amylase, Hunger, Fullness

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).

Interventions

DIETARY_SUPPLEMENTLow lubricity (LL) hydrogels containing fibre-based beads

The preload is made from kappa-carrageenan and alginate beads of 450 μm size. It contains no additional macronutrient but has food-grade watermelon flavor, color, and non-nutritive sweetener.

Sponsors

University of Leeds
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

Tightly controlled cross-over study design with three arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Baseline level and change in salivary properties90 minutes, 150 minutes, 170 minutesSaliva is collected on three time points on each visit. Salivary protein, amylase, mucin and statherin will be analysed and salivary lubricity will be mesaured
Baseline level and change in hunger ratings-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutesA questionnaire assessing perceived hunger is completed at specific times points throughout each of the 3.5-hours testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks : How hungry do you feel right now? with anchors of not all to extremely. The range is 0 mm (min hunger) and 100 is (max hunger).
Baseline level and change in fullness ratings-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutesA questionnaire assessing perceived fullness is completed at specific time points throughout each of the 3.5-hours testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: How full do you feel right now? with anchors of not all to extremely. The range is 0 mm (min fullness) and 100 is (max fullness).
Baseline level and change in desire to eat ratings-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutesA questionnaire assessing perceived desire to eat is completed at specific time points throughout each of the 3.5-hours testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: How strong is your desire to eat right now? with anchors of not all to extremely. The range is 0 mm (min desire to eat) and 100 is (max desire to eat)
Baseline level and change in prospective food consumption ratings-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutesA questionnaire assessing perceived prospective food consumption is completed at specific time points throughout each of the 3.5-hours testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: How much food do you think you could eat right now? with anchors of not all to extremely. The range is 0 mm (min prospective food consumption) and 100 is (max prospective food consumption).
Baseline level and change in thirst ratings-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutesA questionnaire assessing perceived thirst is completed at specific time points throughout each of the 3.5-hours testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: How thirsty do you feel right now? with anchors of not all to extremely. The range is 0 mm (min thirst) and 100 is (max thirst).
Energy Intake20 minutes after the preloadThe participants are provided with an ad libitum lunch of rice and vegetables, strawberry yogurt water. The amount of lunch is provided (in grams) and is weighted prior to consumption and any remains are re-weighted after consumption. Energy consumed will be calculated.

Secondary

MeasureTime frameDescription
Palatibility of the preloadsImmediately after eating the preloadThe palatability of both the hydrogels and water are assessed through a 100 mm VAS scale. Within the palatability the ratings are taking on following attributes: the texture, flavor and sweetness. The questions asked are: How much did you like the texture of the product you have just eaten?, How much did you like the flavor of the product you have just eaten?, How intense was the sweet taste of the product you have just eaten? with anchors from not at all to extremely.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026