Effect of Lubricity of Food Gels on Satiation and Satiety

Appetitive Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04240795
• Other study ID #: LUBSAT (18-049)
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 31, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior

Intervention

Dietary Supplement:
• Low 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.

Locations

Country	Name	City	State
United Kingdom	University of Leeds	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline level and change in hunger ratings	A 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).	-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
Primary	Baseline level and change in fullness ratings	A 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).	-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
Primary	Baseline level and change in desire to eat ratings	A 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)	-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
Primary	Baseline level and change in prospective food consumption ratings	A 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).	-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
Primary	Baseline level and change in thirst ratings	A 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).	-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
Primary	Energy Intake	The 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.	20 minutes after the preload
Primary	Baseline level and change in salivary properties	Saliva is collected on three time points on each visit. Salivary protein, amylase, mucin and statherin will be analysed and salivary lubricity will be mesaured	90 minutes, 150 minutes, 170 minutes
Secondary	Palatibility of the preloads	The 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".	Immediately after eating the preload