- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04240795
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
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS2 9JT
- University of Leeds
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low lubricity (LL) hydrogels containing fibre-based beads
Participants are given a preload of 30 g of low lubricity hydrogels (alginate beads in kappa-carrageenan hydrogels) after 2.5 hours after a standardized breakfast.
After 30 minutes of the preload, participants are given ad libitum lunch.
They are asked to eat "as much or as little as they want, until they feel comfortably full".
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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.
Other Names:
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Active Comparator: High lubricity (HL) hydrogels containing no fibre-based beads
Participants are given a preload of 30 g of high lubricity hydrogels (no beads in kappa-carrageenan and alginate mixed hydrogels) after 2.5 hours after a standardized breakfast.
After 30 minutes of the preload, participants are given ad libitum lunch.
They are asked to eat "as much or as little as they want, until they feel comfortably full".
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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.
Other Names:
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Placebo Comparator: Water
The water containing the same watermelon flavor, color and sweetness was given as control to match the gels.
Participants receive the same amount of water like hydrogels - 30 g after 2.5 hours after a standardized breakfast.
After 30 minutes of the preload, participants are given ad libitum lunch.
They are asked to eat "as much or as little as they want, until they feel comfortably full".
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline level and change in hunger ratings
Time Frame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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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).
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-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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Baseline level and change in fullness ratings
Time Frame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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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).
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-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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Baseline level and change in desire to eat ratings
Time Frame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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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)
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-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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Baseline level and change in prospective food consumption ratings
Time Frame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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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).
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-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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Baseline level and change in thirst ratings
Time Frame: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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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).
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-5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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Energy Intake
Time Frame: 20 minutes after the preload
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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.
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20 minutes after the preload
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Baseline level and change in salivary properties
Time Frame: 90 minutes, 150 minutes, 170 minutes
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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
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90 minutes, 150 minutes, 170 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Palatibility of the preloads
Time Frame: Immediately after eating the preload
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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".
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Immediately after eating the preload
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LUBSAT (18-049)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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