Appetitive BehaviorNCT04240795
Effect of Lubricity of Food Gels on Satiation and Satiety
A study testing Low lubricity (LL) hydrogels containing fibre-based beads in people with Appetitive Behavior, run by University of Leeds at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Low lubricity (LL) hydrogels containing fibre-based beads
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- With a normal weight (BMI=18.5 - 24.99 kg/m²)
- Generally healthy
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: The Effects of Hydrogels Differing in Their Lubricity on Appetite Control, Satiety, Subsequent Food Intake and Salivary Biomarkers
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.
Read the 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).
- Conditions
- Appetitive Behavior
- Being tested
- Low lubricity (LL) hydrogels containing fibre-based beads
- Keywords
- Food Structure, Gel, Satiety, Appetite, Food intake, Salivary biomarkers, Mucin, Amylase, Hunger, Fullness
- Medical subject headings
- Appetitive Behavior, Medullary cystic kidney disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low lubricity (LL) hydrogels containing fibre-based beadsDietary supplement
Also called High lubricity (HL) hydrogels containing no fibre-based beads, Water
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.
| Study group | Role | What they receive |
|---|---|---|
| Low lubricity (LL) hydrogels containing fibre-based beads | Experimental | 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". Receives: Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beads |
| High lubricity (HL) hydrogels containing no fibre-based beads | Active comparator | 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". Receives: Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beads |
| Water | Placebo comparator | 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". Receives: Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beads |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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).
Measured: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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)
Measured: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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).
Measured: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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).
Measured: -5 minutes, 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes
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.
Measured: 20 minutes after the preload
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
Measured: 90 minutes, 150 minutes, 170 minutes
Secondary outcomes (1)
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".
Measured: Immediately after eating the preload
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Nov 2019
- Primary completion30 Mar 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Tightly controlled cross-over study design with three arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anwesha Sarkar, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240795
- Sponsor's protocol ID
- LUBSAT (18-049)
- Status last verified
- Aug 2020
- First submitted
- 15 Jan 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hydrogels Differing in Their Lubricity on Appetite Control, Satiety, Subsequent Food Intake and Salivary Biomarkers
- ClinicalTrials.gov ID
- NCT04240795
- Acronym / sponsor ID
- LUBSAT (18-049)
- Conditions
- Appetitive Behavior
- Keywords
- Food Structure, Gel, Satiety, Appetite, Food intake, Salivary biomarkers, Mucin, Amylase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Tightly controlled cross-over study design with three arms.
| Arm | Type | Receives |
|---|---|---|
| Low lubricity (LL) hydrogels containing fibre-based beads | Experimental | Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beadsParticipants 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". |
| High lubricity (HL) hydrogels containing no fibre-based beads | Active comparator | Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beadsParticipants 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". |
| Water | Placebo comparator | Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beadsThe 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". |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- With a normal weight (BMI=18.5 - 24.99 kg/m²)
- Generally healthy
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low lubricity (LL) hydrogels containing fibre-based beadsAlso: High lubricity (HL) hydrogels containing no fibre-based beads, WaterThe 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. | Dietary supplement | High lubricity (HL) hydrogels containing no fibre-based beads, Low lubricity (LL) hydrogels containing fibre-based beads, Water |
Primary outcome
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
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).
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
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).
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
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)
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
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).
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
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).
Energy Intake
Time frame: 20 minutes after the preload
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.
Baseline level and change in salivary properties
Time frame: 90 minutes, 150 minutes, 170 minutes
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
1 secondary outcome
Palatibility of the preloads
Time frame: Immediately after eating the preload
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low lubricity (LL) hydrogels containing fibre-based beads in people with Appetitive Behavior, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.