Effect of Oral Lubrication on Appetite, Food Intake and Salivary Biomarkers in Protein Beverages

Appetitive Behavior Clinical Trial

— LubSat  

Official title:

Effects of Protein Beverages Differing in Their Lubricating Properties on Appetite Control, Subsequent Food Intake and Salivary Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04868461
• Other study ID #: LUBSAT (18-049) - Protein
• Secondary ID: 757993
• Status: Completed
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: November 2022
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of this study is to elucidate the influence of protein beverages differing in their lubrication properties (low/medium/high lubricating) and control (water) on satiety and satiation.

Description:

The researchers propose an acute, randomized cross-over study that compares three types of protein beverages differing in their lubricating properties, i.e. one with low lubricating properties made using sodium caseinate, one with medium lubricating properties made by whey protein, and the third one with high lubricating properties made by heated whey protein. All three beverages contain added banana flavour and non-nutritive sweetener. Water acts as a control and has the same flavour and sweetness to match those of the protein beverages.

Participants are asked to come to the laboratory on four 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 four treatments (water or either of the three protein beverages), 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. Each session lasts 1.5 hours (8.40 am until 10.10 pm). In the first session, weight and height are measured. Participants then provide baseline (- 5 min) appetite ratings on a 100 mm visual analogue scale (VAS). After that they are given the preload - either protein beverages differing in their lubricating properties or water. Then, participants are asked to rate their appetite on a 100-mm VAS every 10 minutes for the next 30 minutes. Ad libitum food is offered as breakfast after 30 min after ingesting the preload and the last VAS is taken. Saliva is taken three times during each session before preload, after preload consumption and before ad libitum breakfast.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Adults aged 18-55 years old

• With a BMI between 18.5 - 27.99 kg/m²)

• Generally healthy

Exclusion Criteria:

• have any blood borne disease;

• have type-1 or type-2 diabetes;

• have liver and kidney disease;

• have past history of gastrointestinal surgery;

• are a smoker;

• have oral infections/ diseases;

• have chronic or acute health condition that may affect ability to sense, eat, digest, absorb or excrete food;

• have a sensitive stomach (Irritable Bowel Stomach);

• are currently using prescribed or non-prescribed medication;

• are pregnant or lactating;

• are suffering from an illness, feeling unwell, having fever, or cold or cough;

• history of food allergy or intolerance;

• are on any special diet or are taking protein and/or fibre supplements;

• cannot tolerate protein beverages;

• present any COVID related symptoms (high temperature, a new continuous cough, a loss or change to your smell or taste);

• if you are self-isolating or if you leave with someone self-isolating or presenting COVID related symptoms.

Related Conditions & MeSH terms

• Appetitive Behavior

Intervention

Dietary Supplement:
• Unheated Whey Protein (UWP) beverage
The preload is made from whey protein powder. The energy load of the preload is 119.7 kcal and has banana flavor and sweetener.
• Heated Whey Protein (HWP) beverage
The preload is made from whey protein powder of 95% and it is heated for a certain amount of time. The energy load of the preload is 119.7 kcal and has banana flavor and sweetener.
• Casein (Cas) beverage
The preload is made from casein powder. The energy load of the preload is 105 kcal and has banana flavor and sweetener.
• Water
The preload is water acting as a control and contain the same banana flavor and sweetener to match the other three intervention - protein beverages.

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 1.5-h 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 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Primary	Baseline level and change in fullness ratings	A questionnaire assessing perceived fullness is completed at specific times points throughout each of the 1.5-h 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 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Primary	Baseline level and change in desire to eat ratings	A questionnaire assessing perceived desire to eat is completed at specific times points throughout each of the 1.5-h 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 minute, 10 minutes, 20 minutes, 30 minutes, 50 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 1.5-h 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 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Primary	Baseline level and change in thirst ratings	A questionnaire assessing perceived thirst is completed at specific time points throughout each of the 1.5-h 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 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Primary	Baseline level and change in breakfast energy intake	The participants are provided with an ad libitum breakfast of cereals and milk, tea/coffee (at participant choice) and water. The amount of breakfast is provided (in grams) and is weighted prior to consumption and any remains are re-weighted after consumption. Energy consumed will be calculated. Participants are given 15 minutes for consuming the breakfast.	-5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Primary	Baseline level and change in salivary protein	Saliva is collected on three time points on each visit. Salivary protein will be analyzed to determine the relationship between these components that affect oral lubrication and satiety and satiation.	-5 minutes, 20 minutes, 50 minutes
Primary	Baseline level and change in salivary amylase	Saliva is collected on three time points on each visit. Salivary amylase will be analyzed to determine the relationship between these components that affect oral lubrication and satiety and satiation.	-5 minutes, 20 minutes, 50 minutes
Primary	Baseline level and change in salivary mucin	Saliva is collected on three time points on each visit. Salivary mucin will be analyzed to determine the relationship between these components that affect oral lubrication and satiety and satiation.	-5 minutes, 20 minutes, 50 minutes,
Secondary	Liking and wanting of the preload using Visual Analogue Scale (VAS)	Liking and wanting of both the protein beverages and water are assessed through a 100 mm VAS scale where 0 means "not at all" and 100 means "extremely". Within the liking the ratings are taking on following attributes: the texture, flavor, sweetness and overall liking/pleasantness. The questions asked are: "How much did you like the texture of the product you have just consumed?", "How much did you like the flavor of the product you have just consumed?", How intense was the sweet taste of the product you have just consumed?", "How pleasant was the product you have just consumed? "with anchors from "not at all" to "extremely". And for the wanting assessment the question is: "How much did you want to consume the product you have just had?" with anchors from "not at all" to "extremely".	Immediately after eating the preload.