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

University of Leeds

Status: Completed

Conditions: Appetitive Behavior

Treatments: Dietary Supplement: Water; Dietary Supplement: Heated Whey Protein (HWP) beverage; Dietary Supplement: Casein (Cas) beverage; Dietary Supplement: Unheated Whey Protein (UWP) beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT04868461

757993 (Other Grant/Funding Number)

LUBSAT (18-049) - Protein

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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52 participants in 4 patient groups, including a placebo group

Unheated whey protein (UWP)

Active Comparator group

Description:

Participants are given a preload of 200 mL of unheated whey protein (UWP) in the morning, on a fasting state. After 30 minutes after the preload, participants are given ad libitum breakfast. They are asked to eat "as much or as little as they want, until they feel comfortably full".

Treatment:

Dietary Supplement: Unheated Whey Protein (UWP) beverage

Heated whey protein (HWP)

Active Comparator group

Description:

Participants are given a preload of 200 mL of heated whey protein (HWP) in the morning, on a fasting state. After 30 minutes after the preload, participants are given ad libitum breakfast. They are asked to eat "as much or as little as they want, until they feel comfortably full".

Treatment:

Dietary Supplement: Heated Whey Protein (HWP) beverage

Casein (Cas)

Active Comparator group

Description:

Participants are given a preload of 200 mL of Casein (Cas) in the morning, on a fasting state. After 30 minutes after the preload, participants are given ad libitum breakfast. They are asked to eat "as much or as little as they want, until they feel comfortably full".

Treatment:

Dietary Supplement: Casein (Cas) beverage

Water

Placebo Comparator group

Description:

The water has the same banana flavor and sweetness to match the protein beverages. Participants receive the same amount of water like protein beverages - 200mL.

Treatment:

Dietary Supplement: Water