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Completed

NCT Number: NCT04868461

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

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.

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Key information

Conditions

Appetitive Behavior Behavior Behavior, Animal

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unheated Whey Protein (UWP) beverage

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

The preload is made from casein powder. The energy load of the preload is 105 kcal and has banana flavor and sweetener.

Water

Dietary Supplement

The preload is water acting as a control and contain the same banana flavor and sweetener to match the other three intervention - protein beverages.

Primary outcomes

  1. Baseline level and change in hunger ratings

    Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.

    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).

  2. Baseline level and change in fullness ratings

    Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.

    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).

  3. Baseline level and change in desire to eat ratings

    Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.

    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).

  4. Baseline level and change in prospective food consumption ratings

    Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.

    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. Baseline level and change in thirst ratings

    Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.

    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).

  6. Baseline level and change in breakfast energy intake

    Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.

    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.

  7. Baseline level and change in salivary protein

    Time frame: -5 minutes, 20 minutes, 50 minutes

    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.

  8. Baseline level and change in salivary amylase

    Time frame: -5 minutes, 20 minutes, 50 minutes

    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.

  9. Baseline level and change in salivary mucin

    Time frame: -5 minutes, 20 minutes, 50 minutes,

    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.

Secondary outcomes

  1. Liking and wanting of the preload using Visual Analogue Scale (VAS)

    Time frame: Immediately after eating the preload.

    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".

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Official study title

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

Acronym: LubSat

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 3, 2021
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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