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

NCT04868461 | Completed

• 2 other identifiers: LUBSAT (18-049) - Protein757993
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Appetitive Behavior

Keywords

Lubrication; protein; satiety; appetite control; food intake; salivary biomarkers

Outcome Measures

Primary Outcomes (9)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

• 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

• 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 Outcomes (1)

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

  Immediately after eating the preload.

Study Arms (4)

Unheated whey protein (UWP)

ACTIVE COMPARATOR

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".

Dietary Supplement: Unheated Whey Protein (UWP) beverage

Heated whey protein (HWP)

ACTIVE COMPARATOR

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".

Dietary Supplement: Heated Whey Protein (HWP) beverage

Casein (Cas)

ACTIVE COMPARATOR

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".

Dietary Supplement: Casein (Cas) beverage

Water

PLACEBO COMPARATOR

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.

Dietary Supplement: Water

Interventions

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.

Unheated whey protein (UWP)

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.

Heated whey protein (HWP)

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.

Casein (Cas)

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.

Water

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-55 years old
• With a BMI between 18.5 - 27.99 kg/m²)
• Generally healthy

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Beverages; Caseins; Crk-Associated Substrate Protein; Water

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins; Adaptor Proteins, Signal Transducing; Intracellular Signaling Peptides and Proteins; Peptides; Carrier Proteins; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study i.e. participants do not know the real purpose of the study. They are given a cover story. They are told about the real purpose of the study at the completion of this.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Colloids and Surfaces

Model Details: Tightly controlled cross-over study design with four arms.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 3, 2021
• Study Start: April 13, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)