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Effect of Lubricity of Food Gels on Satiation and Satiety

U

University of Leeds

Status

Completed

Conditions

Appetitive Behavior

Treatments

Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beads

Study type

Interventional

Funder types

Other

Identifiers

NCT04240795
LUBSAT (18-049)

Details and patient eligibility

About

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.

Full 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).

Enrollment

17 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • With a normal weight (BMI=18.5 - 24.99 kg/m²)
  • Generally healthy

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

17 participants in 3 patient groups, including a placebo group

Low lubricity (LL) hydrogels containing fibre-based beads
Experimental group
Description:
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".
Treatment:
Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beads
High lubricity (HL) hydrogels containing no fibre-based beads
Active Comparator group
Description:
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".
Treatment:
Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beads
Water
Placebo Comparator group
Description:
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".
Treatment:
Dietary Supplement: Low lubricity (LL) hydrogels containing fibre-based beads

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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