NCT04240795

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

January 15, 2020

Last Update Submit

August 11, 2020

Conditions

Appetitive Behavior

Keywords

Food StructureGelSatietyAppetiteFood intakeSalivary biomarkersMucinAmylaseHungerFullness

Outcome Measures

Primary Outcomes (7)

  • Baseline level and change in hunger ratings

    A questionnaire assessing perceived hunger is completed at specific times points throughout each of the 3.5-hours 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 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes

  • Baseline level and change in fullness ratings

    A questionnaire assessing perceived fullness is completed at specific time points throughout each of the 3.5-hours 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 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes

  • Baseline level and change in desire to eat ratings

    A questionnaire assessing perceived desire to eat is completed at specific time points throughout each of the 3.5-hours 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 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 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 3.5-hours 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 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes

  • Baseline level and change in thirst ratings

    A questionnaire assessing perceived thirst is completed at specific time points throughout each of the 3.5-hours 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 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 160 minutes, 170 minutes, 180 minutes, 190 minutes, 225 minutes

  • Energy Intake

    The participants are provided with an ad libitum lunch of rice and vegetables, strawberry yogurt water. The amount of lunch is provided (in grams) and is weighted prior to consumption and any remains are re-weighted after consumption. Energy consumed will be calculated.

    20 minutes after the preload

  • Baseline level and change in salivary properties

    Saliva is collected on three time points on each visit. Salivary protein, amylase, mucin and statherin will be analysed and salivary lubricity will be mesaured

    90 minutes, 150 minutes, 170 minutes

Secondary Outcomes (1)

  • Palatibility of the preloads

    Immediately after eating the preload

Study Arms (3)

Low lubricity (LL) hydrogels containing fibre-based beads

EXPERIMENTAL

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".

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

High lubricity (HL) hydrogels containing no fibre-based beads

ACTIVE COMPARATOR

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".

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

Water

PLACEBO COMPARATOR

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".

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

Interventions

Low lubricity (LL) hydrogels containing fibre-based beadsDIETARY_SUPPLEMENT

The preload is made from kappa-carrageenan and alginate beads of 450 μm size. It contains no additional macronutrient but has food-grade watermelon flavor, color, and non-nutritive sweetener.

Also known as: High lubricity (HL) hydrogels containing no fibre-based beads, Water
High lubricity (HL) hydrogels containing no fibre-based beadsLow lubricity (LL) hydrogels containing fibre-based beadsWater

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Appetitive BehaviorMedullary cystic kidney disease 1

Interventions

Water

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Tightly controlled cross-over study design with three arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 27, 2020

Study Start

November 1, 2019

Primary Completion

March 30, 2020

Study Completion

July 31, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)