NCT03711084

Brief Summary

This study aims to examine potential differences in neurocognitive responses to food-related cues, physiological and appetite responses as well as subsequent energy intake following the consumption of preloads differing in sweetness and/ or postprandial metabolic effects in healthy normal weight subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

October 8, 2018

Last Update Submit

February 12, 2019

Conditions

Keywords

non-nutritive sweetenerssucrosefood-cue responsesappetiteblood glucoseenergy intake

Outcome Measures

Primary Outcomes (4)

  • Energy intake

    Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects energy intake (kcal) in healthy lean individuals.

    1 hour

  • Appetite ratings

    Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects appetite ratings (VAS scales) in healthy lean individuals.

    1 hour

  • Food-cue responses

    Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects food-cue responses (reaction times) in healthy lean individuals.

    1 hour

  • Blood glucose levels

    Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects blood glucose levels (mmol/L) in healthy lean individuals.

    1 hour

Secondary Outcomes (1)

  • Hedonic ratings

    1 hour

Study Arms (5)

Water

PLACEBO COMPARATOR

Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Dietary Supplement: Water

Natural high potency sweetener from leaf extract

EXPERIMENTAL

Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Dietary Supplement: Natural high potency sweetener from leaf extract

Glucose

EXPERIMENTAL

Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Dietary Supplement: Glucose

Sucrose

EXPERIMENTAL

Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Dietary Supplement: Sucrose

Maltodextrin

EXPERIMENTAL

Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Dietary Supplement: Maltodextrin

Interventions

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

Natural high potency sweetener from leaf extract
GlucoseDIETARY_SUPPLEMENT

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

Glucose
SucroseDIETARY_SUPPLEMENT

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

Sucrose
MaltodextrinDIETARY_SUPPLEMENT

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

Maltodextrin
WaterDIETARY_SUPPLEMENT

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

Water

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 - 40 years
  • BMI between 18.5-24.9 kg/m2
  • DEBQ for restraint eating ≤ 3
  • Healthy - general good health
  • Currently not taking any medication (other than females taking the oral contraceptives)
  • Normal or corrected vision
  • Regular breakfast eaters (≥5 times per week)
  • Stable weight, ≤ 5 kg last 12 months
  • Fasting blood glucose ≤6.0 mmol/L
  • No self-reported food allergy or intolerance to foods supplied during the study
  • The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • The participant is able to read, comprehend and record information written in English.
  • A signed and dated written informed consent is obtained from the participant.

You may not qualify if:

  • Age under 18 years or over 40 years old.
  • BMI ≥25 kg/m2 and \<18.5kg/m2
  • Subjects who are currently on a diet
  • Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Vegetarian Diet, Raw Food Diet etc.
  • Subjects having breakfast fewer than 5 times per week.
  • Vegetarians, vegans.
  • Presence of any chronic condition requiring medication that might affect our results (e.g. diabetes, mental diseases, gastrointestinal diseases)
  • Subjects with eating disorders (binge eating disorder, bulimia etc)
  • Subjects who are currently experiencing anxiety or depression.
  • Subjects who do not have normal vision and do not correct it with glasses or contact lenses.
  • Participants who drink more than the NHS guidelines (14 units per week)
  • Female participants who are, or may be, pregnant, or currently lactating.
  • Subjects who regularly consume dietary supplements for weight loss, muscle building etc.
  • Subjects who have aversions to foods related with the study.
  • Subjects with food allergies or intolerance related with the foods/ drinks of the study.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Related Publications (1)

  • Stamataki NS, Scott C, Elliott R, McKie S, Bosscher D, McLaughlin JT. Stevia Beverage Consumption prior to Lunch Reduces Appetite and Total Energy Intake without Affecting Glycemia or Attentional Bias to Food Cues: A Double-Blind Randomized Controlled Trial in Healthy Adults. J Nutr. 2020 May 1;150(5):1126-1134. doi: 10.1093/jn/nxaa038.

MeSH Terms

Conditions

Obesity

Interventions

GlucoseSucrosemaltodextrinWater

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesDisaccharidesOligosaccharidesPolysaccharidesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 18, 2018

Study Start

April 26, 2018

Primary Completion

October 15, 2018

Study Completion

November 15, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations