NCT02097927

Brief Summary

The study will be a 3-way crossover design: it will assess the impact of consuming a beverage enhanced with satiety-relevant properties on subjective ratings of appetite and on energy intake compared with a low energy version with the same sensory characteristics, and a non-sensory enhanced high energy control. In addition, saliva samples will be collected at regular intervals for the identification of novel biomarkers of energy intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

March 19, 2014

Last Update Submit

August 6, 2014

Conditions

Healthy Subjects

Keywords

AppetiteSatietyEnergy intakeSalivaBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Change in energy intake

    Change in intake (kcals) at an ad libitum lunch, assessed before and after the repeated exposure period for each of the 3 beverage products

    Weeks 0,3,5,8,10 and 13

Secondary Outcomes (1)

  • Change in subjective appetite ratings

    Weeks 0,3,5,8,10 and 13

Other Outcomes (1)

  • Biomarkers of appetite in saliva samples

    Weeks 0,3,5,8,10 and 13

Study Arms (3)

High energy, low sensory

EXPERIMENTAL

Mango-flavour beverage

Behavioral: Mango-flavour beverage

Low energy, high sensory

EXPERIMENTAL

Mango-flavour beverage

Behavioral: Mango-flavour beverage

High energy, high sensory beverage

EXPERIMENTAL

Mango-flavour beverage

Behavioral: Mango-flavour beverage

Interventions

Mango-flavour beverageBEHAVIORAL

The study will be a 3-way crossover design: it will assess the impact of a high-energy, sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages following repeated exposures. Each participant will consume each beverage 10 times. This includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions consuming the product as a mid-morning snack during the participants' normal routine. Each participant will attend the Nutrition Unit on 6 different occasions before and after repeated exposures to the beverages at home. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations.

High energy, high sensory beverageHigh energy, low sensoryLow energy, high sensory

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gender: male or female
  • Age at start of the study ≥ 18 and ≤ 65 years
  • Body Mass Index (BMI) ≥ 18 and ≤ 29.9 kg/m2
  • Apparently healthy: measured by questionnaire (APPENDIX 3): no reported current or previous metabolic diseases or chronic gastrointestinal disorders
  • Reported dietary habits: no medically prescribed diet, no slimming diet, used to eating 3 meals a day
  • Reported intense sporting activities ≤ 10h/w
  • Reported alcohol consumption ≤14 units/w
  • Informed consent signed
  • Recruitment form filled out

You may not qualify if:

  • Smoking
  • Dislike, allergy or intolerance to test products or study meals
  • Possible eating disorder (measured by SCOFF questionnaire score \>1)
  • Reported medical treatment that may affect eating habits/satiety
  • Eating habits questionnaire score \>14
  • Reported participation in another biomedical trial 1 month before the start of the study
  • Food allergies or intolerance to ad libitum meals
  • Pregnant and/or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leatherhead Food Research Nutrition Unit

Leatherhead, Surrey, KT22 7RY, United Kingdom

Location

Study Officials

  • Roberta Re, PhD

    Leatherhead Food Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 27, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations

GB(1)