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Completed

NCT Number: NCT02097927

The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leatherhead Food Research Nutrition Unit

Leatherhead, Surrey, KT22 7RY, United Kingdom

About this study

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 (plus one screening visit) before and after repeated exposures to the beverages at home. The order in which participants receive the beverages will be counterbalanced and randomised. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations. Participants will fast overnight before each visit and consume the same evening meal before each test day. Participants will be instructed to avoid consuming food or calorific beverages for one hour before or after consuming the beverage. Following the last satiety testing day participants will be debriefed and open questions will be asked about experiences of the beverages in a focus group format.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Mango-flavour beverage

Behavioral

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.

Primary outcomes

  1. Change in energy intake

    Time frame: Weeks 0,3,5,8,10 and 13

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

Secondary outcomes

  1. Change in subjective appetite ratings

    Time frame: Weeks 0,3,5,8,10 and 13

    Change in subjective feelings of appetite assessed with Visual Analogue Scales (VAS). These will be measured on each of the 6 test days, which will occur before and after the repeated exposure period for each of the 3 beverage products.

Other outcomes

  1. Biomarkers of appetite in saliva samples

    Time frame: Weeks 0,3,5,8,10 and 13

    Frozen saliva samples will be banked. On completion of the study saliva samples associating with the extremes of appetite rating or energy intake will be pooled (6-12 samples / pool) and the protein component analysed by quantitative proteomics using an isobaric tags for relative and absolute quantitation (iTRAQ) workflow. Remaining samples will be retained for validation of proteins found to associate or predict appetite or energy intake.

Sponsors and collaborators

Lead sponsor

Leatherhead Food Research

Industry

Collaborators

  • University of Sussex

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 27, 2014
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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