Healthy Subjects Clinical Trial
Official title:
The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures
Verified date | August 2014 |
Source | Leatherhead Food Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leatherhead Food Research Nutrition Unit | Leatherhead | Surrey |
Lead Sponsor | Collaborator |
---|---|
Leatherhead Food Research | University of Sussex |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Biomarkers of appetite in saliva samples | 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. | Weeks 0,3,5,8,10 and 13 | No |
Primary | 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 | No |
Secondary | Change in subjective appetite ratings | 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. | Weeks 0,3,5,8,10 and 13 | No |
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