Obesity Clinical Trial
Official title:
The Impact of Dietary Sweetness on Neurocognitive Responses to Visual Food Cues, Appetite and Physiological Parameters on Normal Weight Adults: a Pilot Study
NCT number | NCT03711084 |
Other study ID # | 2310 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 26, 2018 |
Est. completion date | November 15, 2018 |
Verified date | February 2019 |
Source | University of Manchester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 15, 2018 |
Est. primary completion date | October 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Habitual NNS consumers, >1 can of diet beverage or >1 table packet of sweeteners per week. - Fasting blood glucose measured > 6 mmol/L at screening visit, according to diabetes.co.uk recommendations. - The participant cannot read, comprehend and record information written in English. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Manchester | Manchester |
Lead Sponsor | Collaborator |
---|---|
University of Manchester | Cargill |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Hedonic ratings | Examine how participants rate the hedonic attributes of the test beverages (Sweetness, pleasantness, etc) and the meal | 1 hour |
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