Appetite Regulation Clinical Trial
Official title:
The Combined Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function After Short-Term Consumption
Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products. The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein. The aim is also to try to elucidate how observed effects on subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients in the blood and products from bacterial fermentation of dietary fibre, and to relate this to the different composition of the breakfasts.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Women must be post-menopausal or habitually take hormonal contraceptives - Habitual breakfast eaters Exclusion Criteria: - Non-contraceptive use among pre-menopausal women - Pregnancy, lactation or wishing to become pregnant during the study period - Dieting - Weightloss - Eating disorder - Hyperglycemic - Hyperinsulinemic - Thyroid disease - Metabolic issues - Diabetes - Physical or psychological problems eating - Food intolerances/allergies to foods included in the study - Vegetarians - Intolerance/allergy to paracetamol - Heavy smokers - Recent or concurrent participation in an intervention research study |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Sweden | Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Swedish University of Agricultural Sciences | Uppsala University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective appetite profiles | Subjective feelings of appetite (satiety, hunger and desire to eat) are assessed by visual analogue scale (VAS) (in total 18 measurements). | 8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480) | No |
Secondary | Breath hydrogen and methane response | Measurements of the concentration of breath hydrogen and methane(in total 10 measurements). | 8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480) | No |
Secondary | Gastric emptying rate | Paracetamol (1 g) was taken with breakfast. The appearance of paracetamol in the blood is directly related to the rate of gastric emptying. | 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470) | No |
Secondary | Glucose and hormonal response | Glucose, insulin, glucagon, glucagon-like peptide-1 (GLP-1), glucose-dependent insulino-tropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), leptin and ghrelin are measured in plasma samples. | 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470) | No |
Secondary | Metabolic profiles | The flux of nutrients is measured in plasma samples. | 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470) | No |
Secondary | Products from bacterial fermentation of dietary fibre | Products from bacterial fermentation of dietary fibre are measured in plasma samples. | 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470) | No |
Secondary | Ad libitum food intake | Energy intakes will be assessed from the ad libitum dinner in order to validate subjective appetite measurements. | 8 h after breakfast (480 min) | No |
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