The Effects of Rye Crisp Bread on Appetite and Metabolic Function

Study Overview
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Brief Summary
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The aim of this study is to contribute to a better understanding of how dietary fibre in rye affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We will also investigate microstructural properties of the crisp breads with microscopy, as well as to characterize the food products with respect to the content of dietary fibre and certain bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are related to changes in insulin and glucose levels, appetite related hormonal signals and microstructural properties to verify findings from previous studies.

Detailed Description
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The short-term effects (up to 4 hours after intake) of rye crisp breads on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume three different breakfasts consisting of two different rye crisp breads and one wheat crisp bread on three different occasions separated by a 1 week wash-out period. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analogue scale (VAS) every 30 min during a 4-hour period, starting 30 min before breakfast. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose, insulin and hormone levels. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Glucose and hormonal responses will be related to subjective appetite and to differences in composition of the breakfasts.

Official Title
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The Effects of Rye Crisp Bread on Subjective Appetite and Metabolic Function After Short-term Consumption

Conditions
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Appetite Regulation

Intervention / Treatment
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* Other: Rye crisp bread A
* Other: Rye crisp bread B
* Other: Wheat crisp bread C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Habitual breakfast eaters Exclusion Criteria: 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 with eating Food intolerance/allergies to foods included in the study Intolerance/allergy to paracetamol Heavy smokers Recent or concurrent participation in a dietary intervention research study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rye crisp bread A<br> | Other: Rye crisp bread B<br>* In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.<br>Other: Wheat crisp bread C<br>* In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.<br>|
| Experimental: Rye crisp bread B<br> | Other: Rye crisp bread A<br>* In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.<br>Other: Wheat crisp bread C<br>* In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.<br>|
| Experimental: Wheat crisp bread C<br> | Other: Rye crisp bread A<br>* In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.<br>Other: Rye crisp bread B<br>* In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Appetite Profiles during 4 hours | Subjective feelings of appetite (satiety, hunger and desire to eat) assessed by visual analogue scale (VAS). | -30, 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric Emptying Rate during 4 hours | Paracetamol (1 g) taken with breakfast. The appearance of paracetamol in the blood is directly related to the rate of gastric emptying. | -15, 15, 35, 65, 95, 125, 185, 230 minutes | 
| Hormonal Responses during 4 hours | 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. | -15, 15, 35, 65, 95, 125, 185, 230 minutes | 
| Glucose and Insulin Responses during 4 hours | Glucose and insulin are measured in plasma samples. | -15, 15, 35, 65, 95, 125, 185, 230 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rye, Dietary Fibre, Bread, Crisp bread, Appetite, Satiety, Hunger, Desire to eat, Metabolism, Glucose, Insulin, Gut hormones, Gastric emptying rate