Postprandial Effect of High-starch Meals in Individuals With Low and High Copy Number of the Salivary Amylase Gene

Study Overview
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Brief Summary
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Individuals with low copy numbers of salivary amylase gene have lower salivary amylase levels and might therefore have decreased capacity to metabolize starch into glucose. We will in a randomized crossover meal study examine the postprandial response of high-starch meals in individuals with either low or high copy number of the salivary amylase gene.

Official Title
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Postprandial Effect of High-starch Meals in Individuals With Low and High Copy Number of the Salivary Amylase Gene

Conditions
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Postprandial Glucose and Insulin Response

Intervention / Treatment
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* Other: 40 grams of starch
* Other: 80 grams of starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant in the Malmö Offspring Study Genotyped for AMY1 copy number variation and selected for having either low (2-4) or high (10 or above) copy number of AMY1 Gender: both males and females Completed information on dietary habits Exclusion Criteria: Allergic to wheat, gluten intolerant or on a low-carbohydrate diet Inability to eat up to 4 slices of white bread in 15 minutes Use of medication known to influence glucose metabolism, appetite or saliva flow Diagnosed diabetes or high fasting plasma glucose (above 6.1 mmol/L) Smoking

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants with low and high copy numbers of AMY1 were randomized to either 40 or 80 grams of starch in a crossover design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 40 grams of starch to low and high AMY1 copy number carriers<br>The postprandial response between individuals that are either carriers of low AMY1 copy numbers (2-4) or high copy numbers (10 or more copies) will be compared | Other: 40 grams of starch<br>* 40 grams of starch in form of white bread to be consumed within 15 minutes<br>|
| Experimental: 80 grams of starch to low and high AMY1 copy number carriers<br>The postprandial response between individuals that are either carriers of low AMY1 copy numbers (2-4) or high copy numbers (10 or more copies) will be compared | Other: 80 grams of starch<br>* 80 grams of starch in form of white bread to be consumed within 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose | Postprandial glucose concentration assessed as incremental area under curve over 120 minutes (0, 7, 15, 30, 45, 60 ,90, 120 minutes) | AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes) | 
| Postprandial insulin | postprandial insulin concentration assessed as incremental area under curve over 120 minutes (0, 7, 15, 30, 45, 60 ,90, 120 minutes) | AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes) | 
| Preabsorptive insulin release | Insulin concentration at 7 minutes | 7 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective satiety | Visual analog scales (VAS) to evaluate hunger and satiety | 0, 15, 30, 45, 60, 90, 120 minutes | 
| salivary amylase activity | Salivary amylase activity will be measured by ELISA kits | 0 minutes |