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

Not Applicable

Completed

• Conditions: Postprandial Glucose and Insulin Response
• Interventions: Other: 40 grams of starch; Other: 80 grams of starch

• Registration Number: NCT03974126
• Lead Sponsor: Lund University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-30
• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Primary Completion: 2019-09-19
• Study Completion: 2019-11-15
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
40 grams of starch to low and high AMY1 copy number carriers	40 grams of starch	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
80 grams of starch to low and high AMY1 copy number carriers	80 grams of starch	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

Primary Outcome Measures

Name	Time	Method
Postprandial insulin	AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes)	postprandial insulin concentration assessed as incremental area under curve over 120 minutes (0, 7, 15, 30, 45, 60 ,90, 120 minutes)
Postprandial glucose	AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes)	Postprandial glucose concentration assessed as incremental area under curve over 120 minutes (0, 7, 15, 30, 45, 60 ,90, 120 minutes)
Preabsorptive insulin release	7 minutes	Insulin concentration at 7 minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lund University; 🇸🇪 Lund, Sweden