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

Postprandial Glucose and Insulin Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974126
• Other study ID #: Dnr 2018/968
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: January 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 15, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Postprandial Glucose and Insulin Response

Intervention

Other:
• 40 grams of starch
40 grams of starch in form of white bread to be consumed within 15 minutes
• 80 grams of starch
80 grams of starch in form of white bread to be consumed within 15 minutes

Locations

Country	Name	City	State
Sweden	Lund University	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	University of Copenhagen

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	weight	weight will be measured	0 minutes
Primary	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)
Primary	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)
Primary	Preabsorptive insulin release	Insulin concentration at 7 minutes	7 minutes
Secondary	subjective satiety	Visual analog scales (VAS) to evaluate hunger and satiety	0, 15, 30, 45, 60, 90, 120 minutes
Secondary	salivary amylase activity	Salivary amylase activity will be measured by ELISA kits	0 minutes