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

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Glucose and Insulin Response
• Intervention / Treatment: Other: 40 grams of starch; Other: 80 grams of starch

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22100
    • Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 40 grams of starch to low and high AMY1 copy number carriers; 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; 40 grams of starch in form of white bread to be consumed within 15 minutes
Experimental: 80 grams of starch to low and high AMY1 copy number carriers; 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; 80 grams of starch in form of white bread to be consumed within 15 minutes

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	weight will be measured	0 minutes

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: University of Copenhagen

Publications and helpful links

General Publications

• Farrell M, Ramne S, Gouinguenet P, Brunkwall L, Ericson U, Raben A, Nilsson PM, Orho-Melander M, Granfeldt Y, Tovar J, Sonestedt E. Effect of AMY1 copy number variation and various doses of starch intake on glucose homeostasis: data from a cross-sectional observational study and a crossover meal study. Genes Nutr. 2021 Nov 17;16(1):21. doi: 10.1186/s12263-021-00701-8.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): September 19, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Dnr 2018/968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No