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

Sponsor

Lund University (Other)

Overall Status

Completed

CT.gov ID

NCT03974126

Collaborator

University of Copenhagen (Other)

Enrollment

Location

Arms

6.5

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postprandial Glucose and Insulin Response	Other: 40 grams of starch Other: 80 grams of starch	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Genotype were blinded for the participants and all research staff except for the principal investigator. Amount of bread was not blinded.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 30, 2019

Actual Primary Completion Date :

Sep 19, 2019

Actual Study Completion Date :

Nov 15, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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)
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)
Preabsorptive insulin release [7 minutes]
Insulin concentration at 7 minutes

Secondary Outcome Measures

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

Other Outcome Measures

weight [0 minutes]
weight will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lund University	Lund		Sweden	22100

Sponsors and Collaborators

Lund University
University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lund University

ClinicalTrials.gov Identifier:

NCT03974126

Other Study ID Numbers:

Dnr 2018/968

First Posted:

Jun 4, 2019

Last Update Posted:

Jan 18, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 18, 2020