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

NCT ID: NCT03974126

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2019-11-15

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.

Detailed Description

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Conditions

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Postprandial Glucose and Insulin Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants with low and high copy numbers of AMY1 were randomized to either 40 or 80 grams of starch in a crossover design.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

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

Study Groups

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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

Group Type EXPERIMENTAL

40 grams of starch

Intervention Type OTHER

40 grams of starch in form of white bread to be consumed within 15 minutes

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

Group Type EXPERIMENTAL

80 grams of starch

Intervention Type OTHER

80 grams of starch in form of white bread to be consumed within 15 minutes

Interventions

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40 grams of starch

40 grams of starch in form of white bread to be consumed within 15 minutes

Intervention Type OTHER

80 grams of starch

80 grams of starch in form of white bread to be consumed within 15 minutes

Intervention Type OTHER

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 34789141 (View on PubMed)

Other Identifiers

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Dnr 2018/968

Identifier Type: -

Identifier Source: org_study_id

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