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OpenTrials
Completed

NCT Number: NCT03974126

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.

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Key information

Conditions

Postprandial Glucose and Insulin Response

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University

Lund, 22100, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

40 grams of starch

Other

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

80 grams of starch

Other

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

Primary outcomes

  1. Postprandial glucose

    Time frame: 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)

  2. Postprandial insulin

    Time frame: 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)

  3. Preabsorptive insulin release

    Time frame: 7 minutes

    Insulin concentration at 7 minutes

Secondary outcomes

  1. subjective satiety

    Time frame: 0, 15, 30, 45, 60, 90, 120 minutes

    Visual analog scales (VAS) to evaluate hunger and satiety

  2. salivary amylase activity

    Time frame: 0 minutes

    Salivary amylase activity will be measured by ELISA kits

Other outcomes

  1. weight

    Time frame: 0 minutes

    weight will be measured

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.