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

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ClinicalTrials.gov Identifier: NCT03974126
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Lund University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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.
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 : April 30, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. weight [ Time Frame: 0 minutes ]
    weight will be measured



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974126


Locations
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Sweden
Lund University
Lund, Sweden, 22100
Sponsors and Collaborators
Lund University
University of Copenhagen

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03974126     History of Changes
Other Study ID Numbers: Dnr 2018/968
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No