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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03974126
Enrollment
23
Registered
2019-06-04
Start date
2019-04-30
Completion date
2019-11-15
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial Glucose and Insulin Response

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.

Interventions

OTHER40 grams of starch

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

OTHER80 grams of starch

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

Sponsors

University of Copenhagen
CollaboratorOTHER
Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, 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.

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.

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial glucoseAUC (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 insulinAUC (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 release7 minutesInsulin concentration at 7 minutes

Secondary

MeasureTime frameDescription
subjective satiety0, 15, 30, 45, 60, 90, 120 minutesVisual analog scales (VAS) to evaluate hunger and satiety
salivary amylase activity0 minutesSalivary amylase activity will be measured by ELISA kits

Other

MeasureTime frameDescription
weight0 minutesweight will be measured

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026