Postprandial Glucose and Insulin ResponseNCT03974126
Postprandial Effect of High-starch Meals in Individuals With Low and High Copy Number of the Salivary Amylase Gene
A study testing 40 grams of starch and 80 grams of starch in people with Postprandial Glucose and Insulin Response, run by Lund University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Postprandial Glucose and Insulin Response
- What is being tested?
- 40 grams of starch and 80 grams of starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- 30 Apr 2019to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- 40 grams of starch, 80 grams of starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 grams of starchOther
40 grams of starch in form of white bread to be consumed within 15 minutes
80 grams of starchOther
80 grams of starch in form of white bread to be consumed within 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| 40 grams of starch to low and high AMY1 copy number carriers | Experimental | 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 Receives: Other: 40 grams of starch |
| 80 grams of starch to low and high AMY1 copy number carriers | Experimental | 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 Receives: Other: 80 grams of starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose
Postprandial glucose concentration assessed as incremental area under curve over 120 minutes (0, 7, 15, 30, 45, 60 ,90, 120 minutes)
Measured: AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes)
Postprandial insulin
postprandial insulin concentration assessed as incremental area under curve over 120 minutes (0, 7, 15, 30, 45, 60 ,90, 120 minutes)
Measured: AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes)
Preabsorptive insulin release
Insulin concentration at 7 minutes
Measured: 7 minutes
Secondary outcomes (2)
subjective satiety
Visual analog scales (VAS) to evaluate hunger and satiety
Measured: 0, 15, 30, 45, 60, 90, 120 minutes
salivary amylase activity
Salivary amylase activity will be measured by ELISA kits
Measured: 0 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start30 Apr 2019
- Primary completion19 Sep 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial Glucose and Insulin ResponseStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974126
- Sponsor's protocol ID
- Dnr 2018/968
- Status last verified
- Jan 2020
- First submitted
- 24 May 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34789141
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Effect of High-starch Meals in Individuals With Low and High Copy Number of the Salivary Amylase Gene
- ClinicalTrials.gov ID
- NCT03974126
- Acronym / sponsor ID
- Dnr 2018/968
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 40 grams of starch to low and high AMY1 copy number carriers | Experimental | Other: 40 grams of starchThe 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 |
| 80 grams of starch to low and high AMY1 copy number carriers | Experimental | Other: 80 grams of starchThe 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 |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 grams of starch40 grams of starch in form of white bread to be consumed within 15 minutes | Other | 40 grams of starch to low and high AMY1 copy number carriers |
| 80 grams of starch80 grams of starch in form of white bread to be consumed within 15 minutes | Other | 80 grams of starch to low and high AMY1 copy number carriers |
Primary outcome
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)
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)
Preabsorptive insulin release
Time frame: 7 minutes
Insulin concentration at 7 minutes
2 secondary outcomes
subjective satiety
Time frame: 0, 15, 30, 45, 60, 90, 120 minutes
salivary amylase activity
Time frame: 0 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 34789141Farrell 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.
- Individual participant dataSharing planned: Undecided
Related trials for Postprandial Glucose and Insulin Response
Recruiting
Effects of Pistachios on Postprandial Metabolic Responses in Adults With Overweight or Obesity
Obesity / Overweight
Active, not recruiting
How Fig Polyphenols Affect Blood Sugar and Insulin Levels After Eating in Adults at Risk for Diabetes
Pre Diabetic
Not yet recruiting
Lipid and Glucose Response to Plant-based and Regular Burgers
Metabolic Syndrome
Not yet recruiting
Effects of Postprandial Walking and Resistance Snacking on Glucose Responses in Adults With Metabolic Syndrome
Metabolic Syndrome, Prediabetes
Not yet recruiting
A1-Free vs. Conventional Milk Metabolic Response Study
Postprandial Glucose Response, Insulin Response
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40 grams of starch and 80 grams of starch in people with Postprandial Glucose and Insulin Response, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose (time frame: AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.