Postprandial HyperglycemiaAPRENCT06640335
The Effects of Vegetable Preloading on Postprandial Glycemia, Insulinaemia and Gastric Emptying
A study testing Co-ingestion, 0 min preload and 5 min preload in people with Postprandial Hyperglycemia and Insulin High, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The objective of this study is to investigate the importance of leavy vegetable preloading on the postprandial glycaemic and insulinemic response in human subjects when consumed a specific amount of digestible carbohydrate from Russet Burbank potatoes source. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Insulin High
- What is being tested?
- Co-ingestion, 0 min preload and 5 min preload
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Sep 2023to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal body mass index (18.5 kg/m2 to 24.9 kg/m2), weight >/= 45 kg
- Normal blood pressure </=120/80 mmH
- Fasting blood glucose of <5.6 mmol/l
- Able to provide written informed consent before participating in the study.
- Able to communicate adequately to comply with the requirements of the entire study, i.e., able to eat test meal and provide breath samples.
Who cannot join
- Smokers.
- Individuals with any metabolic diseases (such as diabetes, hypertension etc).
- Individuals with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency).
- Individuals with medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics).
- Individuals who take any prescribed medication or dietary supplements which may interfere with the study measurements.
- Individuals who have any major organ dysfunction (eg. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug.
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- Individuals with history of malabsorption due to mucosal disease, pancreatic disease, or other causes.
- Individuals with history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders).
- Individuals who are allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, sulphites etc.
- People who intentionally restrict food intake.
- People who consume excessive 13C rich products such as corn, sugar beet and pineapple.
- Individuals who partake in sports at the competitive and/or endurance levels
- Individuals who have any known chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV).
- Individuals who is a study team member or an immediate family of any study team member.
- Individuals who consume Excessive alcohol: consuming >/= 6 alcoholic drinks per week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Vegetable Preloading on Postprandial Glycemia, Insulinaemia and Gastric Emptying in Healthy Adults: A Randomized Cross-over Trial
The objective of this study is to investigate the importance of leavy vegetable preloading on the postprandial glycaemic and insulinemic response in human subjects when consumed a specific amount of digestible carbohydrate from Russet Burbank potatoes source.
Read the detailed description
The proposed research is part of strategies to manipulate postprandial glycemia and generate weight-control-related benefits, such as promoting satiation. Literature has shown pre-loading caloric nutrients can change postprandial glycemia, but the mechanism is unclear. The investigators hypothesize that a small number of nutrients released in the small intestine can initiate physiological changes and develop feedback control to delay gastric emptying, leading to the delay in digestion of glycemic carbohydrates and the consequent moderate glycemic responses. The investigators propose to use potatoes as the testing glycemic carbohydrates, and the pre-load foods are green vegetables. The investigators will be testing the optimal preload time to achieve the highest control of glycemic response as well as the strongest effect in satiety induction. In addition, green vegetables will be consumed with or without a preload fat enhancer (canola oil) to investigate the mechanism behind significant preload compositions. Healthy adults will be instructed to eat the leafy vegetables first (with or without canola oil), followed by the potato foods (i.e., mashed potatoes). The measurement is the gastric emptying time, blood sugar concentration, insulin, and an appetite-related gut hormone GLP-1. In order to monitor gastric emptying using a non-invasive approach, a popular breath test used in children and a hydrogen breath test will be used to present the change of gastric emptying and the level of gut fermentation.
Results will demonstrate the mechanism of the impact of pre-loading nutrients on the digestion of glycemic carbohydrates. The goal is to eliminate the negative influence of glycemic carbohydrate consumption. Instead, to generate health benefits from dietary carbohydrates.
- Conditions
- Postprandial Hyperglycemia, Insulin High
- Being tested
- Co-ingestion, 0 min preload, 5 min preload, 10 min preload, 15 min preload
- Medical subject headings
- Hyperglycemia, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-ingestionOther
Subjects co-ingest both (300 g mashed potatoes) and (200 g baby round spinach supplemented with canola oil) in the same time.
0 min preloadOther
Subjects consume 200 g baby round spinach supplemented with canola oil first, then directly consume 300 g of mashed potatoes.
5 min preloadOther
Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 5 minutes, then consume 300 g of mashed potatoes.
10 min preloadOther
Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.
15 min preloadOther
Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 15 minutes, then consume 300 g of mashed potatoes.
20 min preloadOther
Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 20 minutes, then consume 300 g of mashed potatoes.
Spinach only / 10 min preloadOther
Subjects consume 200 g baby round spinach WITHOUT canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.
Canola oil only / 10 min preloadOther
Subjects consume 20 g of canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.
| Study group | Role | What they receive |
|---|---|---|
| Control (All 24 participants) | No intervention | Subjects consume 300 g of Russet Burbank mashed Potatoes |
| Co-ingestion (All 24 participants) | Experimental | Subjects co-ingest both (300 g mashed potatoes) and (200 g baby round spinach supplemented with canola oil) in the same time. Receives: Other: Co-ingestion |
| 0 min preload (meal sequence) (10 participants) | Experimental | Subjects consume 200 g baby round spinach supplemented with canola oil first, then directly consume 300 g of mashed potatoes. Receives: Other: 0 min preload |
| 5 min preload (10 participants) | Experimental | Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 5 minutes, then consume 300 g of mashed potatoes. Receives: Other: 5 min preload |
| 10 min preload (10 participants) | Experimental | Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. Receives: Other: 10 min preload |
| 15 min preload (10 participants) | Experimental | Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 15 minutes, then consume 300 g of mashed potatoes. Receives: Other: 15 min preload |
| 20 min preload (10 participants) | Experimental | Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 20 minutes, then consume 300 g of mashed potatoes. Receives: Other: 20 min preload |
| Spinach only /10 min preload (All 24 participants) | Experimental | Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. Receives: Other: Spinach only / 10 min preload |
| (Spinach + Canola oil) 10 min preload (All 24 participants) | Experimental | Subjects consume 200 g baby round spinach WITHOUT canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. Receives: Other: 10 min preload |
| Canola oil only / 10 min preload (All 24 participants) | Experimental | Subjects consume 20 g of canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. Receives: Other: Canola oil only / 10 min preload |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose
Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Glucose levels are tested in the serum using cobas c311 analyzer.
Measured: up to 3 hour (180 minutes) after test meal consumption
Postprandial blood Insulin
Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Insulin levels are tested in the serum using cobas e411 Immunoanalyzer.
Measured: up to 3 hour (180 minutes) after test meal consumption
Postprandial Glucagon Like Peptide -1 Total (GLP-1)
Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. GLP-1 levels are tested in the plasma using GLP-1 Total ELISA kit (EZGLP1T-36K)
Measured: up to 3 hour (180 minutes) after test meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Sep 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion19 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- Alliance for Potato Research and Education
- Responsible party
- Principal investigator, Amy Lin, PhD, Singapore Institute of Food and Biotechnology Innovation
- Investigators
- Amy Lin, PhD, Principal investigator, Senior Principal Scientist I at Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640335
- Sponsor's protocol ID
- 2021-095
- Acronym
- APRE
- Status last verified
- Nov 2024
- First submitted
- 10 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the approved IRB# 2021-095, all IPD are owned by Singapore Institute of Food and Biotechnology Innovation (SIFBI)
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vegetable Preloading on Postprandial Glycemia, Insulinaemia and Gastric Emptying in Healthy Adults: A Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT06640335
- Acronym / sponsor ID
- APRE / 2021-095
- Conditions
- Postprandial Hyperglycemia, Insulin High
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- Alliance for Potato Research and Education
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 19 Sep 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
The objective of this study is to investigate the importance of leavy vegetable preloading on the postprandial glycaemic and insulinemic response in human subjects when consumed a specific amount of digestible carbohydrate from Russet Burbank potatoes source.
Detailed description
The proposed research is part of strategies to manipulate postprandial glycemia and generate weight-control-related benefits, such as promoting satiation. Literature has shown pre-loading caloric nutrients can change postprandial glycemia, but the mechanism is unclear. The investigators hypothesize that a small number of nutrients released in the small intestine can initiate physiological changes and develop feedback control to delay gastric emptying, leading to the delay in digestion of glycemic carbohydrates and the consequent moderate glycemic responses. The investigators propose to use potatoes as the testing glycemic carbohydrates, and the pre-load foods are green vegetables. The investigators will be testing the optimal preload time to achieve the highest control of glycemic response as well as the strongest effect in satiety induction. In addition, green vegetables will be consumed with or without a preload fat enhancer (canola oil) to investigate the mechanism behind significant preload compositions. Healthy adults will be instructed to eat the leafy vegetables first (with or without canola oil), followed by the potato foods (i.e., mashed potatoes). The measurement is the gastric emptying time, blood sugar concentration, insulin, and an appetite-related gut hormone GLP-1. In order to monitor gastric emptying using a non-invasive approach, a popular breath test used in children and a hydrogen breath test will be used to present the change of gastric emptying and the level of gut fermentation.
Results will demonstrate the mechanism of the impact of pre-loading nutrients on the digestion of glycemic carbohydrates. The goal is to eliminate the negative influence of glycemic carbohydrate consumption. Instead, to generate health benefits from dietary carbohydrates.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Control (All 24 participants) | No intervention | –Subjects consume 300 g of Russet Burbank mashed Potatoes |
| Co-ingestion (All 24 participants) | Experimental | Other: Co-ingestionSubjects co-ingest both (300 g mashed potatoes) and (200 g baby round spinach supplemented with canola oil) in the same time. |
| 0 min preload (meal sequence) (10 participants) | Experimental | Other: 0 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, then directly consume 300 g of mashed potatoes. |
| 5 min preload (10 participants) | Experimental | Other: 5 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, wait 5 minutes, then consume 300 g of mashed potatoes. |
| 10 min preload (10 participants) | Experimental | Other: 10 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. |
| 15 min preload (10 participants) | Experimental | Other: 15 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, wait 15 minutes, then consume 300 g of mashed potatoes. |
| 20 min preload (10 participants) | Experimental | Other: 20 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, wait 20 minutes, then consume 300 g of mashed potatoes. |
| Spinach only /10 min preload (All 24 participants) | Experimental | Other: Spinach only / 10 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. |
| (Spinach + Canola oil) 10 min preload (All 24 participants) | Experimental | Other: 10 min preloadSubjects consume 200 g baby round spinach WITHOUT canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. |
| Canola oil only / 10 min preload (All 24 participants) | Experimental | Other: Canola oil only / 10 min preloadSubjects consume 20 g of canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Normal body mass index (18.5 kg/m2 to 24.9 kg/m2), weight >/= 45 kg
- Normal blood pressure </=120/80 mmH
- Fasting blood glucose of <5.6 mmol/l
- Able to provide written informed consent before participating in the study.
- Able to communicate adequately to comply with the requirements of the entire study, i.e., able to eat test meal and provide breath samples.
Key exclusion criteria (15 listed)
- Smokers.
- Individuals with any metabolic diseases (such as diabetes, hypertension etc).
- Individuals with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency).
- Individuals with medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics).
- Individuals who take any prescribed medication or dietary supplements which may interfere with the study measurements.
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 |
|---|---|---|
| Co-ingestionSubjects co-ingest both (300 g mashed potatoes) and (200 g baby round spinach supplemented with canola oil) in the same time. | Other | Co-ingestion (All 24 participants) |
| 0 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, then directly consume 300 g of mashed potatoes. | Other | 0 min preload (meal sequence) (10 participants) |
| 5 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, wait 5 minutes, then consume 300 g of mashed potatoes. | Other | 5 min preload (10 participants) |
| 10 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. | Other | (Spinach + Canola oil) 10 min preload (All 24 participants), 10 min preload (10 participants) |
| 15 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, wait 15 minutes, then consume 300 g of mashed potatoes. | Other | 15 min preload (10 participants) |
| 20 min preloadSubjects consume 200 g baby round spinach supplemented with canola oil first, wait 20 minutes, then consume 300 g of mashed potatoes. | Other | 20 min preload (10 participants) |
| Spinach only / 10 min preloadSubjects consume 200 g baby round spinach WITHOUT canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. | Other | Spinach only /10 min preload (All 24 participants) |
| Canola oil only / 10 min preloadSubjects consume 20 g of canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes. | Other | Canola oil only / 10 min preload (All 24 participants) |
Primary outcome
Postprandial blood glucose
Time frame: up to 3 hour (180 minutes) after test meal consumption
Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Glucose levels are tested in the serum using cobas c311 analyzer.
Postprandial blood Insulin
Time frame: up to 3 hour (180 minutes) after test meal consumption
Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Insulin levels are tested in the serum using cobas e411 Immunoanalyzer.
Postprandial Glucagon Like Peptide -1 Total (GLP-1)
Time frame: up to 3 hour (180 minutes) after test meal consumption
Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. GLP-1 levels are tested in the plasma using GLP-1 Total ELISA kit (EZGLP1T-36K)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No. According to the approved IRB# 2021-095, all IPD are owned by Singapore Institute of Food and Biotechnology Innovation (SIFBI)
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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.
Amy Lin, PhD principal investigator
Senior Principal Scientist I at Singapore Institute of Food and Biotechnology Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-ingestion, 0 min preload and 5 min preload in people with Postprandial Hyperglycemia and Insulin High, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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 5 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2024. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
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 blood glucose (time frame: up to 3 hour (180 minutes) after test meal consumption). 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?
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 8 Nov 2024.