Metabolic SyndromeGLYSIMINCT05120661
Elucidating the Role of Human Small Intestine Microbiota in Explaining Differences in Postprandial Glucose Responses
A study testing food product in people with Metabolic Syndrome and Obesity, run by Wageningen University at 1 site in Netherlands.
Trial summary
It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity, Overweight
- What is being tested?
- food product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Dec 2021to 1 Jul 2022
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females
- BMI≥25 kg/m2
- Age 40-75 years
- Signed informed consent
Who cannot join
- Having a history of medical or surgical events that may either put the subject at risk because of participation in the study, or influence the results of the study, including diabetes type 1, a swallowing disorder, gastrointestinal or liver disease, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants;
- Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
- Use of antibiotics within 2 months of starting the study or planned during the study;
- Use of medication that could influence the study results, such as diabetes treatment;
- Use of pro- and prebiotic supplements;
- Sensitive to medical skin adhesives;
Show all 15Show fewer
- Having an allergy or intolerance towards compounds in the test products;
- Follows a vegan diet;
- Excessive alcohol consumption (on average >21 glasses/week for men and >14 glasses/week for women);
- Currently a research subject in another clinical trial;
- Having blood vessels that are too difficult for inserting a cannula/blood drawing'
- Having a hemoglobin level <8.5 mmol/l (men) or <7.5 mmol/l (women);
- Being a blood donor during the duration of the study;
- Not having a General Practitioner (GP);
- Being an employee of Wageningen University, division Human Nutrition and Health.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elucidating the Role of Human Small Intestine Microbiota in Interpersonal Differences in GLYcemic Responses Upon Consumption of Food Products: A Proof of Principle Study
It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. The role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products will be investigated. First a screening will take place with to choose the test products that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. The study will be a 6-day randomized cross-over trial with two test days. Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test will be provided to participants. Twenty men or women (BMI≥25 kg/m2, 40-75 years old) will be included. The main study parameters/endpoints are the food product-induced plasma glucose responses (iAUC) and the small intestine microbiota.
Read the detailed description
Rationale: It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. Differences in small intestine microbiota are hypothesized to be key in explaining the interpersonal differences in glycemic responses.
Objective: To investigate the role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products.
Study design: The subjects will wear a continuous glucose monitor during the screening and the study. First a screening (14 days in total) will take place with to choose the test products (2 out of 4) that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. Also an OGTT will be performed. The study will be a randomized cross-over trial with two test days (length of trial is 6 days in total). During the trial, the subjects will be intubated with a naso-jejunum catheter.
Study population: Twenty men or women (BMI≥25 kg/m2, 40-75 years old). Intervention (if applicable): Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test.
Main study parameters/endpoints: test (food) product-induced plasma glucose responses (iAUC), small intestine microbiota.
- Conditions
- Metabolic Syndrome, Obesity, Overweight, Microbiota, Small Intestine, Digestion
- Being tested
- food product
- Medical subject headings
- Metabolic Syndrome, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food productOther
a food product containing 50 gram carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate-rich food product (to be determined) | Experimental | This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates. Receives: Other: food product |
| Another carbohydrate-rich food product (to be determined) | Experimental | This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates. Receives: Other: food product |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial glucose response (iAUC) per test product
iAUC glucose
Measured: 0-120 minutes
small intestine microbiome
the relative composition (%) and the functional capacity (%) of the small intestine microbiota
Measured: at baseline
Secondary outcomes (17)
macronutrients in the small intestinal aspirates
amounts of carbohydrates, proteins, fats
Measured: 0-240 minutes
presence and production of (bacterial) degradation products in the small intestinal aspirates
concentrations of organic acids and short-chain fatty acids
Measured: 0-240 minutes
digestive enzymes in the small intestinal aspirates
concentrations of amylase
Measured: 0-240 minutes
non-absorbable marker in the small intestinal aspirates
peg-4000 concentrations
Measured: 0-240 minutes
blood HbA1c
concentrations of HbA1c
Measured: 0-240 minutes
blood glucose
concentrations glucose (e.g. GLP-1, PYY)
Measured: 0-240 minutes
blood insulin
concentrations of insulin
Measured: 0-240 minutes
blood glucagon
concentrations of glucagon
Measured: 0-240 minutes
blood total triglycerides
concentrations of triglycerides
Measured: 0-240 minutes
blood total free fatty acids
concentrations of free fatty acids
Measured: 0-240 minutes
plasma gut hormones
concentrations of gut hormones (e.g. GLP-1, PYY)
Measured: 0-240 minutes
breath 13C-lactosyl ureide
concentrations of 13C-lactosyl ureide
Measured: 0-240 minutes
breath hydrogen
concentrations of hydrogen (ppm)
Measured: 0-240 minutes
breath methane
concentrations of methane (ppm)
Measured: 0-240 minutes
Oral microbiome composition
microbiota relative composition (%)
Measured: baseline
Salivary α-amylase
concentrations of a-amylase
Measured: 0-240 minutes
Fecal microbiota composition
microbiota relative composition (%)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start9 Dec 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Hooiveld, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120661
- Sponsor's protocol ID
- NL78737.091.21
- Acronym
- GLYSIMI
- Status last verified
- Mar 2024
- First submitted
- 11 Oct 2021
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Role of Human Small Intestine Microbiota in Interpersonal Differences in GLYcemic Responses Upon Consumption of Food Products: A Proof of Principle Study
- ClinicalTrials.gov ID
- NCT05120661
- Acronym / sponsor ID
- GLYSIMI / NL78737.091.21
- Conditions
- Metabolic Syndrome, Obesity, Overweight, Microbiota, Small Intestine, Digestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 15 Nov 2021 (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.
It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. The role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products will be investigated. First a screening will take place with to choose the test products that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. The study will be a 6-day randomized cross-over trial with two test days. Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test will be provided to participants. Twenty men or women (BMI≥25 kg/m2, 40-75 years old) will be included. The main study parameters/endpoints are the food product-induced plasma glucose responses (iAUC) and the small intestine microbiota.
Detailed description
Rationale: It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. Differences in small intestine microbiota are hypothesized to be key in explaining the interpersonal differences in glycemic responses.
Objective: To investigate the role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products.
Study design: The subjects will wear a continuous glucose monitor during the screening and the study. First a screening (14 days in total) will take place with to choose the test products (2 out of 4) that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. Also an OGTT will be performed. The study will be a randomized cross-over trial with two test days (length of trial is 6 days in total). During the trial, the subjects will be intubated with a naso-jejunum catheter.
Study population: Twenty men or women (BMI≥25 kg/m2, 40-75 years old). Intervention (if applicable): Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test.
Main study parameters/endpoints: test (food) product-induced plasma glucose responses (iAUC), small intestine microbiota.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate-rich food product (to be determined) | Experimental | Other: food productThis is a nutritional product, such as bread or cake, containing 50 gram carbohydrates. |
| Another carbohydrate-rich food product (to be determined) | Experimental | Other: food productThis is a nutritional product, such as bread or cake, containing 50 gram carbohydrates. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females
- BMI≥25 kg/m2
- Age 40-75 years
- Signed informed consent
Key exclusion criteria (15 listed)
- Having a history of medical or surgical events that may either put the subject at risk because of participation in the study, or influence the results of the study, including diabetes type 1, a swallowing disorder, gastrointestinal or liver disease, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants;
- Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
- Use of antibiotics within 2 months of starting the study or planned during the study;
- Use of medication that could influence the study results, such as diabetes treatment;
- Use of pro- and prebiotic supplements;
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 |
|---|---|---|
| food producta food product containing 50 gram carbohydrates | Other | Another carbohydrate-rich food product (to be determined), Carbohydrate-rich food product (to be determined) |
Primary outcome
postprandial glucose response (iAUC) per test product
Time frame: 0-120 minutes
iAUC glucose
small intestine microbiome
Time frame: at baseline
the relative composition (%) and the functional capacity (%) of the small intestine microbiota
17 secondary outcomes
macronutrients in the small intestinal aspirates
Time frame: 0-240 minutes
presence and production of (bacterial) degradation products in the small intestinal aspirates
Time frame: 0-240 minutes
digestive enzymes in the small intestinal aspirates
Time frame: 0-240 minutes
non-absorbable marker in the small intestinal aspirates
Time frame: 0-240 minutes
blood HbA1c
Time frame: 0-240 minutes
blood glucose
Time frame: 0-240 minutes
blood insulin
Time frame: 0-240 minutes
blood glucagon
Time frame: 0-240 minutes
blood total triglycerides
Time frame: 0-240 minutes
blood total free fatty acids
Time frame: 0-240 minutes
plasma gut hormones
Time frame: 0-240 minutes
breath 13C-lactosyl ureide
Time frame: 0-240 minutes
breath hydrogen
Time frame: 0-240 minutes
breath methane
Time frame: 0-240 minutes
Oral microbiome composition
Time frame: baseline
Salivary α-amylase
Time frame: 0-240 minutes
Fecal microbiota composition
Time frame: baseline
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 28 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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 food product in people with Metabolic Syndrome and Obesity, run by Wageningen University at 1 site in Netherlands.
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 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: finished, as of the sponsor's last update on 28 Mar 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 Netherlands. 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 response (iAUC) per test product (time frame: 0-120 minutes). The study lists 2 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 28 Mar 2024.