Diabetes Mellitus, Type 2NCT03806920
Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and Second Meal Effect
A study testing Intervention A, Intervention B and Intervention C in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
This study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as an determinant for the second meal effect. In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metabolic Syndrome
- What is being tested?
- Intervention A, Intervention B and Intervention C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 5 Nov 2016to 30 Jul 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- for T2DM patients: insulin-independent
- for healthy subjects: at least 1 component of the metabolic syndrom:
- Body mass index (BMI) ≥ 30 kg/m²
- Waist-hip ratio (WHR) ≥ 85 for women and ≥ 90 for men
- hypertension
- dyslipidemia
- glucose / insulin intolerance
Who cannot join
- medications: intake of medications which influence glucose metabolism
- alcohol / drug abuse
- physical diseases: endocrinological, malign, serious cardiovascular diseases
- acute / chronic communicable disease
- psychic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isomaltulose VS Sucrose - Different Postprandial Effect on Incretin Profile and Determinants of the Second Meal Effect
This study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as an determinant for the second meal effect.
In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separate days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.
Read the detailed description
Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2. Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a stimulated secretion of GLP-1. In addition, several studies have shown that the intake of foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction to a subsequent meal. As the exact mechanism of this "second meal effect" is still unknown, the investigators hypothesize that the modified release and action of GIP and GLP-1 are key players in regard to the described effects.Therefore, isomaltulose could be a suitable tool for reducing the risk of developing diabetes, obesity and CVD as well as improve blood glucose control in people with diabetes.
In summary, this study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as a determinant for the second meal effect.
In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separated days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Syndrome
- Being tested
- Intervention A, Intervention B, Intervention C, Intervention D
- Keywords
- Isomaltulose, Palatinose, second meal effect, incretin, GIP, GLP-1, postprandial inflammation
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ADietary supplement
Intervention BDietary supplement
Intervention CDietary supplement
Intervention DDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Intervention A | Active comparator | Nutritional intervention in healthy subjects and T2DM subjects:
Accompanying a carbohydrate based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours. Receives: Dietary Supplement: Intervention A |
| Intervention B | Active comparator | Nutritional intervention in healthy subjects and T2DM subjects:
Accompanying a carbohydrate based breakfast, participants ingest either 50 g palatinose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours. Receives: Dietary Supplement: Intervention B |
| Intervention C | Active comparator | Nutritional intervention in healthy subjects:
Accompanying a protein-based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours. Receives: Dietary Supplement: Intervention C |
| Intervention D | Active comparator | Nutritional intervention in healthy subjects:
Accompanying a protein-based breakfast, participants ingest either 50 g isomaltulose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours. Receives: Dietary Supplement: Intervention D |
What is being measured
The primary outcome is the main question the study is designed to answer.
disposition index
Alteration of the Insulin secretion due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved beta-cell response (Insulin secretion)
Measured: 4 visits, separated by 1 week each
insulinogenic index
Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved second meal effect (Insulin sensitivity).
Measured: 4 visits, separated by 1 week each
hepatic insulin extraction
Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved hepatic insulin extraction (secondary effect of improved Insulin sensitivity).
Measured: 4 visits, separated by 1 week each
Secondary outcomes (4)
incretin response
Parameters: GIP, GLP-1, gastric emptying, Glucagon
Measured: 4 visits, separated by 1 week each
inflammatory reaction
Parameters: IL8, IL-18
Measured: 4 visits, separated by 1 week each
Lipid status
Parameters: NEFA
Measured: 4 visits, separated by 1 week each
additional endocrine parameters
Parameters: FGF21
Measured: 4 visits, separated by 1 week each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start5 Nov 2016
- Primary completion30 Sep 2018
- Study completion30 Jul 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 Diabetes Mellitus, Type 2Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Comparison of sucrose vs. palatinose (isomaltulose) on second meal effect (high-GI meal vs. high-protein meal) in subjects with T2DM or metabolic Syndrome without T2DM
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Beneo GmbH
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806920
- Sponsor's protocol ID
- PALA
- Status last verified
- Jun 2020
- First submitted
- 8 Nov 2017
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Schafer SM, Kabisch S, Csanalosi M, Schuppelius B, Kemper M, Markova M, Meyer NMT, Pivovarova-Ramich O, Keyhani-Nejad F, Rohn S, Pfeiffer AFH. Implication of sugar, protein and incretins in excessive glucagon secretion in type 2 diabetes after mixed meals. Clin Nutr. 2023 Apr;42(4):467-476. doi: 10.1016/j.clnu.2023.02.011. Epub 2023 Feb 21.
PubMed 36857956
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isomaltulose VS Sucrose - Different Postprandial Effect on Incretin Profile and Determinants of the Second Meal Effect
- ClinicalTrials.gov ID
- NCT03806920
- Acronym / sponsor ID
- PALA
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Syndrome
- Keywords
- Isomaltulose, Palatinose, second meal effect, incretin, GIP, GLP-1, postprandial inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- Beneo GmbH
- Study start
- 5 Nov 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 16 Jan 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.
This study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as an determinant for the second meal effect.
In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separate days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.
Detailed description
Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2. Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a stimulated secretion of GLP-1. In addition, several studies have shown that the intake of foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction to a subsequent meal. As the exact mechanism of this "second meal effect" is still unknown, the investigators hypothesize that the modified release and action of GIP and GLP-1 are key players in regard to the described effects.Therefore, isomaltulose could be a suitable tool for reducing the risk of developing diabetes, obesity and CVD as well as improve blood glucose control in people with diabetes.
In summary, this study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as a determinant for the second meal effect.
In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separated days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Comparison of sucrose vs. palatinose (isomaltulose) on second meal effect (high-GI meal vs. high-protein meal) in subjects with T2DM or metabolic Syndrome without T2DM
| Arm | Type | Receives |
|---|---|---|
| Intervention A | Active comparator | Dietary Supplement: Intervention ANutritional intervention in healthy subjects and T2DM subjects: Accompanying a carbohydrate based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours. |
| Intervention B | Active comparator | Dietary Supplement: Intervention BNutritional intervention in healthy subjects and T2DM subjects: Accompanying a carbohydrate based breakfast, participants ingest either 50 g palatinose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours. |
| Intervention C | Active comparator | Dietary Supplement: Intervention CNutritional intervention in healthy subjects: Accompanying a protein-based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours. |
| Intervention D | Active comparator | Dietary Supplement: Intervention DNutritional intervention in healthy subjects: Accompanying a protein-based breakfast, participants ingest either 50 g isomaltulose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- for T2DM patients: insulin-independent
- for healthy subjects: at least 1 component of the metabolic syndrom:
Key exclusion criteria (5 listed)
- medications: intake of medications which influence glucose metabolism
- alcohol / drug abuse
- physical diseases: endocrinological, malign, serious cardiovascular diseases
- acute / chronic communicable disease
- psychic diseases
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 |
|---|---|---|
| Intervention A | Dietary supplement | Intervention A |
| Intervention B | Dietary supplement | Intervention B |
| Intervention C | Dietary supplement | Intervention C |
| Intervention D | Dietary supplement | Intervention D |
Primary outcome
disposition index
Time frame: 4 visits, separated by 1 week each
Alteration of the Insulin secretion due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved beta-cell response (Insulin secretion)
insulinogenic index
Time frame: 4 visits, separated by 1 week each
Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved second meal effect (Insulin sensitivity).
hepatic insulin extraction
Time frame: 4 visits, separated by 1 week each
Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved hepatic insulin extraction (secondary effect of improved Insulin sensitivity).
4 secondary outcomes
incretin response
Time frame: 4 visits, separated by 1 week each
inflammatory reaction
Time frame: 4 visits, separated by 1 week each
Lipid status
Time frame: 4 visits, separated by 1 week each
additional endocrine parameters
Time frame: 4 visits, separated by 1 week each
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 24 Jun 2020.
- Derived from this study: PubMed 36857956Zhang J, Schafer SM, Kabisch S, Csanalosi M, Schuppelius B, Kemper M, Markova M, Meyer NMT, Pivovarova-Ramich O, Keyhani-Nejad F, Rohn S, Pfeiffer AFH. Implication of sugar, protein and incretins in excessive glucagon secretion in type 2 diabetes after mixed meals. Clin Nutr. 2023 Apr;42(4):467-476. doi: 10.1016/j.clnu.2023.02.011. Epub 2023 Feb 21.
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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.
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 Intervention A, Intervention B and Intervention C in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by German Institute of Human Nutrition at 1 site in Germany.
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 7 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 24 Jun 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 Germany. 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?
disposition index (time frame: 4 visits, separated by 1 week each). 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 NCT03806920, 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 24 Jun 2020.