Dietary SupplementLORIS-02NCT05963594
To Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With T2D and in HAO
A study testing Oligomalt and maltodextrin in people with Dietary Supplement, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
The goal of this mechanistic, exploratory study is to compare the effectiveness of Oligomalt to Glucidex 40 after eating in adults with Type 2 Diabetes (T2D) and in otherwise healthy adults with overweight or obesity (HAO). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplement
- What is being tested?
- Oligomalt and maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to 28 Mar 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to sign written informed consent prior to study entry.
- Male or female, >18 years of age.
- Established diagnosis of T2D (documented by either HbA1c 6.5 - 10.0% or a history of T2D diagnosis).
- Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
- Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
- Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.
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- Willing and able to sign written informed consent prior to study entry.
- Male or female, >18 years of age.
- BMI ≥ 25 kg/m2.
- Fasting plasma glucose (FPG) ≤ 125 mg/dL.
Who cannot join
- Type 1 diabetes.
- Known food allergy or intolerance to study products.
- Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments.
- Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily.
- Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures 4 weeks prior to dosing.
- Current use of injectable insulin therapy, any other oral (other than metformin) or injectable glucose-lowering drug. Current use of weight loss interventions or treatment with anorectic drugs (e.g., GLP-1 receptor analogues).
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- Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors).
- Current treatment with systemic steroids (application of inhaled or topical steroids is permitted).
- Recent episode of an acute gastrointestinal illness.
- Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer.
- Current daily cigarette smoking.
- Are unable to comply with protocol procedures in the opinion of the investigator.
- Have a hierarchical link with the research team members.
- Positive pregnancy test or breast-feeding at screening.
- Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
- Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.
- HAO:
- Otherwise Healthy Adults (HAO) with overweight or obese but who DO NOT present with a confirmed diagnosis of diabetes mellitus
- Type 1 or type 2 diabetes (including those potentially detected at screening).
- 2-h plasma glucose ≥ 200 mg/dL - if measured within 6 weeks prior to screening.
- Known food allergy or intolerance to study products.
- Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments.
- Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily.
- Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior to dosing.
- Current use of injectable insulin therapy, any oral or injectable glucose-lowering drug.
- Current use of weight loss interventions or treatment with anorectic drugs (e.g., GLP-1 receptor analogues).
- Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors).
- Current treatment with systemic steroids (application of inhaled or topical steroids is permitted).
- Recent episode of an acute gastrointestinal illness.
- Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer.
- Current daily cigarette smoking.
- Are unable to comply with protocol procedures in the opinion of the investigator.
- Positive pregnancy test or breast-feeding at screening.
- Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
- Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Randomized, Double-Blind, Comparator-Controlled, Crossover Study to Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With Type 2 Diabetes (T2D) and in Otherwise Healthy Adults With Overweight or Obesity (HAO)
The goal of this mechanistic, exploratory study is to compare the effectiveness of Oligomalt to Glucidex 40 after eating in adults with Type 2 Diabetes (T2D) and in otherwise healthy adults with overweight or obesity (HAO).
Read the detailed description
The main question it aims to answer is how consumption of Oligomalt, a slowly digestible carbohydrate, will reduce glucose and insulin spikes in adults with T2D and in HAO relative to Glucidex 40.
- Conditions
- Dietary Supplement
- Being tested
- Oligomalt, maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OligomaltDietary supplement
The investigational product (Oligomalt) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours.
maltodextrinDietary supplement
Also called Glucidex 40
The investigational product (maltodextrin) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| T2D Sequence AB | Active comparator | Where A = 50 g Oligomalt and B = 50 g Glucidex 40. Receives: Dietary Supplement: Oligomalt; Dietary Supplement: maltodextrin |
| T2D Sequence BA | Active comparator | Where A = 50 g Oligomalt and B = 50 g Glucidex 40. Receives: Dietary Supplement: Oligomalt; Dietary Supplement: maltodextrin |
| HAO Sequence ABCD | Active comparator | Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. Receives: Dietary Supplement: Oligomalt; Dietary Supplement: maltodextrin |
| HAO Sequence BDAC | Active comparator | Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. Receives: Dietary Supplement: Oligomalt; Dietary Supplement: maltodextrin |
| HAO Sequence DCBA | Active comparator | Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. Receives: Dietary Supplement: Oligomalt; Dietary Supplement: maltodextrin |
| HAO Sequence CADB | Active comparator | Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. Receives: Dietary Supplement: Oligomalt; Dietary Supplement: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the curve (iAUC) of post-prandial glycemic excursion induced by Oligomalt relative to maltodextrin over the observation period: iAUC 0-1 hour, iAUC 0-2 hours, iAUC 0-3 hours.
Comparisons in the T2D group: 50 g Oligomalt vs 50 g Glucidex 40. Comparisons in the HAO group: 33 g Oligomalt vs 33 g Glucidex 40 and 50 g Oligomalt vs 50 g Glucidex 40.
Measured: Over the course of 3 hours following study product intake
Secondary outcomes (13)
Total blood glucose AUC
Measured: Over the course of 3 hours following study product intake
Blood glucose (iCmax)
Maximum blood glucose level
Measured: Over the course of 3 hours following study product intake
Blood glucose (Cmin)
Minimum blood glucose level
Measured: Over the course of 3 hours following study product intake
Blood glucose (Tmax)
Time point at which maximum blood glucose level is measured
Measured: Over the course of 3 hours following study product intake
Blood glucose (Tmin)
Time point at which minimum blood glucose level is measured
Measured: Over the course of 3 hours following study product intake
Number of participants with glucose levels less than or equal to 3.9 mmol/L
Measured: Over the course of 3 hours following study product intake
Number of participants with glucose levels less than or equal to 3.1 mmol/L
Measured: Over the course of 3 hours following study product intake
Serum insulin level
Measured: Over the course of 3 hours following study product intake
Insulinogenic index (IGI)
A measure of early β-cell capacity (first- phase insulin response)
Measured: 30 minutes
Insulin index
Measured: Over the course of 2 hours following study product intake
Matsuda Index (MI)
Measured: Over the course of 2 hours following study product intake
Plasma glucagon-like peptide 1 (GLP-1)
Measured: Over the course of up to 3 hours following study product intake
Plasma peptide tyrosine (PYY)
Measured: Over the course of up to 3 hours following study product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start23 Jan 2023
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Neutel, MD, Principal investigator, Orange County Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963594
- Sponsor's protocol ID
- 22.06.CLI
- Acronym
- LORIS-02
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Comparator-Controlled, Crossover Study to Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With Type 2 Diabetes (T2D) and in Otherwise Healthy Adults With Overweight or Obesity (HAO)
- ClinicalTrials.gov ID
- NCT05963594
- Acronym / sponsor ID
- LORIS-02 / 22.06.CLI
- Conditions
- Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 27 Jul 2023 (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 goal of this mechanistic, exploratory study is to compare the effectiveness of Oligomalt to Glucidex 40 after eating in adults with Type 2 Diabetes (T2D) and in otherwise healthy adults with overweight or obesity (HAO).
Detailed description
The main question it aims to answer is how consumption of Oligomalt, a slowly digestible carbohydrate, will reduce glucose and insulin spikes in adults with T2D and in HAO relative to Glucidex 40.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| T2D Sequence AB | Active comparator | Dietary Supplement: Oligomalt, Dietary Supplement: maltodextrinWhere A = 50 g Oligomalt and B = 50 g Glucidex 40. |
| T2D Sequence BA | Active comparator | Dietary Supplement: Oligomalt, Dietary Supplement: maltodextrinWhere A = 50 g Oligomalt and B = 50 g Glucidex 40. |
| HAO Sequence ABCD | Active comparator | Dietary Supplement: Oligomalt, Dietary Supplement: maltodextrinWhere A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. |
| HAO Sequence BDAC | Active comparator | Dietary Supplement: Oligomalt, Dietary Supplement: maltodextrinWhere A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. |
| HAO Sequence DCBA | Active comparator | Dietary Supplement: Oligomalt, Dietary Supplement: maltodextrinWhere A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. |
| HAO Sequence CADB | Active comparator | Dietary Supplement: Oligomalt, Dietary Supplement: maltodextrinWhere A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to sign written informed consent prior to study entry.
- Male or female, >18 years of age.
- Established diagnosis of T2D (documented by either HbA1c 6.5 - 10.0% or a history of T2D diagnosis).
- Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
- Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
Key exclusion criteria (35 listed)
- Type 1 diabetes.
- Known food allergy or intolerance to study products.
- Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments.
- Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily.
- Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures 4 weeks prior to dosing.
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 |
|---|---|---|
| OligomaltThe investigational product (Oligomalt) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours. | Dietary supplement | HAO Sequence ABCD, HAO Sequence BDAC, HAO Sequence CADB, HAO Sequence DCBA, T2D Sequence AB, T2D Sequence BA |
| maltodextrinAlso: Glucidex 40The investigational product (maltodextrin) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours. | Dietary supplement | HAO Sequence ABCD, HAO Sequence BDAC, HAO Sequence CADB, HAO Sequence DCBA, T2D Sequence AB, T2D Sequence BA |
Primary outcome
Incremental area under the curve (iAUC) of post-prandial glycemic excursion induced by Oligomalt relative to maltodextrin over the observation period: iAUC 0-1 hour, iAUC 0-2 hours, iAUC 0-3 hours.
Time frame: Over the course of 3 hours following study product intake
Comparisons in the T2D group: 50 g Oligomalt vs 50 g Glucidex 40. Comparisons in the HAO group: 33 g Oligomalt vs 33 g Glucidex 40 and 50 g Oligomalt vs 50 g Glucidex 40.
13 secondary outcomes
Total blood glucose AUC
Time frame: Over the course of 3 hours following study product intake
Blood glucose (iCmax)
Time frame: Over the course of 3 hours following study product intake
Blood glucose (Cmin)
Time frame: Over the course of 3 hours following study product intake
Blood glucose (Tmax)
Time frame: Over the course of 3 hours following study product intake
Blood glucose (Tmin)
Time frame: Over the course of 3 hours following study product intake
Number of participants with glucose levels less than or equal to 3.9 mmol/L
Time frame: Over the course of 3 hours following study product intake
Number of participants with glucose levels less than or equal to 3.1 mmol/L
Time frame: Over the course of 3 hours following study product intake
Serum insulin level
Time frame: Over the course of 3 hours following study product intake
Insulinogenic index (IGI)
Time frame: 30 minutes
Insulin index
Time frame: Over the course of 2 hours following study product intake
Matsuda Index (MI)
Time frame: Over the course of 2 hours following study product intake
Plasma glucagon-like peptide 1 (GLP-1)
Time frame: Over the course of up to 3 hours following study product intake
Plasma peptide tyrosine (PYY)
Time frame: Over the course of up to 3 hours following study product intake
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 27 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Joel Neutel, MD principal investigator
Orange County Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligomalt and maltodextrin in people with Dietary Supplement, run by Société des Produits Nestlé (SPN) at 1 site in United States.
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 10 inclusion and 35 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 27 Jul 2023. 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 United States. 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?
Incremental area under the curve (iAUC) of post-prandial glycemic excursion induced by Oligomalt relative to maltodextrin over the observation period: iAUC 0-1 hour, iAUC 0-2 hours, iAUC 0-3 hours. (time frame: Over the course of 3 hours following study product intake). 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 27 Jul 2023.