To Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With T2D and in HAO

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Dietary Supplement

Intervention / Treatment
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* Dietary Supplement: Oligomalt
* Dietary Supplement: maltodextrin


Participation Criteria
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Eligibility Criteria
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Type 2 Diabetes (T2D) Inclusion criteria: 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. Exclusion Criteria: 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). 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 Inclusion criteria: 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. Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T2D Sequence AB<br>Where A = 50 g Oligomalt and B = 50 g Glucidex 40. | Dietary Supplement: Oligomalt<br>* 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.<br>Dietary Supplement: maltodextrin<br>* 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.<br>* Other names: Glucidex 40;|
| Active Comparator: T2D Sequence BA<br>Where A = 50 g Oligomalt and B = 50 g Glucidex 40. | Dietary Supplement: Oligomalt<br>* 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.<br>Dietary Supplement: maltodextrin<br>* 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.<br>* Other names: Glucidex 40;|
| Active Comparator: HAO Sequence ABCD<br>Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. | Dietary Supplement: Oligomalt<br>* 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.<br>Dietary Supplement: maltodextrin<br>* 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.<br>* Other names: Glucidex 40;|
| Active Comparator: HAO Sequence BDAC<br>Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. | Dietary Supplement: Oligomalt<br>* 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.<br>Dietary Supplement: maltodextrin<br>* 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.<br>* Other names: Glucidex 40;|
| Active Comparator: HAO Sequence DCBA<br>Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. | Dietary Supplement: Oligomalt<br>* 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.<br>Dietary Supplement: maltodextrin<br>* 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.<br>* Other names: Glucidex 40;|
| Active Comparator: HAO Sequence CADB<br>Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40. | Dietary Supplement: Oligomalt<br>* 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.<br>Dietary Supplement: maltodextrin<br>* 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.<br>* Other names: Glucidex 40;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Over the course of 3 hours following study product intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood glucose AUC |  | Over the course of 3 hours following study product intake | 
| Blood glucose (iCmax) | Maximum blood glucose level | Over the course of 3 hours following study product intake | 
| Blood glucose (Cmin) | Minimum blood glucose level | Over the course of 3 hours following study product intake | 
| Blood glucose (Tmax) | Time point at which maximum blood glucose level is measured | Over the course of 3 hours following study product intake | 
| Blood glucose (Tmin) | Time point at which minimum blood glucose level is 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 |  | 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 |  | Over the course of 3 hours following study product intake | 
| Serum insulin level |  | Over the course of 3 hours following study product intake | 
| Insulinogenic index (IGI) | A measure of early β-cell capacity (first- phase insulin response) | 30 minutes | 
| Insulin index |  | Over the course of 2 hours following study product intake | 
| Matsuda Index (MI) |  | Over the course of 2 hours following study product intake | 
| Plasma glucagon-like peptide 1 (GLP-1) |  | Over the course of up to 3 hours following study product intake | 
| Plasma peptide tyrosine (PYY) |  | Over the course of up to 3 hours following study product intake |