Status:
COMPLETED
To Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With T2D and in HAO
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Dietary Supplement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 overw...
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05963594
Start Date
January 23 2023
End Date
March 28 2023
Last Update
July 27 2023
Active Locations (1)
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1
Orange County Research Center
Tustin, California, United States, 92780