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

Not Applicable

Completed

• Conditions: Dietary Supplement
• Interventions: Dietary Supplement: Oligomalt; Dietary Supplement: maltodextrin

• Registration Number: NCT05963594
• Lead Sponsor: Société des Produits Nestlé (SPN)

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 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 Timeline

• Study Start: 2023-01-23
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Study First Submitted: 2023-06-21
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

1. Type 1 diabetes.
2. Known food allergy or intolerance to study products.
3. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments.
4. 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.
5. 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.
6. 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).
7. Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors).
8. Current treatment with systemic steroids (application of inhaled or topical steroids is permitted).
9. Recent episode of an acute gastrointestinal illness.
10. 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.
11. Current daily cigarette smoking.
12. Are unable to comply with protocol procedures in the opinion of the investigator.
13. Have a hierarchical link with the research team members.
14. Positive pregnancy test or breast-feeding at screening.
15. 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.
16. 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:

1. Willing and able to sign written informed consent prior to study entry.
2. Male or female, >18 years of age.
3. BMI ≥ 25 kg/m2.
4. Fasting plasma glucose (FPG) ≤ 125 mg/dL.

Exclusion criteria:

1. Type 1 or type 2 diabetes (including those potentially detected at screening).
2. 2-h plasma glucose ≥ 200 mg/dL - if measured within 6 weeks prior to screening.
3. Known food allergy or intolerance to study products.
4. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments.
5. 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.
6. 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.
7. Current use of injectable insulin therapy, any oral or injectable glucose-lowering drug.
8. Current use of weight loss interventions or treatment with anorectic drugs (e.g., GLP-1 receptor analogues).
9. Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors).
10. Current treatment with systemic steroids (application of inhaled or topical steroids is permitted).
11. Recent episode of an acute gastrointestinal illness.
12. 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.
13. Current daily cigarette smoking.
14. Are unable to comply with protocol procedures in the opinion of the investigator.
15. Positive pregnancy test or breast-feeding at screening.
16. 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.
17. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HAO Sequence CADB	Oligomalt	Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
T2D Sequence AB	Oligomalt	Where A = 50 g Oligomalt and B = 50 g Glucidex 40.
HAO Sequence ABCD	Oligomalt	Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
T2D Sequence AB	maltodextrin	Where A = 50 g Oligomalt and B = 50 g Glucidex 40.
HAO Sequence ABCD	maltodextrin	Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
HAO Sequence BDAC	Oligomalt	Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
HAO Sequence BDAC	maltodextrin	Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
HAO Sequence DCBA	Oligomalt	Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
HAO Sequence DCBA	maltodextrin	Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
T2D Sequence BA	maltodextrin	Where A = 50 g Oligomalt and B = 50 g Glucidex 40.
HAO Sequence CADB	maltodextrin	Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
T2D Sequence BA	Oligomalt	Where A = 50 g Oligomalt and B = 50 g Glucidex 40.

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Orange County Research Center; 🇺🇸 Tustin, California, United States