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

NCT05963594 | Completed

• 1 other identifier: 22.06.CLI
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Dietary Supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Total blood glucose AUC

  Over the course of 3 hours following study product intake

• Blood glucose (iCmax)

  Over the course of 3 hours following study product intake

• Blood glucose (Cmin)

  Over the course of 3 hours following study product intake

• Blood glucose (Tmax)

  Over the course of 3 hours following study product intake

• Blood glucose (Tmin)

  Over the course of 3 hours following study product intake

Other Outcomes (8)

• Plasma glucose at individual timepoints

  Over the course of 3 hours following study product intake

• Between-group comparison of changes in glucose slope

  From the time point at which maximum glucose level is measured to 3 hours

• Between group comparison of mean "Interquartile range"

  Over the course of 3 hours following study product intake

Study Arms (6)

T2D Sequence AB

ACTIVE COMPARATOR

Where A = 50 g Oligomalt and B = 50 g Glucidex 40.

Dietary Supplement: Oligomalt; Dietary Supplement: maltodextrin

T2D Sequence BA

ACTIVE COMPARATOR

Where A = 50 g Oligomalt and B = 50 g Glucidex 40.

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.

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.

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.

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.

Dietary Supplement: Oligomalt; Dietary Supplement: maltodextrin

Interventions

Oligomalt DIETARY_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.

HAO Sequence ABCD; HAO Sequence BDAC; HAO Sequence CADB; HAO Sequence DCBA; T2D Sequence AB; T2D Sequence BA

maltodextrin DIETARY_SUPPLEMENT

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.

Also known as: Glucidex 40

HAO Sequence ABCD; HAO Sequence BDAC; HAO Sequence CADB; HAO Sequence DCBA; T2D Sequence AB; T2D Sequence BA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Interventions

maltodextrin

Study Officials

• Joel Neutel, MD

  Orange County Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 27, 2023
• Study Start: January 23, 2023
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)