NCT07572513

Brief Summary

The goal of this clinical trail is to learn if the hormone, glucagon-like peptide-1 (GLP-1), is stimulated by slowly digestible carbohydrates (SDCs) in healthy adults. In the current study, researchers will observe the amount of SDC that results in clinically meaningful levels of GLP-1, shown by an increase in feelings of fullness and a decrease in hunger, and how long an elevated level of GLP-1 lasts after starch consumption. Researchers aim to address two questions: What amount of SDC maximizes GLP-1-mediated satiety, and does the impact to satiety continue in a second meal? The overall goal is to maximize ileal-digesting SDC's potential use as a food-based agent for weight loss. Researchers will compare 20, 40, and 60 g of raw corn starch compared to a maltodextrin control on total plasma GLP-1 concentrations, insulin, and blood glucose at baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of SDC. Researchers will also measure satiety at baseline, 60, 120, 180 minutes and after a second meal. There will be a total of 4 study visits with a least a 7-day break between visits. At each study visit, participants will:

  • Consume a randomized test beverage (SDC or maltodextrin)
  • Receive a blood draw at 7 timepoints over 3 hrs
  • Take a satiety questionnaire 5 times over 3 hrs
  • Consume a standardized lunch 3 hrs after the test beverage consumption

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Nov 2026

First Submitted

Initial submission to the registry

May 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Blood GlucoseGLP-1SatietySecond Meal IntakeHealthy Participant Study

Keywords

GLP-1Slowly-Digestible StarchIleal-Digesting StarchDietary StarchSatietyStarchraw corn starchBlood Glucose

Outcome Measures

Primary Outcomes (1)

  • Total GLP-1 Secretion

    To determine the impact of 20, 40, 60 g of SDC compared to a maltodextrin control on total plasma GLP-1 concentrations at baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of SDC. Assessed via spun blood plasma and ELISA Total GLP-1 Kits.

    From baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of treatment for each participant over the course of the 4 arms.

Secondary Outcomes (3)

  • Satiety

    From baseline, 60, 120, 180 minutes and after a second meal for each participant over the course of the 4 arms.

  • Blood Glucose

    From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms

  • Insulin

    From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms

Study Arms (4)

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin increases GLP-1 from 0-60 minutes but doesn't have an extended or elevated plasma GLP-1 into 2-3 hrs post-consumption. Participants will consume a treatment that is either entirely maltodextrin or partially maltodextrin during each of the 4 study visits.

Dietary Supplement: Maltodextrin (Placebo)

Low-Dose SDC

EXPERIMENTAL

20 g of raw corn starch (SDC) + 55g of maltodextrin = 75 g total Researchers hypothesize that raw corn starch will have an extended or elevated plasma GLP-1 into 2-3 hrs post-consumption. Participants will consume the low-dose once during one of the study visits.

Dietary Supplement: Maltodextrin (Placebo)Dietary Supplement: Raw Corn Starch

Medium-Dose SDC

EXPERIMENTAL

40 g of raw corn starch (SDC) + 35g of maltodextrin = 75 g total Researchers hypothesize that raw corn starch will have an extended or elevated plasma GLP-1 into 2-3 hrs post-consumption. Participants will consume the medium-dose once during one of the study visits.

Dietary Supplement: Maltodextrin (Placebo)Dietary Supplement: Raw Corn Starch

High-Dose SDC

EXPERIMENTAL

60 g of raw corn starch (SDC) + 15g of maltodextrin = 75 g total Researchers hypothesize that raw corn starch will have an extended or elevated plasma GLP-1 into 2-3 hrs post-consumption. Participants will consume the high-dose once during one of the study visits.

Dietary Supplement: Maltodextrin (Placebo)Dietary Supplement: Raw Corn Starch

Interventions

Maltodextrin (Placebo)DIETARY_SUPPLEMENT

75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit

Also known as: Control
High-Dose SDCLow-Dose SDCMaltodextrinMedium-Dose SDC
Raw Corn StarchDIETARY_SUPPLEMENT

Quantity of raw corn starch will vary between low, medium, and high-dose treatment arms (20, 40, 60 g respectively). Each treatment will total 75 g using maltodextrin to account for mass difference (55, 35, 15 g respectively).

Also known as: Slowly-Digestible Carbohydrate, Ileal-Digesting Starch
High-Dose SDCLow-Dose SDCMedium-Dose SDC

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy population
  • BMI between 18.5 and 24.9 kg/m2
  • Adults 18 - 45 years old
  • Men or women
  • Able to read/speak English
  • Fasting blood glucose levels ≤100 mg/dL
  • HbA1c ≤ 5.7%

You may not qualify if:

  • Participants with 18 \> Years of Age \> 45 will be excluded.
  • Subjects with 18.5 kg/m² \> BMI \> 24.9 kg/m² will be excluded.
  • Diabetic individuals will be excluded.
  • Individuals with history of gastrointestinal disease will be excluded from the study.
  • Pregnant or nursing women will also be excluded.
  • Individuals taking GLP-1 medications, or on weight-loss diets or restrictive eating patterns.
  • Individuals suffering from dairy or gluten intolerance or allergies will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center at Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

MeSH Terms

Interventions

maltodextrinStarch

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Central Study Contacts

Bruce R Hamaker, Ph.D.

CONTACT

765-494-5668hamakerb@purdue.edu

Erica de Jong, B.s.

CONTACT

7654963802dejonge@purdue.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, acute, crossover, double-blinded, clinical trial (RCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

November 25, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)