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Slowly Digestible Carbohydrates for GLP-1 Secretion

1. mai 2026 oppdatert av: Bruce R. Hamaker, Purdue University

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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

19

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Indiana
      • West Lafayette, Indiana, Forente stater, 47907
        • Rekruttering
        • Clinical Research Center at Purdue University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Healthy population
  2. BMI between 18.5 and 24.9 kg/m2
  3. Adults 18 - 45 years old
  4. Men or women
  5. Able to read/speak English
  6. Fasting blood glucose levels ≤100 mg/dL
  7. HbA1c ≤ 5.7%

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Maltodextrin
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.
Kosttilskudd: Maltodextrin (Placebo)
75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
Andre navn:
  • Styre
Eksperimentell: Low-Dose SDC
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.
Kosttilskudd: Maltodextrin (Placebo)
75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
Andre navn:
  • Styre
Kosttilskudd: Raw Corn Starch
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).
Andre navn:
  • Slowly-Digestible Carbohydrate
  • Ileal-Digesting Starch
Eksperimentell: Medium-Dose SDC
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.
Kosttilskudd: Maltodextrin (Placebo)
75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
Andre navn:
  • Styre
Kosttilskudd: Raw Corn Starch
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).
Andre navn:
  • Slowly-Digestible Carbohydrate
  • Ileal-Digesting Starch
Eksperimentell: High-Dose SDC
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.
Kosttilskudd: Maltodextrin (Placebo)
75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
Andre navn:
  • Styre
Kosttilskudd: Raw Corn Starch
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).
Andre navn:
  • Slowly-Digestible Carbohydrate
  • Ileal-Digesting Starch

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total GLP-1 Secretion
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Satiety
Tidsramme: From baseline, 60, 120, 180 minutes and after a second meal for each participant over the course of the 4 arms.
Measure satiety at baseline, 60, 120, 180 minutes and after a second meal via satiety questionnaires
From baseline, 60, 120, 180 minutes and after a second meal for each participant over the course of the 4 arms.
Blood Glucose
Tidsramme: From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms
To determine the impact of 20, 40, 60 g of SDC compared to a maltodextrin control on total plasma glucose concentrations at baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of SDC. Assessed via spun blood serum.
From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms
Insulin
Tidsramme: From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms
To determine the impact of 20, 40, 60 g of SDC compared to a maltodextrin control on insulin concentrations at baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of SDC. Assessed via spun blood plasma.
From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Purdue University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

30. juli 2026

Studiet fullført (Antatt)

25. november 2026

Datoer for studieregistrering

Først innsendt

1. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-2025-00000283

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