- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05145998
Metabolic Effects of Pulse Consumption on Biomarkers in Adults With Type 2 Diabetes or Met Syn (PGRIV)
23. november 2021 opdateret af: Donna Winham, Iowa State University
Metabolic Effects of Pulse Consumption on Biomarkers in Adults With Type 2 Diabetes Mellitus or Metabolic Syndrome
The purpose of this study is to determine glycemic response of four different meals containing either whole green peas, whole lentils, powdered green peas, or powdered lentils in comparison to Glucola.
Participants are adults with type 2 diabetes mellitus or metabolic syndrome.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The 5 test treatments (Glucola, whole green peas, green pea flour, whole lentils, and lentil flour) will be administered randomly over five weeks.
The test Participants will be required to consume the entire test treatment meal in 12 minutes while being observed.
Venous blood samples will be collected for blood glucose and insulin levels at time 0 (fasting) and at 30, 60, 90, 120, and 180 minutes post-treatment (timing of the post-treatment blood draws started at time 0 [post-treatment], which is when the participant finishes consuming the treatment meal).
During the first visit blood was drawn for a lipid panel and HbA1C values.
Thyroid stimulating hormone (TSH) and complete blood count (CBC) values were analyzed during the second visit, and vitamin D levels analyzed during the final visit.
Blood analysis was completed by a reputable biomarker diagnostics laboratory, Quest Diagnostics.
Anthropometric measures such as weight, height, waist circumference, and blood pressure were collected at screening and at the start of each test day.
Thirteen hours before testing, participants consumed a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes.
This control meal was selected by each participant before the start of the study.
Each participant was provided the same frozen meal every time, since the subjects serve as their own controls.
The day before test day, participants completed a 24 hour food recall, satiety, and gastrointestinal questionnaires.
The morning of each test day participants completed the International Physical Activity Questionnaire (IPAQ), satiety, and gastrointestinal questionnaires.
Test meal and blood glucose results at the 5 test points were entered into SPSS statistical software (V.
25) for data cleaning and analysis.
Physical activity and the 24 hour dietary recall data were used to classify individuals on activity and dietary quality.
Satiety responses were compared against each of the 5 test meals for each participant as well as the gastrointestinal responses using SPSS.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Iowa
-
Ames, Iowa, Forenede Stater, 50011
- Iowa State University, Food Science and Human Nutrition Department
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
24 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 24-70 years
- BMI between 22-40
- Medical diagnosis of type 2 diabetes
- HbA1C <10%)
- OR have 3+ indicators of metabolic syndrome (high triglycerides, low HDL-cholesterol, high blood pressure) plus prediabetes HbA1c.
Exclusion Criteria:
- Uncontrolled hypertension or other health issues, e.g., gastrointestinal disease
- Weight changes of >10% of participants body weight within a 6 month period
- Pregnant or breastfeeding
- Allergy to peas, lentils, tomatoes, gluten, or latex
- HgbA1c level of >10% at screening
- Unwillingness or inability to follow study protocol.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control - Glucola
Glucola control beverage
|
50 grams of Glucola sugar beverage
|
|
Eksperimentel: Whole peas
Whole cooked peas in a 50 gram carbohydrate meal dose
|
Whole cooked peas with spaghetti sauce and a slice of bread.
|
|
Eksperimentel: Pea Flour
Pea flour in a 50 gram carbohydrate meal dose
|
Pea flour with spaghetti sauce and a slice of bread.
|
|
Eksperimentel: Whole lentils
Whole cooked lentils in a 50 gram carbohydrate meal dose
|
Whole cooked lentils with spaghetti sauce and a slice of bread.
|
|
Eksperimentel: Lentil flour
Lentil flour in a 50 gram carbohydrate meal dose
|
Lentil flour with spaghetti sauce and a slice of bread.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in baseline blood glucose over 3 hours (glycemic response)
Tidsramme: Time 0 (fasting) then every 30 minutes for 3 hours
|
Venous blood samples were collected via venous catheter.
Whole blood samples were analyzed for glucose content and insulin at Quest Diagnostics.
|
Time 0 (fasting) then every 30 minutes for 3 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring i mæthedsfornemmelse
Tidsramme: Tid 0 (faste) derefter hvert 30. minut i 3 timer
|
Mæthedsniveau målt ved hjælp af en visuel analog skala (0-100) hvert 30. minut postprandialt.
En højere score indikerer større mæthed.
|
Tid 0 (faste) derefter hvert 30. minut i 3 timer
|
|
Change in gastrointestinal symptoms
Tidsramme: 3 hours postprandial, and 12 hours postprandial
|
Gastrointestinal concerns and changes were noted on a descriptive questionnaire
|
3 hours postprandial, and 12 hours postprandial
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Donna Winham, DrPH, Iowa State University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. maj 2018
Primær færdiggørelse (Faktiske)
29. februar 2020
Studieafslutning (Faktiske)
29. februar 2020
Datoer for studieregistrering
Først indsendt
16. januar 2020
Først indsendt, der opfyldte QC-kriterier
23. november 2021
Først opslået (Faktiske)
6. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17-191
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .