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Acute Effect of MMT Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes

16. marts 2022 opdateret af: Ong Ying Qian, Universiti Sultan Zainal Abidin

Acute Effect of Melon Manis Terengganu Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes

Open-label, randomised, placebo-controlled, crossover study with two intervention arms. The study was conducted in 30 respondents and the primary objective is to show an improved glycemic response after Melon Manis Terengganu (MMT) peel powder consumption in people at risk of type 2 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The main aim of the study is to investigate the acute effect of MMT peel powder on glycemic response in people at risk of type 2 diabetes. Besides, the acute effect of MMT peel powder on perceived satiety and energy intake were explored.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Malaysia
    • Terengganu
      • Kuala Terengganu, Terengganu, Malaysia, 21300
        • Food Preparation and Therapeutic Diet Lab, Faculty of Health Sciences, Universiti Sultan Zainal Abidin, Gong Badak Campus

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

18 år til 59 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Modified Finnish Type 2 Diabetes Risk Assessment Tool (FINDRISC) score ≥ 4
  • Capillary fasting blood glucose (FBG) < 7.0 mmol/L
  • Malaysian
  • Live, work or study in Kuala Nerus, Terengganu
  • Both gender
  • Age 18 to 59 years old
  • Non-smoker
  • Those taking supplement agree to undergo washout period of one week

Exclusion Criteria:

  • Had clinical history of type 2 diabetes mellitus (T2DM)
  • Capillary FBG ≥ 7.0 mmol/L
  • Take oral antidiabetic agents
  • Participate in other weight management programme or interventional research
  • On a prescribed medical diet
  • GI illnesses or conditions
  • Allergy or sensitivity to study products
  • Pregnant, currently breastfeeding, or planning to become pregnant
  • On dietary restrictions
  • Smoker

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: Formulation 3
Formulated MMT peel powder (provide 5 g dietary fiber per day)
Andet: Formulation 3
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
Andre navne:
  • Formulated MMT peel powder
Placebo komparator: Control
Glucose
Andet: Control
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
Andre navne:
  • Glukose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in fasting and postprandial blood glucose
Tidsramme: Day 1 and 4 of both study visits
Blood glucose were measured using glucometer (Accu Chek Performa, New South Wales, Australia) from finger-prick blood samples according to the standard operating procedure at baseline (0 min), 30, 60, 90 and 120 minutes.
Day 1 and 4 of both study visits

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in perceived satiety
Tidsramme: Day 1 and 4 of both study visits
Perceived satiety measurements were rated using a 10-cm visual analogue scale (VAS) which consisted of hunger (How hungry are you?), fullness (How full are you?), desire to eat (How strong is your desire to eat?), prospective food consumption (How much would you be able to eat right now?) and thirstiness (How thirsty are you?) (Tey, Salleh, Henry, & Forde, 2017). The scale ranged from 0 (not at all) to 10 (very much) measured at baseline (0 min), 30, 60, 90 and 120 minutes.
Day 1 and 4 of both study visits
Changes in food intake
Tidsramme: Day 1 and 4 of both study visits
The respondents were asked to record all the food or drink they had consumed including sauces, soup and gravies using household measures once they woke up in the morning until they went to sleep at night.
Day 1 and 4 of both study visits

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in body weight (kg)
Tidsramme: Day 1 and 4 of both study visits
Body weight was taken at every study visit.
Day 1 and 4 of both study visits
Changes in height (m)
Tidsramme: Day 1 and 4 of both study visits
Height was taken at every study visit.
Day 1 and 4 of both study visits
Changes in body mass index (BMI) (kg/m^2)
Tidsramme: Day 1 and 4 of both study visits
BMI was calculated using formula = body weight (kg)/height (m)^2
Day 1 and 4 of both study visits
Changes in % body fat
Tidsramme: Day 1 and 4 of both study visits
% body fat was taken at every study visit.
Day 1 and 4 of both study visits
Changes in waist circumference (cm)
Tidsramme: Day 1 and 4 of both study visits
Waist circumference was taken at every study visit.
Day 1 and 4 of both study visits
Changes in blood pressure
Tidsramme: Day 1 and 4 of both study visits
Blood pressure was measured using an Omron automatic digital blood pressure monitor (Omron HEM-7221) in a seated position at all visits after 5 min of sitting.
Day 1 and 4 of both study visits
Habitual food intake
Tidsramme: Day 0 before the first study visit start date
The respondents were instructed to complete a semi-quantitative Food Frequency Questionnaire (FFQ) which was adapted from the Malaysian Adult Nutrition Survey (MANS) (Institute for Public Health, 2014).
Day 0 before the first study visit start date
Habitual physical activity
Tidsramme: Day 0 before the first study visit start date
The physical activity of the respondents was measured by using the International Physical Activity Questionnaire-Short Version (IPAQ-SF) in Malay language that had been pilot tested and pre validated in National Health and Morbidity Survey 2011 (Teh et al., 2014)
Day 0 before the first study visit start date

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universiti Sultan Zainal Abidin

Samarbejdspartnere

Universiti Sains Malaysia
National University of Malaysia

Efterforskere

  • Ledende efterforsker: Prof Dr Sakinah Harith, Universiti Sultan Zainal Abidin
  • Ledende efterforsker: Dr Norshazila Shahidan, Universiti Sultan Zainal Abidin
  • Ledende efterforsker: Prof Madya Dr Mohd Razif Shahril, National University of Malaysia
  • Ledende efterforsker: Prof Madya Dr Hermizi Hapidin, Universiti Sains Malaysia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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)

1. oktober 2021

Primær færdiggørelse (Faktiske)

3. november 2021

Studieafslutning (Faktiske)

3. november 2021

Datoer for studieregistrering

Først indsendt

1. marts 2022

Først indsendt, der opfyldte QC-kriterier

16. marts 2022

Først opslået (Faktiske)

28. marts 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RCTOYQ

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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Placeringer

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