- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07932769
Effect of Meal Sequence and Eating Speed on Blood Glucose After Eating Western Breakfast Among Healthy Young Adults
Impact of Meal Sequence and Eating Speed on Postprandial Glycemic Response of an Isocaloric Western Breakfast Among Healthy Young Adults
The goal of this clinical trial is to investigate the effects of meal sequence(the order in which carbohydrates/starches and non-starchy vegetables are consumed) and eating speed(slow or fast) on postprandial blood glucose response in healthy young adults (n=22) aged 20-25 years. The main questions it aims to answer are:
- Does consuming carbohydrate-containing foods before or after non-starchy vegetables influence postprandial blood glucose response?
- Does eating a standardized breakfast slowly (over approximately 20 minutes) or quickly (over approximately 10 minutes) affect postprandial blood glucose response?
- Do meal sequence and eating speed together influence postprandial glycemic response? Researchers will compare four breakfast conditions combining two meal sequences (carbohydrate-first and non-starchy vegetable-first) with two eating speeds (slow and fast) to determine their individual and combined effects on postprandial metabolic responses.
Participants will:
- Consume a standardized, isocaloric Western-style breakfast under four different experimental conditions.
- Consume the breakfast in the assigned food order and within the specified eating duration during each experimental visit.
- Attend four experimental visits in a randomized order, with a washout period between visits.
- Provide blood samples before and at 30, 60, 90, and 120 minutes after breakfast consumption to assess blood glucose levels.
- Undergo assessment of serum insulin and triglyceride responses according to the study protocol.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Humaira Ashraf, M.Phil food & nutrition
- Telefonnummer: +92 3356312424
- E-post: humairaashraf602@gmail.com
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan
- University of Veterinary and Animal Sciences, Paksitan
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Ta kontakt med:
- Sanaullah Iqbal Associate Professor, FSHN,UVAS
- Telefonnummer: +923338981489
- E-post: sanaullah.iqbal@uvas.edu.pk
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Ta kontakt med:
- Humaira Ashraf M.phil Food and Nutrition
- Telefonnummer: +923356312424
- E-post: humairaashraf602@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Healthy male adults aged 18-25 years, with a BMI of 18.0-24.9 kg/m², without known diseases, regular medication use, or allergies to study food ingredients.
Exclusion Criteria:
Individuals with diabetes or other diagnosed diseases, those using medications, following specific diets, or having dietary restrictions or allergies to study food ingredients will be excluded.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Sequence 1: A-B-D-C
Arm 1 - Sequence 1 (A-B-D-C): A: Carbohydrate-first + slow eating (20 minutes); B: Carbohydrate-first + fast eating (10 minutes) ; C: Vegetable-first + slow eating (20 minutes) ; D: Vegetable-first + fast eating (10 minutes). Participants receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables, in the sequence as :carbohydrate-first with slow eating, carbohydrate-first with fast eating, vegetable-first with fast eating, and vegetable-first with slow eating, in that order, over four weekly visits. |
Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of the standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. |
|
Eksperimentell: Sequence 2: B-C-A-D
Arm 2: Sequence 2 (B-C-A-D) A: Carbohydrate-first + slow eating (20 minutes); B: Carbohydrate-first + fast eating (10 minutes) ; C: Vegetable-first + slow eating (20 minutes) ; D: Vegetable-first + fast eating (10 minutes). Experimental arm. Participants receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables, in the following order: carbohydrate-first with fast eating, vegetable-first with slow eating, carbohydrate-first with slow eating, and vegetable-first with fast eating. |
Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of the standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. |
|
Eksperimentell: Sequence 3: C-D-B-A
Arm 3 - Sequence 3 (C-D-B-A): A: Carbohydrate-first + slow eating (20 minutes); B: Carbohydrate-first + fast eating (10 minutes) ; C: Vegetable-first + slow eating (20 minutes) ; D: Vegetable-first + fast eating (10 minutes). Participants receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables, in the sequence as: vegetable-first with slow eating, vegetable-first with fast eating, carbohydrate-first with fast eating, and carbohydrate-first with slow eating, in that order, over four weekly visits. |
Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of the standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. |
|
Eksperimentell: Sequence 4: D-A-C-B A:
Arm 4: Sequence 4 (D-A-C-B) Experimental arm: A: Carbohydrate-first + slow eating (20 minutes); B: Carbohydrate-first + fast eating (10 minutes) ; C: Vegetable-first + slow eating (20 minutes) ; D: Vegetable-first + fast eating (10 minutes). Participants receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables in the following order: vegetable-first with fast eating, carbohydrate-first with slow eating, vegetable-first with slow eating, and carbohydrate-first with fast eating. |
Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of the standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Postprandial Blood Glucose Incremental Area Under the Curve (iAUC) from 0 to 120 Minutes Across Four Breakfast Conditions
Tidsramme: At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each of the four intervention visits (approximately 4 weeks).
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Measurement details: Blood glucose concentrations measured at baseline (0 minutes) and 30, 60, 90, and 120 minutes after breakfast consumption. The incremental area under the curve (iAUC) will be calculated to compare postprandial glycemic responses across the four conditions. |
At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each of the four intervention visits (approximately 4 weeks).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postprandial Serum Insulin Response Across Four Breakfast Conditions.
Tidsramme: At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each intervention visit.
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Serum insulin concentrations will be assessed following consumption of each breakfast condition to evaluate differences in postprandial insulin responses associated with meal sequence and eating speed. |
At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each intervention visit.
|
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Postprandial Serum Triglyceride Response Across Four Breakfast Conditions
Tidsramme: At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each intervention visit.
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Serum triglyceride concentrations will be assessed following consumption of each breakfast condition to compare postprandial lipid responses associated with meal sequence and eating speed. |
At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each intervention visit.
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- MealSequence-GlycemicResponse
Plan for individuelle deltakerdata (IPD)
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