- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02977273
The Lunch Study: the Combined Effects of Food Texture and Portion Size on Intake
Meal size is strongly influenced by a number of external features of the food environment which can promote over-consumption, such as the availability of palatable energy dense foods and large portion sizes. The current research aimed to investigate whether natural food-based differences in texture could be used to slow down eating rate and reduce intake from large portions.
A four-session randomised crossover study assessed the effect of faster vs. slower eating rate, achieved through manipulating food texture, on ad-libitum consumption (weight and calories) of a meal, alone and in combination with variations in meal portion size (regular vs. large)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The current obesogenic environment is characterized by the abundance of palatable and high energy dense foods. Eating from large portions can promote sustained overcompensation at meal times. On the other hand, eating at a slower rate has been shown to reduce meal size, and food-based texture differences can slow eating rate. It is possible that texture-based differences in eating rate could be used to reduce energy intake in of foods that are served in large portions.
This study was conducted to quantify the effect of eating rate (fast vs. slow) on ad-libitum consumption of a meal, alone and in combination with variations in portion size (100 % 700 g vs 150 % 1050 g). The meal combinations were as follows:
Meal 1: thin/100% portion; Meal 2: thin/150% portion; Meal 3: thick/100% portion; Meal 4: thick /150% portion
Participants consumed the four test meals over four non-consecutive test sessions at the Clinical Nutrition Research Centre, with at least three days washout between each session. Each part followed a completely randomised full crossover design.
The primary objective was to assess ad libitum intake (both kcal and g) of the test meals, depending on the combination of food texture and energy density.
The secondary objectives were to assess the eating rate, oral processing characteristics, changes in rated appetite up to 90 minutes post-consumption and energy intake (kcal) for the rest of the test day (food diary), as a function of the test meal texture and energy density
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Singapore, Singapore, 117599
- Clinical Nutrition Research Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria:
- Aged between 21 and 50 years
- BMI < 30 kg/m2
Exclusion criteria:
- Individuals whose body weight has changed more than 5 kilograms in the last 12 months
- People who are taking insulin or medications known to affect glucose metabolism, appetite or energy metabolism
- Individuals who are currently dieting
- People with intolerances or allergies to study foods or test products, e.g. soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colourings or flavourings, etc
- Pregnant women
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Test Meal 1
Thin/100% portion
|
Thin textured rice meal (ground rice grains) served in a regular portion size (100 %: 700g)
|
Sperimentale: Test Meal 2
Thin/150% portion
|
Thin textured rice meal (ground rice grains) served in a larger portion size (150 %: 1050g)
|
Sperimentale: Test Meal 3
Thick/100% Portion
|
Thick textured rice meal (whole rice grains) served in a regular portion size (100 %: 700g)
|
Sperimentale: Test Meal 4
Thick/150% Portion
|
Thick textured rice meal (whole rice grains) served in a larger portion size (150 %: 1050g)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Ad libitum intake of the test meals - weight (g)
Lasso di tempo: Measued once for up to 20 minutes
|
The weight of the test meal that is consumed during the 20 minute session was recorded. There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time. |
Measued once for up to 20 minutes
|
Ad libitum intake of the test meals - calories (kcal)
Lasso di tempo: Measued once for up to 20 minutes
|
The weight of the meal consumed at each of the four test sessions was convert to calories using the meal energy density (which is known). There are four test sessions and participants eat one of the four test meals each session. The amount consumed was measured each time. |
Measued once for up to 20 minutes
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Variazioni dell'appetito nominale prima e dopo il consumo del pasto e fino a 90 minuti dopo il consumo
Lasso di tempo: prima del pasto, subito dopo il pasto, +15 minuti, +30 minuti, +45 minuti, +60 minuti, +75 minuti, + 90 minuti
|
Valutazioni VAS (Visual Analogue Scale) a 100 punti di fame, pienezza, desiderio di mangiare, consumo potenziale e sete
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prima del pasto, subito dopo il pasto, +15 minuti, +30 minuti, +45 minuti, +60 minuti, +75 minuti, + 90 minuti
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Apporto energetico (kcal) per il resto della giornata di test registrato in un diario alimentare
Lasso di tempo: Fino a 24 ore
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Assunzione di cibo registrata in un diario alimentare
|
Fino a 24 ore
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Eating rate of the test meal
Lasso di tempo: Measued once for up to 20 minutes
|
Video recordings of the participants eating are coded and from this eating rate was calculated as grams consumed per minute (g/min).
|
Measued once for up to 20 minutes
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2015/00867 Part 2
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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