Acceptability of Dietary Fibre-based Foods
27. března 2018 aktualizováno: Newcastle University
Acceptability of Dietary Fibre-based Foods to Reduce Dietary Fat Uptake
Obesity is a wide reaching problem in the United Kingdom. The most widely used obesity therapies are based around drugs that reduce dietary fat digestion, and thereby reduce uptake of calories from the diet. While such therapies have proved effective, patient compliance is low due to the unwanted gastrointestinal side effects of these drugs. Dietary fibre is generally classified as dietary material of plant origin that is indigestible to humans. Dietary fibre is in fact a wide range of different compounds that have varied effects on the human body. Initial findings from this laboratory suggest that some types of fibre can greatly reduce the rate that fat is digested and absorbed in the gut.
Whether such fibre-based test foods are acceptable (i.e. taste good, are easy to include in the diet and do not cause any unwanted gastrointestinal side effects) will be assessed in longer term studies. To carry these studies out, healthy adults will be recruited. Participants will attend an induction visit and will be asked to keep a food diary, and fill out daily questionnaires on general well-being and feelings of fullness over a two-week period whilst consuming the standard white bread given to them. Following this two-week period, participants will attend the study centre again. At this time, participants will be provided with dietary fibre-based study food (bread) to substitute into their standard diet over the following two weeks (further bread will be provided as and when required). Participants will fill out the same diaries and questionnaires as before over the first two week period.
Přehled studie
Detailní popis
This study aims to test the acceptability of fibre-based foods in terms of their palatability, ease of incorporation into the diet and the lack of unwanted side effects of consumption. To meet these aims, participants will be provided with bread to incorporate into their diet (by substituting like-for-like) over a two-week period. During this time, participants will record what they have eaten, along with their general feelings of well-being throughout this period. These measures will be compared to the same data collected over the two-week period prior to giving the participants the study foods (as a "background" measure of food intake and general well-being).
To carry these studies out, healthy adults will be recruited. Participants will attend an induction visit at Newcastle University where we will take informed consent. Participants will then be asked to keep a food diary, and fill out daily questionnaires on their general well-being and feelings of fullness for the entirety of the following two weeks whilst consuming the standard white bread given to them. Following this two-week period, participants will attend the study centre again and will be provided with dietary fibre-based study food (breads) to substitute into their standard diet over the following two weeks (further foods will be provided as and when required). They will fill out the same diaries and questionnaires as they did before over the first two week period.
The wellbeing questionnaire will be filled out by participants every day with a more detailed questionnaire completed at the end of each week. Volunteers will complete the more detailed questionnaire five times. Once at the start of the study (baseline) and then at then once at the end of each week consuming standard white bread and once at the end of each week consuming the alginate bread. The standard wellbeing questionnaire will be completed every day the volunteers are on the study.
Typ studie
Intervenční
Zápis (Aktuální)
54
Fáze
- Nelze použít
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- healthy participants
- over the age of 18
Exclusion Criteria:
- Individuals with a known allergy to any of the study foods
- Individuals who wish not to consume the study foods)
- Individuals who will not be able to consume their standard diet over the study period (e.g. due to holidays etc).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: Study cohort
Participants will receive standard white bread for two weeks and then alginate bread for two weeks.
All participants will receive the bread in the same order.
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White bread with 4% alginate (wet weight of dough) included into the bread.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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A change in side effects with consumption of alginate bread
Časové okno: Every day volunteers take part in the study (28 days)
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A change in the number gastrointestinal side effects described by the volunteers
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Every day volunteers take part in the study (28 days)
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A change in visual analogue scale (VAS) score of question: How have you been feeling today, alert or sleepy?
Časové okno: Measured once per day for 28 days
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Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
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Measured once per day for 28 days
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A change in visual analogue scale (VAS) score of question: How have you been feeling today, fine or nauseous?
Časové okno: Measured once per day for 28 days
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
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Measured once per day for 28 days
|
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A change in visual analogue scale (VAS) score of question: How have you been feeling today, full or starving?
Časové okno: Measured once per day for 28 days
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
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Measured once per day for 28 days
|
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A change in visual analogue scale (VAS) score of question: How have you been feeling today, not bloated or bloated?
Časové okno: Measured once per day for 28 days
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Measured once per day for 28 days
|
|
A change in visual analogue scale (VAS) score of question: How have you been feeling today, not flatulent or flatulent?
Časové okno: Measured once per day for 28 days
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Measured once per day for 28 days
|
|
A change in visual analogue scale (VAS) score of question: How have you been feeling today, calm or irritable?
Časové okno: Measured once per day for 28 days
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Measured once per day for 28 days
|
|
A change in visual analogue scale (VAS) score of question: How have you been feeling today, relaxed or anxious?
Časové okno: Measured once per day for 28 days
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Measured once per day for 28 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
A change in visual analogue scale (VAS) score of question: Have you been suffering from; light-headedness or dizziness, not at all or very?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
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A change in visual analogue scale (VAS) score of question: Have you been suffering from; Blurred Vision, not at all or very?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
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A change in visual analogue scale (VAS) score of question: Have you been suffering from; a difficulty to concentrate, not at all or very?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
|
A change in visual analogue scale (VAS) score of question: Have you been suffering from; excessive thirst, not at all or very?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
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A change in visual analogue scale (VAS) score of question: Have you been suffering from; headaches/migraines, not at all or very?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
|
A change in visual analogue scale (VAS) score of question: Have you been suffering from; cravings for sweets, not at all or very?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
|
A change in visual analogue scale (VAS) score of question: Have you been suffering from; abdominal discomfort, not at all or very?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
|
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: bowel habit, constipated or diarrhoea?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
|
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: urgency to pass stool, less than normal more than normal?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
|
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: abdominal pain or discomfort, no pain or terrible?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
|
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: amount of flatulence, less than normal or more than normal?
Časové okno: Once per week at the end of each study week (4 weeks)
|
Visual analogue scale (VAS) score between 0 - 10.
The VAS scale is 10 cm long horizontal line and measured from the left hand side.
The distance from the left hand side that the volunteer marks on the scale generates the score.
The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
|
Once per week at the end of each study week (4 weeks)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
19. ledna 2010
Primární dokončení (Aktuální)
18. ledna 2012
Dokončení studie (Aktuální)
18. ledna 2012
Termíny zápisu do studia
První předloženo
27. října 2017
První předloženo, které splnilo kritéria kontroly kvality
19. března 2018
První zveřejněno (Aktuální)
27. března 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. března 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. března 2018
Naposledy ověřeno
1. března 2018
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Proposal v4 04JAN2010
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
There is not a plan to make individual participant data available
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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