Acceptability of Dietary Fibre-based Foods
27 marzo 2018 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
54
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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.
|
White bread with 4% alginate (wet weight of dough) included into the bread.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
A change in side effects with consumption of alginate bread
Lasso di tempo: Every day volunteers take part in the study (28 days)
|
A change in the number gastrointestinal side effects described by the volunteers
|
Every day volunteers take part in the study (28 days)
|
|
A change in visual analogue scale (VAS) score of question: How have you been feeling today, alert or sleepy?
Lasso di tempo: 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, fine or nauseous?
Lasso di tempo: 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, full or starving?
Lasso di tempo: 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 bloated or bloated?
Lasso di tempo: 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?
Lasso di tempo: 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?
Lasso di tempo: 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?
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
A change in visual analogue scale (VAS) score of question: Have you been suffering from; light-headedness or dizziness, not at all or very?
Lasso di tempo: 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; Blurred Vision, not at all or very?
Lasso di tempo: 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; a difficulty to concentrate, not at all or very?
Lasso di tempo: 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?
Lasso di tempo: 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; headaches/migraines, not at all or very?
Lasso di tempo: 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?
Lasso di tempo: 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?
Lasso di tempo: 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?
Lasso di tempo: 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?
Lasso di tempo: 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?
Lasso di tempo: 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?
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
19 gennaio 2010
Completamento primario (Effettivo)
18 gennaio 2012
Completamento dello studio (Effettivo)
18 gennaio 2012
Date di iscrizione allo studio
Primo inviato
27 ottobre 2017
Primo inviato che soddisfa i criteri di controllo qualità
19 marzo 2018
Primo Inserito (Effettivo)
27 marzo 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 marzo 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 marzo 2018
Ultimo verificato
1 marzo 2018
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Proposal v4 04JAN2010
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
There is not a plan to make individual participant data available
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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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-
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