Gastrointestinal SymptomsNCT03714464
Effect of Physical Form of Apples on Gastrointestinal Function and Satiety: a MRI Study
A study testing Whole apples, Apple puree and Apple Juice in people with Gastrointestinal Symptoms, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Different physical form of apples had a significant effect on satiety and blood sugar levels which was shown in a 1977 study by Haber and his team (Haber et al.1977).It was suggested that , this effect was due to processing of the apples which modified the bioavailability of carbohydrate and fiber content.However this… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms
- What is being tested?
- Whole apples, Apple puree and Apple Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- Able to give informed consent
Who cannot join
- Aversion to the test product
- Unable to eat whole fruit due to poor dentition or other reasons
- Pregnancy and lactation declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
- A positive diagnosis of irritable bowel syndrome based on the Rome III criteria questionnaire
- Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
Show all 18Show fewer
- Intestinal stoma
- Any medical condition potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- Unable to limit alcohol intake to ≤ 35 units/ week and ≤ 8 units per day during trial and to avoid alcohol the day before each study day
- Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
- Antibiotic or prescribed probiotic treatment in the past 8 weeks
- Inability to lie flat or exceed scanner limits of weight <120kg
- Poor understanding of English language
- Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM
- Participation in any medical trials for the past 3 months
- Alteration in habitual diet in the last 6 months
- Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Different physical form of apples had a significant effect on satiety and blood sugar levels which was shown in a 1977 study by Haber and his team (Haber et al.1977).It was suggested that , this effect was due to processing of the apples which modified the bioavailability of carbohydrate and fiber content.However this was not enough to explain the mechanistic effect of the apples. Within the last decade, the role of magenetic resonance imaging has been very promising in understanding gastrointestinal function and physiology. Recent MRI studies have measured changes in gastrointestinal volumes due to the effect of fermentable carbohydrates.
Apple contains fermentable carbohydrates or FODMAPs. They are known to be poorly absorbed in the small and exert an osmotic effect by increasing markedly small bowel water content in the intestinal lumen as demonstrated in imaging studies.(Murray et al 2014 and Placidi et al 2012). A reduction of FODMAPs in the diet of IBS sufferers has been found to alleviate functional gut symptoms demonstrated in several randomised controlled trials.
In order to fully understand the 1977 Haber study, the investigators would like to repeat the study using modern MRI methods in healthy volunteers and measure the volume changes in the stomach, small bowel and colon. In addition appetite and symptoms would also be investigated after ingesting each test meal.
Read the detailed description
18 healthy volunteers will participate in this 3-way crossover study. They will attend one morning for each study, with the studies separated by approximately 1 week. We will measure breath hydrogen before the test meal, and after that approximately every hour for the next 5 h. We will also scan the subjects at baseline, immediately after the test meal and then approximately every hour for 5 hours postprandially. Subjects will be scanned on a research dedicated 1.5T MRI scanner. At baseline and every time the subjects come out of the MRI scanner we will ask them to rate their feelings of fullness, hunger and appetite as well their gastrointestinal symptoms on 100mm VAS scales. The subjects will be fed three types of Pink Lady apples test meals: whole apple, apple puree and apple juice. The apples will be sourced from supermarkets. The apple juice and apple puree will be prepared for this study by Campden BRI, a world famous food science research institute in Chipping Campden, UK. Each test meal will approximately provide 46g of available carbohydrate; 180kcal
- Conditions
- Gastrointestinal Symptoms
- Being tested
- Whole apples, Apple puree, Apple Juice
- Keywords
- Gastrointestinal physiology, Gastrointestinal response to sugars, gastrointestinal, MRI, stomach, small bowel, sorbitol, excess fructose, FODMAPs, colon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole applesOther
350 of whole apples containing 49g of available carbohydrate with 173ml water
Apple pureeOther
384g of apple puree containing 44g of available carbohydrates with 224 ml water
Apple JuiceOther
338g apple juice containing 46g of available carbohydrate with 260 ml water
| Study group | Role | What they receive |
|---|---|---|
| Whole Apple | Experimental | Participants will be given 350g of whole apple and 150 mls water to be consumed in 20 minutes.
Serial MRI of gastrointestinal tract is done every 45 minutes from baseline until 315 minutes. Receives: Other: Whole apples |
| Apple Puree | Experimental | Participants will be given 384g of apple puree and 150 mls water to be consumed in 20 minutes.
Serial MRI of gastrointestinal tract is done every 45 minutes from baseline until 315 minutes. Receives: Other: Apple puree |
| Apple Juice | Experimental | Participants will be given 338g of apple juice and 150 mls water to be consumed in 20 minutes.
Serial MRI of gastrointestinal tract is done every 45 minutes from baseline until 315 minutes Receives: Other: Apple Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference of small bowel water content (SBWC) in ml as measured by MRI from baseline to 315 minutes following ingestion of whole apple, apple puree and apple juice.
Small bowel water content will be measured in mililitres (ml) using in house software for every 45 minutes. Difference in means will be compared using repeated measure ANOVA.
Measured: every 45 minutes from 0 minutes until 315 minutes
Secondary outcomes (2)
Mean difference of gastric volume measured by MRI from baseline to 315 minutes minutes following ingestion of whole apple, apple puree and apple juice.
Gastric volume in milliliters will be measured using MRI software every 45 minutes.Difference in means will be compared using repeated measure ANOVA.
Measured: every 45 minutes from 0 minutes until 315 minutes
Mean breath hydrogen measured from baseline to 315 minutes
Breath hydrogen is measured in parts per million (ppm) using a breath hydrogen meter
Measured: every 45 minutes from 0 minutes until 315 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study startFeb 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal SymptomsStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention to be tested in this study is dietary intake of apples which are naturally high in fermentable carbohydrate. The investigators purchased the apples from a mainstream high street supermarket. The test meals consisted of whole apples (Meal A), apple puree (Meal B) and apple juice (Meal C)
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Robin Spiller, MD,FRCP, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714464
- Sponsor's protocol ID
- A13102015 SoM SPMIC PhD
- Status last verified
- Aug 2017
- First submitted
- 10 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shepherd SJ, Lomer MC, Gibson PR. Short-chain carbohydrates and functional gastrointestinal disorders. Am J Gastroenterol. 2013 May;108(5):707-17. doi: 10.1038/ajg.2013.96. Epub 2013 Apr 16.
PubMed 23588241Gibson PR, Shepherd SJ. Food choice as a key management strategy for functional gastrointestinal symptoms. Am J Gastroenterol. 2012 May;107(5):657-66; quiz 667. doi: 10.1038/ajg.2012.49. Epub 2012 Apr 10.
PubMed 22488077Barrett JS, Gearry RB, Muir JG, Irving PM, Rose R, Rosella O, Haines ML, Shepherd SJ, Gibson PR. Dietary poorly absorbed, short-chain carbohydrates increase delivery of water and fermentable substrates to the proximal colon. Aliment Pharmacol Ther. 2010 Apr;31(8):874-82. doi: 10.1111/j.1365-2036.2010.04237.x. Epub 2010 Jan 22.
PubMed 20102355Murray K, Wilkinson-Smith V, Hoad C, Costigan C, Cox E, Lam C, Marciani L, Gowland P, Spiller RC. Differential effects of FODMAPs (fermentable oligo-, di-, mono-saccharides and polyols) on small and large intestinal contents in healthy subjects shown by MRI. Am J Gastroenterol. 2014 Jan;109(1):110-9. doi: 10.1038/ajg.2013.386. Epub 2013 Nov 19.
PubMed 24247211Placidi E, Marciani L, Hoad CL, Napolitano A, Garsed KC, Pritchard SE, Cox EF, Costigan C, Spiller RC, Gowland PA. The effects of loperamide, or loperamide plus simethicone, on the distribution of gut water as assessed by MRI in a mannitol model of secretory diarrhoea. Aliment Pharmacol Ther. 2012 Jul;36(1):64-73. doi: 10.1111/j.1365-2036.2012.05127.x. Epub 2012 May 14.
PubMed 22582872Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
PubMed 24076059Ong DK, Mitchell SB, Barrett JS, Shepherd SJ, Irving PM, Biesiekierski JR, Smith S, Gibson PR, Muir JG. Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Aug;25(8):1366-73. doi: 10.1111/j.1440-1746.2010.06370.x.
PubMed 20659225Staudacher HM, Lomer MC, Anderson JL, Barrett JS, Muir JG, Irving PM, Whelan K. Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome. J Nutr. 2012 Aug;142(8):1510-8. doi: 10.3945/jn.112.159285. Epub 2012 Jun 27.
PubMed 22739368Staudacher HM, Irving PM, Lomer MC, Whelan K. Mechanisms and efficacy of dietary FODMAP restriction in IBS. Nat Rev Gastroenterol Hepatol. 2014 Apr;11(4):256-66. doi: 10.1038/nrgastro.2013.259. Epub 2014 Jan 21.
PubMed 24445613Haber GB, Heaton KW, Murphy D, Burroughs LF. Depletion and disruption of dietary fibre. Effects on satiety, plasma-glucose, and serum-insulin. Lancet. 1977 Oct 1;2(8040):679-82. doi: 10.1016/s0140-6736(77)90494-9.
PubMed 71495Muir JG, Rose R, Rosella O, Liels K, Barrett JS, Shepherd SJ, Gibson PR. Measurement of short-chain carbohydrates in common Australian vegetables and fruits by high-performance liquid chromatography (HPLC). J Agric Food Chem. 2009 Jan 28;57(2):554-65. doi: 10.1021/jf802700e.
PubMed 19123815Marciani L, Wright J, Foley S, Hoad CL, Totman JJ, Bush D, Hartley C, Armstrong A, Manby P, Blackshaw E, Perkins AC, Gowland PA, Spiller RC. Effects of a 5-HT(3) antagonist, ondansetron, on fasting and postprandial small bowel water content assessed by magnetic resonance imaging. Aliment Pharmacol Ther. 2010 Sep;32(5):655-63. doi: 10.1111/j.1365-2036.2010.04395.x.
PubMed 20626735Krishnasamy S, Lomer MCE, Marciani L, Hoad CL, Pritchard SE, Paul J, Gowland PA, Spiller RC. Processing Apples to Puree or Juice Speeds Gastric Emptying and Reduces Postprandial Intestinal Volumes and Satiety in Healthy Adults. J Nutr. 2020 Nov 19;150(11):2890-2899. doi: 10.1093/jn/nxaa191.
PubMed 32805050
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Form of Apples on Gastrointestinal Function and Satiety: a MRI Study
- ClinicalTrials.gov ID
- NCT03714464
- Acronym / sponsor ID
- A13102015 SoM SPMIC PhD
- Conditions
- Gastrointestinal Symptoms
- Keywords
- Gastrointestinal physiology, Gastrointestinal response to sugars, gastrointestinal, MRI, stomach, small bowel, sorbitol, excess fructose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Different physical form of apples had a significant effect on satiety and blood sugar levels which was shown in a 1977 study by Haber and his team (Haber et al.1977).It was suggested that , this effect was due to processing of the apples which modified the bioavailability of carbohydrate and fiber content.However this was not enough to explain the mechanistic effect of the apples. Within the last decade, the role of magenetic resonance imaging has been very promising in understanding gastrointestinal function and physiology. Recent MRI studies have measured changes in gastrointestinal volumes due to the effect of fermentable carbohydrates.
Apple contains fermentable carbohydrates or FODMAPs. They are known to be poorly absorbed in the small and exert an osmotic effect by increasing markedly small bowel water content in the intestinal lumen as demonstrated in imaging studies.(Murray et al 2014 and Placidi et al 2012). A reduction of FODMAPs in the diet of IBS sufferers has been found to alleviate functional gut symptoms demonstrated in several randomised controlled trials.
In order to fully understand the 1977 Haber study, the investigators would like to repeat the study using modern MRI methods in healthy volunteers and measure the volume changes in the stomach, small bowel and colon. In addition appetite and symptoms would also be investigated after ingesting each test meal.
Detailed description
18 healthy volunteers will participate in this 3-way crossover study. They will attend one morning for each study, with the studies separated by approximately 1 week. We will measure breath hydrogen before the test meal, and after that approximately every hour for the next 5 h. We will also scan the subjects at baseline, immediately after the test meal and then approximately every hour for 5 hours postprandially. Subjects will be scanned on a research dedicated 1.5T MRI scanner. At baseline and every time the subjects come out of the MRI scanner we will ask them to rate their feelings of fullness, hunger and appetite as well their gastrointestinal symptoms on 100mm VAS scales. The subjects will be fed three types of Pink Lady apples test meals: whole apple, apple puree and apple juice. The apples will be sourced from supermarkets. The apple juice and apple puree will be prepared for this study by Campden BRI, a world famous food science research institute in Chipping Campden, UK. Each test meal will approximately provide 46g of available carbohydrate; 180kcal
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The intervention to be tested in this study is dietary intake of apples which are naturally high in fermentable carbohydrate. The investigators purchased the apples from a mainstream high street supermarket. The test meals consisted of whole apples (Meal A), apple puree (Meal B) and apple juice (Meal C)
| Arm | Type | Receives |
|---|---|---|
| Whole Apple | Experimental | Other: Whole applesParticipants will be given 350g of whole apple and 150 mls water to be consumed in 20 minutes. Serial MRI of gastrointestinal tract is done every 45 minutes from baseline until 315 minutes. |
| Apple Puree | Experimental | Other: Apple pureeParticipants will be given 384g of apple puree and 150 mls water to be consumed in 20 minutes. Serial MRI of gastrointestinal tract is done every 45 minutes from baseline until 315 minutes. |
| Apple Juice | Experimental | Other: Apple JuiceParticipants will be given 338g of apple juice and 150 mls water to be consumed in 20 minutes. Serial MRI of gastrointestinal tract is done every 45 minutes from baseline until 315 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 or older
- Able to give informed consent
Key exclusion criteria (18 listed)
- Aversion to the test product
- Unable to eat whole fruit due to poor dentition or other reasons
- Pregnancy and lactation declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
- A positive diagnosis of irritable bowel syndrome based on the Rome III criteria questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole apples350 of whole apples containing 49g of available carbohydrate with 173ml water | Other | Whole Apple |
| Apple puree384g of apple puree containing 44g of available carbohydrates with 224 ml water | Other | Apple Puree |
| Apple Juice338g apple juice containing 46g of available carbohydrate with 260 ml water | Other | Apple Juice |
Primary outcome
Mean difference of small bowel water content (SBWC) in ml as measured by MRI from baseline to 315 minutes following ingestion of whole apple, apple puree and apple juice.
Time frame: every 45 minutes from 0 minutes until 315 minutes
Small bowel water content will be measured in mililitres (ml) using in house software for every 45 minutes. Difference in means will be compared using repeated measure ANOVA.
2 secondary outcomes
Mean difference of gastric volume measured by MRI from baseline to 315 minutes minutes following ingestion of whole apple, apple puree and apple juice.
Time frame: every 45 minutes from 0 minutes until 315 minutes
Mean breath hydrogen measured from baseline to 315 minutes
Time frame: every 45 minutes from 0 minutes until 315 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Background: PubMed 23588241Shepherd SJ, Lomer MC, Gibson PR. Short-chain carbohydrates and functional gastrointestinal disorders. Am J Gastroenterol. 2013 May;108(5):707-17. doi: 10.1038/ajg.2013.96. Epub 2013 Apr 16.
- Background: PubMed 22488077Gibson PR, Shepherd SJ. Food choice as a key management strategy for functional gastrointestinal symptoms. Am J Gastroenterol. 2012 May;107(5):657-66; quiz 667. doi: 10.1038/ajg.2012.49. Epub 2012 Apr 10.
- Background: PubMed 20102355Barrett JS, Gearry RB, Muir JG, Irving PM, Rose R, Rosella O, Haines ML, Shepherd SJ, Gibson PR. Dietary poorly absorbed, short-chain carbohydrates increase delivery of water and fermentable substrates to the proximal colon. Aliment Pharmacol Ther. 2010 Apr;31(8):874-82. doi: 10.1111/j.1365-2036.2010.04237.x. Epub 2010 Jan 22.
- Background: PubMed 24247211Murray K, Wilkinson-Smith V, Hoad C, Costigan C, Cox E, Lam C, Marciani L, Gowland P, Spiller RC. Differential effects of FODMAPs (fermentable oligo-, di-, mono-saccharides and polyols) on small and large intestinal contents in healthy subjects shown by MRI. Am J Gastroenterol. 2014 Jan;109(1):110-9. doi: 10.1038/ajg.2013.386. Epub 2013 Nov 19.
- Background: PubMed 22582872Placidi E, Marciani L, Hoad CL, Napolitano A, Garsed KC, Pritchard SE, Cox EF, Costigan C, Spiller RC, Gowland PA. The effects of loperamide, or loperamide plus simethicone, on the distribution of gut water as assessed by MRI in a mannitol model of secretory diarrhoea. Aliment Pharmacol Ther. 2012 Jul;36(1):64-73. doi: 10.1111/j.1365-2036.2012.05127.x. Epub 2012 May 14.
- Background: PubMed 24076059Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
- Background: PubMed 20659225Ong DK, Mitchell SB, Barrett JS, Shepherd SJ, Irving PM, Biesiekierski JR, Smith S, Gibson PR, Muir JG. Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Aug;25(8):1366-73. doi: 10.1111/j.1440-1746.2010.06370.x.
- Background: PubMed 22739368Staudacher HM, Lomer MC, Anderson JL, Barrett JS, Muir JG, Irving PM, Whelan K. Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome. J Nutr. 2012 Aug;142(8):1510-8. doi: 10.3945/jn.112.159285. Epub 2012 Jun 27.
- Background: PubMed 24445613Staudacher HM, Irving PM, Lomer MC, Whelan K. Mechanisms and efficacy of dietary FODMAP restriction in IBS. Nat Rev Gastroenterol Hepatol. 2014 Apr;11(4):256-66. doi: 10.1038/nrgastro.2013.259. Epub 2014 Jan 21.
- Background: PubMed 71495Haber GB, Heaton KW, Murphy D, Burroughs LF. Depletion and disruption of dietary fibre. Effects on satiety, plasma-glucose, and serum-insulin. Lancet. 1977 Oct 1;2(8040):679-82. doi: 10.1016/s0140-6736(77)90494-9.
- Background: PubMed 19123815Muir JG, Rose R, Rosella O, Liels K, Barrett JS, Shepherd SJ, Gibson PR. Measurement of short-chain carbohydrates in common Australian vegetables and fruits by high-performance liquid chromatography (HPLC). J Agric Food Chem. 2009 Jan 28;57(2):554-65. doi: 10.1021/jf802700e.
- Background: PubMed 20626735Marciani L, Wright J, Foley S, Hoad CL, Totman JJ, Bush D, Hartley C, Armstrong A, Manby P, Blackshaw E, Perkins AC, Gowland PA, Spiller RC. Effects of a 5-HT(3) antagonist, ondansetron, on fasting and postprandial small bowel water content assessed by magnetic resonance imaging. Aliment Pharmacol Ther. 2010 Sep;32(5):655-63. doi: 10.1111/j.1365-2036.2010.04395.x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Spiller, MD,FRCP principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole apples, Apple puree and Apple Juice in people with Gastrointestinal Symptoms, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference of small bowel water content (SBWC) in ml as measured by MRI from baseline to 315 minutes following ingestion of whole apple, apple puree and apple juice. (time frame: every 45 minutes from 0 minutes until 315 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03714464, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.