Effect of Physical Form of Apples on Gastrointestinal Function and Satiety: a MRI Study

NCT03714464 | Completed

• 1 other identifier: A13102015 SoM SPMIC PhD
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Gastrointestinal Symptoms

Keywords

Gastrointestinal physiology; Gastrointestinal response to sugars; gastrointestinal; MRI; stomach; small bowel; sorbitol; excess fructose; FODMAPs; colon

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  every 45 minutes from 0 minutes until 315 minutes

• Mean breath hydrogen measured from baseline to 315 minutes

  every 45 minutes from 0 minutes until 315 minutes

Other Outcomes (2)

• Difference in symptom severity

  every 45 minutes from 0 minutes until 315 minutes for every intervention (whole apple, apple puree and apple juice)

• Difference in appetite

  every 45 minutes from 0 minutes until 315 minutes for every intervention (whole apple, apple puree and apple juice)

Study Arms (3)

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.

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.

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

Other: Apple Juice

Interventions

Whole apples OTHER

350 of whole apples containing 49g of available carbohydrate with 173ml water

Whole Apple

Apple puree OTHER

384g of apple puree containing 44g of available carbohydrates with 224 ml water

Apple Puree

Apple Juice OTHER

338g apple juice containing 46g of available carbohydrate with 260 ml water

Apple Juice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or older
• Able to give informed consent

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• University of Nottingham: lead
• King's College London: collaborator

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (13)

• 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.

  PMID: 23588241 BACKGROUND

• Gibson 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.

  PMID: 22488077 BACKGROUND

• Barrett 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.

  PMID: 20102355 BACKGROUND

• Murray 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.

  PMID: 24247211 BACKGROUND

• Placidi 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.

  PMID: 22582872 BACKGROUND

• Halmos 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.

  PMID: 24076059 BACKGROUND

• Ong 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.

  PMID: 20659225 BACKGROUND

• Staudacher 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.

  PMID: 22739368 BACKGROUND

• Staudacher 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.

  PMID: 24445613 BACKGROUND

• Haber 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.

  PMID: 71495 BACKGROUND

• Muir 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.

  PMID: 19123815 BACKGROUND

• Marciani 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.

  PMID: 20626735 BACKGROUND

• Krishnasamy 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.

  PMID: 32805050 DERIVED

Study Officials

• Robin Spiller, MD,FRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Principal investigators and co-investigators were blinded when measuring gastric volumes, small bowel water content and colonic volumes.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 22, 2018
• Study Start: February 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 22, 2018

Record last verified: 2017-08

Locations

GB (1)