Comparison of Taste and Palatability in Fiber Supplements
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The purpose of this study is to compare 1. taste and 2. texture/palatability of Metamucil
      orange®, Volcolon® and generic orange psyllium.
    

Detailed description: 
      Background of the study:

      A pleasant taste of a prescription improves patient compliance and adherence. According to
      the literature, only 50% of patients who suffer from chronic diseases adhere to treatment
      recommendations (1). This results in suboptimal outcomes (2). There are numerous factors that
      affect adherence, including characteristics of the illness, interaction between physician and
      patient, the complexity and duration of treatment, side effects of treatment and costs of
      treatment (3). Furthermore, medication palatability is also crucial for adherence. Several
      studies have addressed the palatability of medication for different disorders, like
      hypertension, HIV and Alzheimer's disease (4-6). Therefore, pharmaceutical companies pay
      attention to manufacture more formulations and add pleasant flavours which may improve the
      palatability. Fiber supplements are increasingly used for treatment of chronic constipation
      both in adults and children. In the Netherlands several formulas are available such as
      Metamucil orange®, Volcolon® en generic psyllium orange. These are effective and save
      formulas. Little literature is available concerning taste and laxatives or fibers, although
      many patients complain about taste and texture of the preparations. Studies with polyethylene
      glycol preparations performed by our research group demonstrated some differences in
      palatability between these preparations (7-9). There are hardly any studies about fibers and
      taste. The taste is mentioned to be acceptable; one study compares dried prunes with psyllium
      and concludes there is no difference in taste experience (10). In order to improve patient
      compliance, it is of clinical importance to know which preparations are the most acceptable
      to the patient, and use that as first choice. We hypothese that the taste and palatability of
      Metamucil orange® is preferable.

      Objective of the study:

      Comparison of 1. taste and 2. texture/palatability of Metamucil orange®, Volcolon® and
      generic orange psyllium.

      Study design:

      It is a double blind, randomized, crossover study.

      Study population:

      100 healthy volunteers (primary recruitment of medical students).

      Intervention: All healthy volunteers will try the 3 different formulas. After swallowing the
      first formula, the mouth will be rinsed with water. Then the second formula will be tried,
      after rinsing the mouth again the third formula will be tried. Every time after tasting a
      formula, the questionnaire is filled in, before starting with the next formula. The maximum
      intake is 3 x 25 ml (75 ml), this is 37,5% of one dosage advised quantity of fibre. The
      sequence in which the formulas are tasted is randomized.

      Preparations and dosage

      Each sachet needs to be solved in a glass of water. This matches (approximately) 200 ml.
      During the study the volunteers will taste 3 x 25 ml of water. This matches 37,5% of one
      dosage. The average intake of psyllium fibers is 1-3 sachets a day. Dosage if the different
      products:

        -  Volcolon sugar free (Dutch name: Volcolcolon suikervrij): 1 sachet contains 4 g powder o
           980mg/g psyllium fibers x 4 g per sachet = 3.92 g psyllium fibers/sachet o So 25 ml
           contains 0.490 g psyllium fibers

        -  Metamucil Orange: 1 sachet contains 3.4 g psyllium fibers o So 25 ml contains 0.425 g
           psyllium fibers

        -  Psyllium Orange: 1 sachet contains 3.25 g psyllium fibers o So 25 ml contains 0.406 g
           psyllium fibers These three products are the most used products for each brand
           (Metamucil orange, Volcolon and generic orange). This leads to the greatest coverage of
           the three brands in the Netherlands. The volunteers will swallow 25 ml of each product,
           three in total. This leads to an intake of 1.32 g (0.490 g + 0.425 g + 0.406= 1.32 g)
           psyllium fibers.

      According to the Dutch Board of Health (in Dutch: Gezondheidsraad) the average intake of
      fibers should be between 30 and 40 g a day. So, the volunteers will swallow approximately 4%
      (3.3 - 4.4%) of the advised intake of fibers. Therefore, we do not expect any problems when
      the volunteers swallow these products.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness (if applicable): The maximum intake is 3 x 25 ml (75 ml), this is 37,5% of one
      dosage advised quantity of fibre. Therefore, we do not expect any problems when the
      volunteers swallow these products.

      References:

        1. World Health Organisation. Adherence to long term therapies: evidence for action. 2003.

        2. Osterberg L, Blaschke T. Adherence to medication 1. N Engl J Med 2005 August
           4;353(5):487-97.

        3. Ingersoll KS, Cohen J. The impact of medication regimen factors on adherence to chronic
           treatment: a review of literature 1. J Behav Med 2008 June;31(3):213-24.

        4. Van der Linden D, Callens S, Brichard B, Colebunders R. Pediatric HIV: new opportunities
           to treat children 1. Expert Opin Pharmacother 2009 August;10(11):1783-91.

        5. Meier CM, Simonetti GD, Ghiglia S, Fossali E, Salice P, Limoni C et al. Palatability of
           angiotensin II antagonists among nephropathic children 1. Br J Clin Pharmacol 2007
           May;63(5):628-31.

        6. Yan YD, Woo JS, Kang JH, Yong CS, Choi HG. Preparation and evaluation of taste-masked
           donepezil hydrochloride orally disintegrating tablets 1. Biol Pharm Bull
           2010;33(8):1364-70.

        7. Felt-Bersma R.J., Kooyman G., Kuipers E.J. Colonic lavage prior to colonoscopy:
           comparable outcomes of two polyethylene-glycol preparations and a sodium-phosphate
           solution. Ned Tijdschr Geneeskd. 2004 Jan 24; 148 (4): 181-5

        8. Szojda MM, Mulder CJ, Felt-Bersma RJ. Differences in taste between two polyethylene
           glycol preparations.J Gastrointestin Liver Dis. 2007;16(4):379-81

        9. Lam TJ, Mulder CJ, Felt-Bersma RJ. Differences in taste between three polyethylene
           glycol preparations: a randomized double-blind study. Patient Prefer Adherence.
           2011;5:423-6.

       10. Yan YD, Woo JS, Kang JH, Yong CS, Choi HG. Preparation and evaluation of taste-masked
           donepezil hydrochloride orally disintegrating tablets 1. Biol Pharm Bull
           2010;33(8):1364-70.
    

Intervention name(s): Volcolon sugar free; Metamucil Orange; Psyllium Orange
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 sachet contains 4 g powder 980mg/g psyllium fibers x 4 g per sachet = 3.92 g psyllium fibers/sachet; 1 sachet contains 3.4 g psyllium fibers So 25 ml contains 0.425 g psyllium fibers; 1 sachet contains 3.25 g psyllium fibers So 25 ml contains 0.406 g psyllium fibers
Intervention MeSH terms: Psyllium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Fibers; Constipation