Evidence map›Paper›PMID 26747458›Full record

Trial reportNutrition journal2016

Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction.

V R Trivedi, M C Satia, A Deschamps, V Maquet, R B Shah, P H Zinzuwadia, J V Trivedi

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrition journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Dual Mechanistic Anti-Obesity Effects of Red Okra andJournal of microbiology and biotechnology · 2025
    Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. International journal of food science · 2020
    Article
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

V R TrivediEthicare Clinical Trial Services, Titanium City Centre, 100 Feet Road, Ahmedabad, 380015, Ahmedabad, India. vandittrivedi@ethicare-cro.com.
M C SatiaEthicare Clinical Trial Services, Titanium City Centre, 100 Feet Road, Ahmedabad, 380015, Ahmedabad, India. milansatia@ethicare-cro.com.
A DeschampsKITOZYME, Parc Industriel des Hauts-Sart, Zone 2, Rue de Milmort 680, 4040, Herstal, Belgium. a.deschamps@kitozyme.com.
V MaquetKITOZYME, Parc Industriel des Hauts-Sart, Zone 2, Rue de Milmort 680, 4040, Herstal, Belgium. v.maquet@kitozyme.com.
R B ShahPoojan Multispecialty Hospital, Gurukul Road, Memnagar, Ahmedabad, 380052, India. poojan.research@gmail.com.
P H ZinzuwadiaDHL Research Centre, Nr. Shivranjani Cross Roads, Satellite, Ahmedabad, 380015, India. drpadmanabh@rediffmail.com.
J V TrivediSAL Hospital, Drive-in Road, Ahmedabad, 380054, India. drjvtrivedi@rediffmail.com.
KitoZyme (Belgium) · BESterling Hospitals · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChitosan is a dietary fibre which acts by reducing fat absorption and thus used as a means for controlling weight. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. The primary objective of the present study was to evaluate the efficacy and safety of a chitosan from fungal origin in treatment of excess weight in the absence of dietary restrictions.

methodsA phase IV, randomised, multicentre, single-blind, placebo-controlled, clinical study was conducted by administering chitosan capsules (500 mg, five/day) and indistinguishable placebo capsules as daily supplements to 96 overweight and obese subjects for 90 days. The study participants were divided in 2:1 ratio to receive either chitosan (n = 64) or placebo (n = 32). Efficacy was assessed by measuring body weight, body composition parameters, anthropometric measurements, HbA1C level and lipid profile at day 45 and day 90. Also, short form-36 quality of life (QoL) questionnaire was assessed to evaluate improvement in life-style and dietary habits were recorded for calorie intake. Safety was assessed by evaluating safety parameters and monitoring adverse events.

resultsThe mean changes in body weight were -1.78 ± 1.37 kg and -3.10 ± 1.95 kg at day 45 and day 90 respectively in chitosan group which were significantly different (p < 0.0001) as compared to placebo. BMI was decreased by10.91 fold compared to placebo after 90 day administration. In concert with this, there was also reduction in body composition and anthropometric parameters together with improvement in QoL score. Chitosan was also able to reduce HbA1C levels (below 6 %) in subjects who had initial higher values. The mean caloric intake shows that there was no change in dietary habits of subjects in both groups. Lipid levels were unaffected and all adverse events were mild in nature and unrelated to study treatment.

conclusionChitosan from fungal origin was able to reduce the mean body weight up to 3 kg during the 90 day study period. Together with this, there was also improvement in body composition, anthropometric parameters and HbA1C, reflecting overall benefits for the overweight individuals. Additionally, there was also improvement in QoL score. It was safe and well tolerated by all subjects.

trial registrationCTRI/2014/08/004901.

Indexed as

Weight LossAdolescentAdultAgedBody CompositionBody Mass IndexChitosanDietary SupplementsDose-Response Relationship, DrugEndpoint DeterminationEnergy IntakeFeeding BehaviorFemaleGlycated HemoglobinHumansLife StyleChitosanGlycated HemoglobinPyridinesV 10367

Identifiers

PMID26747458
PMCPMC4706713
OpenAlexW2228905427

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.