Dataset Information

Effectiveness and safety of light vegetarian diet on functional constipation with gastrointestinal damp-heat pattern: An exploratory study protocol for randomized controlled trial.

ABSTRACT:

Introduction

Functional constipation (FC) is one of the common gastrointestinal disorders that affects people of almost every age. Persistent FC significantly affects quality of life and well-being along with economic burden on patients as well as health care system. Therapeutic efficacy of currently used treatment strategies becomes limited shortly after their discontinuation as constipation occurs again as a result of inappropriate dietary habits. Previous studies have revealed that light vegetarian diet (LVD) can significantly improve both typical and atypical subtypes of major traditional Chinese medicine (TCM) FC syndrome such as gastrointestinal damp-heat syndrome. This protocol aims at exploratorily investigating effectiveness and safety of LVD following a rigorous clinical trial.

Methods and design

Total 92 patients in each of the 2 subtypes will be recruited in China-Japan Friendship Hospital for participating in this prospective, placebo-controlled, randomized trial and exploratory study. The patients in each subtype will be randomly divided into 4 groups according to 1:1:1:1 ratio with allocation concealment, which are drug + diet group, drug group, placebo + diet group and placebo group. Patients in the group with diet intervention will be required to strictly follow the LVD. The study will continue for a period of 28 days, including a drug or placebo supervised intervention and a 14th-day telephone follow-up. During the intervention, patients will be required to record a designed diary for controlling the diet quality (DQ) and analyzing the defecation. The study will focus investigation of complete spontaneous bowel movements (CSBM) per week as its primary outcome and constipation-related symptom rating scale (CSS), TCM syndrome scale (TCMSS), 48-hour gastrointestinal transit time (48-hour GITT), high resolution anorectal manometry (HRAM) and fecal flora detection (FFD) will be included in secondary outcomes. Furthermore, the study will also determine safety, DQ and compliance indicators.

Ethics and dissemination

This study has been approved by China-Japan Friendship Hospital clinical research ethics committee (No. 2017-46-1). A SPIRIT checklist is available for this protocol.

Trial registration number

ChiCTR1800019686 in Chinese Clinical Trial Registry (WHO ICTRP member).

SUBMITTER: Liu Y

PROVIDER: S-EPMC6922355 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Publications

Effectiveness and safety of light vegetarian diet on functional constipation with gastrointestinal damp-heat pattern: An exploratory study protocol for randomized controlled trial.

Liu Yu Y Gao Xudong X Ding Yuehua Y Zhou Yuanchen Y Liu Xinyuan X Wang Huijing H Wang Qianqian Q Ma Bingzhi B Yao Shukun S

Medicine 20191201 50

<h4>Introduction</h4>Functional constipation (FC) is one of the common gastrointestinal disorders that affects people of almost every age. Persistent FC significantly affects quality of life and well-being along with economic burden on patients as well as health care system. Therapeutic efficacy of currently used treatment strategies becomes limited shortly after their discontinuation as constipation occurs again as a result of inappropriate dietary habits. Previous studies have revealed that li ...[more]

PMID: 31852124

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Project description:Background: Sub-inflammation and insulin resistance characterize women with PCOS. Data on dietary modulation of inflammation among PCOS women is scant, particularly from Indian subcontinent. The present study aimed to assess the effect of plant based vs. animal origin diets on serum markers of inflammation (primary outcome measure). Methods: This observational case-control study compared age and BMI matched PCOS and apparently healthy women from two populations following different dietary practices. The vegetarian women from New-Delhi (n = 82 PCOS and n = 179 healthy) and non-vegetarian women from Srinagar (n = 62 PCOS and n = 141 healthy) formed the groups. Using a uniform methodology, detailed clinical, biochemical, hormonal, and inflammatory marker assessment was undertaken. Results: The mean age of the overall cohort was 26.23 ± 4.59 years with a mean BMI of 24.39 ± 3.72 kg/m2. Overall pro-inflammatory markers (TNF-α, IL-6, IL-1β, hs-CRP and serum resistin) were significantly higher (p ≤ 0.05) and anti-inflammatory markers (IL-10 and adiponectin) were lower among women with PCOS than healthy subjects. On comparing vegetarian women with non-vegetarians, higher daily calorie intake (1895.46 ± 258.19 vs. 1860.13 ± 323.96 Kcal) with a higher protein and fat and lower carbohydrate intake was recorded in the latter, although the percent energy derived from carbohydrates was higher among vegetarians. Clinical and biochemical parameters were comparable among the groups except mFG score, total serum testosterone and serum lipid levels which were higher among non-vegetarian women as compared to their vegetarian counterparts from both categories (PCOS and healthy). Interestingly, vegetarian women with PCOS and healthy women had higher serum pro-inflammatory and lower anti-inflammatory markers compared to their non-vegetarian counterparts. Conclusion: Women with PCOS consuming Indian vegetarian diet have higher pro-inflammatory and lower anti-inflammatory marker levels than their age and BMI matched healthy non-vegetarian counterparts. This interesting observation can be attributed to the dietary composition, among other factors and needs confirmation from well-designed randomized studies on a larger cohort. Clinical Trial Registration: The study was registered with CTRI database under registration number CTRI/2013/09/003996.

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Dataset Information

Effectiveness and safety of light vegetarian diet on functional constipation with gastrointestinal damp-heat pattern: An exploratory study protocol for randomized controlled trial.

Introduction

Methods and design

Ethics and dissemination

Trial registration number

Publications

Effectiveness and safety of light vegetarian diet on functional constipation with gastrointestinal damp-heat pattern: An exploratory study protocol for randomized controlled trial.

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