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临床试验/NCT03257449
NCT03257449Unknown不适用

Effect of Viscous Soluble Fibres on Body Weight Parameters: Review and Meta-analyses

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 1,268 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,268
试验地点
1
主要终点
Body weight chang

研究概览

简要总结

Abstract:

Background: Obesity is a global pandemic affects all age groups and is independent risk factors for most chronic diseases. Dietary intervention is an essential component of obesity management. Dietary fibre supplements have the potential to facilitate weight reduction based on their viscosity. Up to date, the evidence of effects of some fibres on weight is inadequate, and literature provides insufficient information about the effects of the fibre viscosity in weight management.

Objective: Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the effectiveness of viscous fibres, (agar, alginate, b-glucan from oat and barley, guar gum, glucomannan, pectin, PGX, psyllium), on body weight reduction.

Methods: Only randomised controlled trials are accepted. The trails must have one of the selected fibres as a supplement, and the outcomes must have body weight, BMI, waist circumference, or body fat percentage. Studies shorter than 4 weeks are excluded. Three databases, (Medline, EMBASE, and Cochrane library), were searched through 04/03/2016.

Results: After removing duplicates, 82 studies will be reviewed in full. Significance: This meta-analysis is the first meta-analysis that is based on fibre viscosity, and it will quantify the effect of each fibre in improving weight loss. It will also direct future research in the best direction to further explore this area.

详细描述

Background: Obesity is a global pandemic and is an independent risk factor for chronic disease. Dietary intervention is an essential component of obesity management. Observational studies show an inverse relationship between dietary fibres and body weight. Therefore, supplements of dietary fibres have the potential to facilitate weight reduction, possibly on the basis of the viscous properties of the fibre. Viscosity is the ability of gel forming that holds water and increase satiety and decreases the amount of intake food. This ability makes dietary fibre supplements considered as appetite suppressants. To date, the evidence of the effect of dietary fibre on weight is inconsistent and controversial and may be dependent on the ability of fibre to induce viscosity. Three previous meta-analyses on Konjac show inconsistency on the effect and its significance. In addition, other meta-analyses on individual viscous fibres show that some viscous fibre does not has an effect on body weight. This is the first meta-analysis that studies the effect of all these fibres together based on their viscosity.

Objective

Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the effect of viscous and non-viscous fibres on body weight, BMI, waist circumference, and body fat percentage.

Methods: To meet eligibility criteria, the study should be: randomized, controlled, include one of the selected fibres (agar, alginate, b-glucan from oat and barley, guar gum, konjac, pectin, PGX, Psyllium, and xanthan) as a supplement and one of the required outcomes (body weight, BMI, waist circumference or body fat percentage). Studies shorter than 4 weeks in duration will be excluded. Three databases (Medline, EMBASE, and Cochrane Library) were searched. After the search, a title/abstract screening was done to exclude the ineligible articles before extracting data from full eligible studies. Data were extracted using a PROFORMA. Review Manager 5.3 (RevMan) was used to carry out the analysis using generic inverse variance method (GIVM). Change from baseline and standard deviation were utilized in random effect model to get the pooled mean difference effect. Subgroup analyses were done using meta-regression in STATA to explore confounders. GRADE approach was conducted to evaluate the quality of evidence and the strength of recommendations.

Results: Databases were searched through 04/03/2016 and updated on 11/04/2017. Twenty-seven studies were eligible for analyses . The overall effect of viscous fibres on body weight was a significant reduction of -0.38 kg [95%CI: -0.3, -0.13] (P=0.003). BMI, waist circumference and body fat were also significantly reduced: -0.41 kg/m2 [95% CI: -0.61, -0.21](p = 0.0001) -0.78 cm[95%CI: -1.33, -0.24] (p = ) and -1.28 %[95% CI: -2.09, -0.46] (p = ), respectively.

Significance: This study is the first systematic review and meta-analysis that evaluated separately the effect of viscous and non-viscous fibres on weight in the general population. The analysis may help guide diet recommendations for obesity and identify the effect of fibres to direct future research this area.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Must be a randomized controlled clinical trial with either a parallel or cross-over design
  • Must have a treatment period of at least 4 week.
  • Healthy children and adults, overweight and obese individuals or individuals with diabetes were all acceptable
  • Must have one of the selected viscous fibres, (agar, alginate, β-glucan, guar gum, pectin, polyglycoplex(PGX), Psyllium, Xanthan), as a supplemented treatment.
  • Only β-glucan sources from barley or oat were accepted The amount of barley product or barley β-glucan must be reported or measured, or must be computable. β-glucan was considered to be 4.75% in barley, and 3-5% in oat.
  • Must be appropriately controlled.
  • Must measure one of outcomes: body weight, BMI, waist circumference, or Body fat percentage.
  • These Anthropometry measures can be either primary or secondary outcomes.
  • Enough information must be provided to calculate the magnitude of effect, i.e. end of treatment measures and/or change from baseline measures
  • Ad lipitum diet only.

排除标准

  • If the soluble fibre was not one of the selected viscous fibre or a combination.
  • supplement where these fibers could not be isolated each one alone.
  • If the study was insufficiently controlled, i.e. the control was another soluble fibre.
  • If the outcome measures did not include body weight, BMI, waist circumference, or Body fat percentage.
  • If the intervention was a diet with no supplemented fibre.
  • If the study provided insufficient information to calculate a magnitude of effect
  • If the study protocol maintains baseline weight.
  • Secondary information such as reviews, editorials, commentaries, were excluded
  • If the diet is hypo-caloric, energy restricted diet, or metabolically controlled diet.

结局指标

主要结局

Body weight chang

时间窗: in 4 weeks or more

unit of measure: Kg

Waist circumference change

时间窗: in 4 weeks or more

unit of measure: Cm

Body fat percentage change

时间窗: in 4 weeks or more

unit of measure: %

BMI change

时间窗: in 4 weeks or more

unit of measure: Kg/m2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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