Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatment diet beverages
Sponsor John Sievenpiper
Start date November 2015
End date November 2016
Trial size 1 participant
Trial identifier NCT02879500, CIHR LCS vs water 2015

Summary

Sugars have been singled out as one of the prime culprits in the dual epidemics of obesity and diabetes. Artificially sweetened beverages (ASBs) provide a potentially important means for displacing excess calories from free sugars in the diet. There is, however, a concern that the use of ASBs may themselves contribute to an increased risk of obesity and diabetes. This concern led the 2015 Dietary Guidelines for American Committee (DGAC) to recommend that sugars in the diet not be replaced with ASBs but rather with "healthy options" such as water. Whether ASBs more than water will contribute to obesity and diabetes remains unclear. To address this important question, the investigators propose to conduct a series of systematic review and meta-analyses of the totality of the evidence from randomized controlled trials and prospective cohort studies to evaluate the effects of water and ASBs in the development of overweight and obesity. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence/base guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovations, and guiding future research design.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Incident overweight or obesity
time frame: Up to 20 years

Secondary Outcomes

Measure
Body weight
time frame: Up to 20 years
BMI
time frame: Up to 20 years

Eligibility Criteria

Male or female participants of any age.

1. RCTs Inclusion Criteria: - Trials in humans - Diet beverage intervention - Water comparator - Diet duration >= 7 days - Viable outcome data Exclusion Criteria: - Non-human trials - Observational studies - Lack of suitable comparator - Diet duration < 2 weeks - No viable outcome data 2. Cohort studies Inclusion Criteria: - Prospective cohort studies or case-cohort studies - Duration >= 1year - Assessment of the exposure of diet beverages or water - Ascertainment of viable data by level of exposure Exclusion Criteria: - Ecological, cross-sectional, and retrospective observational studies, clinical trials and non-human studies - Duration < 1 year - No assessment of exposures of diet beverages or water - No ascertainment viable clinical outcome data by level of exposure

Additional Information

Official title Artificially Sweetened Beverages Versus Water and Risk of Obesity: A Series of Systematic Reviews and Network Meta-analyses of Randomized Controlled Trials and Prospective Cohort Studies
Principal investigator John L Sievenpiper, MD, PhD, FRCPC
Description Background: Sugars have been singled out as one of the prime culprits in the dual epidemics of obesity and diabetes. Artificially sweetened beverages (ASBs) provide a potentially important means for displacing excess calories from free sugars in the diet. There is, however, a concern that the use of ASBs may themselves contribute to an increased risk of obesity and diabetes. This concern led the 2015 Dietary Guidelines for American Committee (DGAC) to recommend that sugars in the diet not be replaced with ASBs but rather with "healthy options" such as water. Whether ASBs more than water contribute to obesity remains unclear. Objective: The investigators will conduct a series of systematic reviews and meta-analyses to asses (1) the effect of ASBs versus water on incident overweight/obesity, body weight and BMI in randomized controlled trials and (2) the relation of ASBs versus water with incident overweight/obesity, body weight, and body mass index (BMI) in prospective cohort studies. Design: Each systematic review and meta-analysis will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms supplemented by hand searches of references of included studies. Abstracts will be included and no language restrictions will be used. Study selection: The investigators will include either randomized controlled trials (RCTs) -or prospective cohort studies. RCTs will be included if they are >=7 days duration and assess the effect of water versus ASBs on incident overweight/obesity, body weight, or body mass index (BMI). Prospective cohort studies will be included if they are >= 1-year duration and assess the relationship of water and ASBs with incident overweight/obesity, body weight, or BMI. Data extraction: Two or more investigators will independently extract relevant data and assess risk of bias using the Cochrane Risk of Bias Tool. All disagreements will be resolved by consensus. Standard computations and imputations will be used to derive missing variance data. Outcomes: Three outcomes will be assessed: (1) incidence of overweight/obesity, (2) body weight, and BMI. Data synthesis: Risk ratios (incident overweight/obesity) and mean differences (body weight and BMI) will be pooled for direct comparisons (ASBs versus water) and indirect comparisons (ASBs versus SSBs and water versus SSBs using SSBs as the common comparator). We will perform Bayesian Network-Meta Analysis (NMA). We will present the pooled estimates as posterior means and 95% credible intervals. We will also use NMA for sensitivity analysis to validate our findings from the conventional generic inverse variance random-effects models. The NMA will be conducted using Markov Chain Monte Carlo (MCMC) approach simulation using GeMTC-R package. Paired analyses will be applied for crossover trials. Heterogeneity will be assessed by the Cochran Q statistic and quantified by the I2 statistic. To explore sources of heterogeneity, the investigators will conduct sensitivity analyses, in which each study is systematically removed. If there are >=10 studies, then the investigators will also explore sources of heterogeneity by a priori subgroup analyses by health status (metabolic syndrome/diabetes, overweight, normal weight), dose (<=median intake, >median intake), baseline measurements (global and abdominal adiposity), randomization, study design (parallel, crossover), energy balance (positive, neutral, negative), follow-up (<=8 weeks, >8 weeks), risk of bias, and individual domains of risk of bias using meta-regression analyses. Meta-regression analyses will assess the significance of categorical and continuous subgroup analyses. When >=10 studies are available, publication bias will be investigated by inspection of funnel plots and formal testing using the Egger test and the Begg test. If publication bias is suspected, then the investigators will attempt to adjust for funnel plot asymmetry by imputing the missing study data using the Duval and Tweedie trim and fill method. Evidence Assessment: The quality and strength of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Knowledge translation plan: The results will be disseminated through interactive presentations at local, national, and international scientific meetings and publication in high impact factor journals. Target audiences will include the public health and scientific communities with interest in nutrition, diabetes, obesity and cardiovascular disease. Feedback will be incorporated and used to improve the public health message and key areas for future research will be defined. Applicant/Co-applicant Decision Makers will network among opinion leaders to increase awareness and participate directly as committee members in the development of future guidelines. Significance: The proposed project will aid in knowledge translation related to the role of ASBs in the development of overweight and obesity, strengthening the evidence-base for guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Toronto.