AdiposityNCT04245826
Meta-analysis of Low-calorie Sweetened Beverages and Cardiometabolic Outcomes
An observational study of Adiposity and Metabolic Syndrome, run by University of Toronto at 1 site in Canada.
Trial summary
We propose to conduct a systematic literature review and meta-analysis to assess the association of low-calorie sweetened beverages (LCSBs) on cardiometabolic outcomes in prospective cohort studies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adiposity, Metabolic Syndrome, Type 2 Diabetes
- What is being tested?
- Change in LCSBs Intake and Substitute LCSBs for SSBs or Water
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2019to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Varies
Who may be able to join
- Prospective cohorts studies
- Duration: more than 1 year follow-up
- Exposure: LCSBs
- Change analysis or substitution analysis of exposure
Who cannot join
- Non-human studies
- Less than 1 year follow-up
- Analysis of baseline or prevalent intake of exposure only
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5C 2T2
About this study
Official title: Changing or Substituting Low-calorie Sweetened Beverages for Sugar-Sweetened Beverages or Water and Cardiometabolic Outcomes: A Systematic Review and Meta-analysis of Prospective Cohort Studies
We propose to conduct a systematic literature review and meta-analysis to assess the association of low-calorie sweetened beverages (LCSBs) on cardiometabolic outcomes in prospective cohort studies. We will be using methodological approaches (change in LCSBs intake, and/or substitution analysis) that attempt to overcome the issue of reverse causality associated with studies of LCSBs and cardiometabolic disease. Ten cardiometabolic outcomes will be assessed:
- Global adiposity - body weight
- Global adiposity - BMI
- Global adiposity - body fat
- Abdominal adiposity - waist circumference
- Overweight/obesity incidence
- Metabolic syndrome incidence
- Type 2 diabetes incidence
- Cardiovascular disease incidence
- Cardiovascular disease mortality
- Total mortality
Read the detailed description
Background:
Low-calorie sweetened beverages (LCSBs) may provide a potentially important means for displacing excess calories from free sugars in the diet. However, prospective cohort studies suggest that the use of LCSBs may contribute to an increased risk of obesity and diabetes. These findings are likely due to methodological limitations of study design and analysis that do not account for reverse causality, where higher risk of cardiometabolic outcomes may lead to people to switch to LCSBs. There is a need for a systematic review and meta-analysis (SRMA) of prospective cohort studies to overcome these methodological limitations.
Objective:
We will conduct a SRMA of prospective cohort studies in human subjects that have assessed cardiometabolic outcomes using two analytical strategies:
- Assessment of change in intake of LCSBs with change in outcome (change analysis) ii) Assessment of substitution of LCSBs for sugar-sweetened beverages (SSBs) or water.
Design:
We will conduct a SRMA according to the Cochrane Handbook for Systematic Reviews of Interventions and report the findings according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines.
Data sources:
MEDLINE, EMBASE, and the Cochrane Library databases will be searched using appropriate search terms, supplemented by hand searches of references of included studies. No restriction will be placed on language.
Study selection:
Prospective cohort studies reporting (a) change analysis (change in intake of LCSBs with the change in outcome), and/or (b) substitution analysis (substitution of SSBs with LCSBs or water) with more than 1-year of follow-up will be used. Cohort studies that have a follow-up duration <1 year, do not report assessment of exposure, or do not provide viable outcome data by level of exposure will be excluded.
Data extraction
Two or more investigators will independently extract relevant data and assess risk of bias using the Newcastle-Ottawa Scale (NOS) for prospective cohorts. All disagreements will be resolved by consensus. Risk ratios (RRs), odds ratios (ORs) and hazard ratios (HRs) for clinical outcomes in the prospective cohort studies will be extracted or derived from clinical event data across exposure categories.
Outcomes:
Ten cardiometabolic health outcomes will be assessed:
- Global adiposity - body weight
- Global adiposity - BMI
- Global adiposity - body fat
- Abdominal adiposity - waist circumference
- Overweight/obesity incidence
- Metabolic syndrome incidence
- Type 2 diabetes incidence
- Cardiovascular disease incidence
- Cardiovascular disease mortality
- Total mortality
Data synthesis:
Natural log-transformed RRs or HRs of clinical outcomes, comparing extreme quantiles (the highest exposure versus the lowest exposure or reference group), will be pooled separately using the generic inverse variance method with random effects models and expressed as RRs with 95% confidence intervals (CIs). Heterogeneity will be tested by Cochran's Q statistic and quantified by the I2 statistic. To explore sources of heterogeneity, we will conduct sensitivity analyses, in which each study is systematically removed. If ≥10 cohort comparisons are available, then we will perform an a-priori subgroup analyses by meta-regression for follow-up (<10 years vs. ≥10 years), sex (males vs. females, males vs. mixed, females vs. mixed), study quality (NOS <6 vs. ≥6) and funding source. Significant unexplained heterogeneity will be investigated by additional post hoc subgroup analyses and influence analysis. A study will be considered influential if it changes the direction or significance of the pooled estimates or the evidence of heterogeneity. Dose response estimates will be pooled using one-stage linear mixed model. When ≥10 studies are available, publication bias will be investigated by inspection of funnel plots and formal testing using the Egger and Begg tests. If publication bias is suspected, we 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 overall certainty of evidence for each outcome will be assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE).
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 to the role of the LCSBs role as a replacement strategy for SSBs, strengthening the evidence-base for guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.
- Being tested
- Change in LCSBs Intake, Substitute LCSBs for SSBs or Water
- Keywords
- body weight, BMI, waist circumference, diabetes, cardiovascular disease, metabolic syndrome, mortality, overweight incidence, obesity incdience
- Medical subject headings
- Obesity, Metabolic Syndrome, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Body Weight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in LCSBs IntakeOther
Effect of changing LCSBs intake
Substitute LCSBs for SSBs or WaterOther
Effect of substituting LCSBs for SSBs or Water
| Study group | Role | What they receive |
|---|---|---|
| Low-calorie Sweetened Beverages (LCSBs) | Beverages exclusively using zero-energy (e.g., acesulfame-potassium, aspartame, cyclamate, saccharin, sucralose, advantame, neotame), and /or reduced-energy food additives (e.g., stevia, monk fruit). Receives: Other: Change in LCSBs Intake; Other: Substitute LCSBs for SSBs or Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global measures of adiposity with established clinical relevance - body weight
Change in body weight
Measured: More than 1 year
Global measures of adiposity with established clinical relevance - BMI
Change in body mass index (BMI)
Measured: More than 1 year
Global measures of adiposity with established clinical relevance - body fat
Change in body fat
Measured: More than 1 year
Abdominal measures of adiposity with established clinical relevance - waist circumference
Change in waist circumference
Measured: More than 1 year
Overweight/obesity incidence
Risk ratio of Overweight/obesity incidence
Measured: More than 1 year
Metabolic syndrome incidence
Risk ratio of metabolic syndrome incidence
Measured: More than 1 year
Type 2 diabetes incidence
Risk ratio of type 2 diabetes incidence
Measured: More than 1 year
Cardiovascular disease incidence
Risk ratio of cardiovascular disease incidence
Measured: More than 1 year
Cardiovascular disease mortality
Risk ratio of Cardiovascular disease mortality
Measured: More than 1 year
Total mortality
Risk ratio of total mortality
Measured: More than 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start16 May 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Sievenpiper, University of Toronto
- Investigators
- John L Sievenpiper, MD,PhD,FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245826
- Sponsor's protocol ID
- DNSG-LCSBs (cohorts)
- Status last verified
- Feb 2020
- First submitted
- 23 Jan 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan TA, Malik VS, Sievenpiper JL. Letter by Khan et al Regarding Article, "Artificially Sweetened Beverages and Stroke, Coronary Heart Disease, and All-Cause Mortality in the Women's Health Initiative". Stroke. 2019 Jun;50(6):e167-e168. doi: 10.1161/STROKEAHA.119.025571. Epub 2019 May 16. No abstract available.
PubMed 31092156Malik VS. Non-sugar sweeteners and health. BMJ. 2019 Jan 3;364:k5005. doi: 10.1136/bmj.k5005. No abstract available.
PubMed 30606710Johnson RK, Lichtenstein AH, Anderson CAM, Carson JA, Despres JP, Hu FB, Kris-Etherton PM, Otten JJ, Towfighi A, Wylie-Rosett J; American Heart Association Nutrition Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Quality of Care and Outcomes Research; and Stroke Council. Low-Calorie Sweetened Beverages and Cardiometabolic Health: A Science Advisory From the American Heart Association. Circulation. 2018 Aug 28;138(9):e126-e140. doi: 10.1161/CIR.0000000000000569.
PubMed 30354445Toews I, Lohner S, Kullenberg de Gaudry D, Sommer H, Meerpohl JJ. Association between intake of non-sugar sweeteners and health outcomes: systematic review and meta-analyses of randomised and non-randomised controlled trials and observational studies. BMJ. 2019 Jan 2;364:k4718. doi: 10.1136/bmj.k4718.
PubMed 30602577Azad MB, Abou-Setta AM, Chauhan BF, Rabbani R, Lys J, Copstein L, Mann A, Jeyaraman MM, Reid AE, Fiander M, MacKay DS, McGavock J, Wicklow B, Zarychanski R. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies. CMAJ. 2017 Jul 17;189(28):E929-E939. doi: 10.1503/cmaj.161390.
PubMed 28716847Imamura F, Fretts A, Marklund M, Ardisson Korat AV, Yang WS, Lankinen M, Qureshi W, Helmer C, Chen TA, Wong K, Bassett JK, Murphy R, Tintle N, Yu CI, Brouwer IA, Chien KL, Frazier-Wood AC, Del Gobbo LC, Djousse L, Geleijnse JM, Giles GG, de Goede J, Gudnason V, Harris WS, Hodge A, Hu F; InterAct Consortium; Koulman A, Laakso M, Lind L, Lin HJ, McKnight B, Rajaobelina K, Riserus U, Robinson JG, Samieri C, Siscovick DS, Soedamah-Muthu SS, Sotoodehnia N, Sun Q, Tsai MY, Uusitupa M, Wagenknecht LE, Wareham NJ, Wu JH, Micha R, Forouhi NG, Lemaitre RN, Mozaffarian D; Fatty Acids and Outcomes Research Consortium (FORCE). Fatty acid biomarkers of dairy fat consumption and incidence of type 2 diabetes: A pooled analysis of prospective cohort studies. PLoS Med. 2018 Oct 10;15(10):e1002670. doi: 10.1371/journal.pmed.1002670. eCollection 2018 Oct.
PubMed 30303968Rogers PJ, Hogenkamp PS, de Graaf C, Higgs S, Lluch A, Ness AR, Penfold C, Perry R, Putz P, Yeomans MR, Mela DJ. Does low-energy sweetener consumption affect energy intake and body weight? A systematic review, including meta-analyses, of the evidence from human and animal studies. Int J Obes (Lond). 2016 Mar;40(3):381-94. doi: 10.1038/ijo.2015.177. Epub 2015 Sep 14.
PubMed 26365102Lee JJ, Khan TA, McGlynn N, Malik VS, Hill JO, Leiter LA, Jeppesen PB, Rahelic D, Kahleova H, Salas-Salvado J, Kendall CWC, Sievenpiper JL. Relation of Change or Substitution of Low- and No-Calorie Sweetened Beverages With Cardiometabolic Outcomes: A Systematic Review and Meta-analysis of Prospective Cohort Studies. Diabetes Care. 2022 Aug 1;45(8):1917-1930. doi: 10.2337/dc21-2130.
PubMed 35901272
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing or Substituting Low-calorie Sweetened Beverages for Sugar-Sweetened Beverages or Water and Cardiometabolic Outcomes: A Systematic Review and Meta-analysis of Prospective Cohort Studies
- ClinicalTrials.gov ID
- NCT04245826
- Acronym / sponsor ID
- DNSG-LCSBs (cohorts)
- Keywords
- body weight, BMI, waist circumference, diabetes, cardiovascular disease, metabolic syndrome, mortality, overweight incidence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to conduct a systematic literature review and meta-analysis to assess the association of low-calorie sweetened beverages (LCSBs) on cardiometabolic outcomes in prospective cohort studies. We will be using methodological approaches (change in LCSBs intake, and/or substitution analysis) that attempt to overcome the issue of reverse causality associated with studies of LCSBs and cardiometabolic disease. Ten cardiometabolic outcomes will be assessed:
- Global adiposity - body weight
- Global adiposity - BMI
- Global adiposity - body fat
- Abdominal adiposity - waist circumference
- Overweight/obesity incidence
- Metabolic syndrome incidence
- Type 2 diabetes incidence
- Cardiovascular disease incidence
- Cardiovascular disease mortality
- Total mortality
Detailed description
Background:
Low-calorie sweetened beverages (LCSBs) may provide a potentially important means for displacing excess calories from free sugars in the diet. However, prospective cohort studies suggest that the use of LCSBs may contribute to an increased risk of obesity and diabetes. These findings are likely due to methodological limitations of study design and analysis that do not account for reverse causality, where higher risk of cardiometabolic outcomes may lead to people to switch to LCSBs. There is a need for a systematic review and meta-analysis (SRMA) of prospective cohort studies to overcome these methodological limitations.
Objective:
We will conduct a SRMA of prospective cohort studies in human subjects that have assessed cardiometabolic outcomes using two analytical strategies:
- Assessment of change in intake of LCSBs with change in outcome (change analysis) ii) Assessment of substitution of LCSBs for sugar-sweetened beverages (SSBs) or water.
Design:
We will conduct a SRMA according to the Cochrane Handbook for Systematic Reviews of Interventions and report the findings according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines.
Data sources:
MEDLINE, EMBASE, and the Cochrane Library databases will be searched using appropriate search terms, supplemented by hand searches of references of included studies. No restriction will be placed on language.
Study selection:
Prospective cohort studies reporting (a) change analysis (change in intake of LCSBs with the change in outcome), and/or (b) substitution analysis (substitution of SSBs with LCSBs or water) with more than 1-year of follow-up will be used. Cohort studies that have a follow-up duration <1 year, do not report assessment of exposure, or do not provide viable outcome data by level of exposure will be excluded.
Data extraction
Two or more investigators will independently extract relevant data and assess risk of bias using the Newcastle-Ottawa Scale (NOS) for prospective cohorts. All disagreements will be resolved by consensus. Risk ratios (RRs), odds ratios (ORs) and hazard ratios (HRs) for clinical outcomes in the prospective cohort studies will be extracted or derived from clinical event data across exposure categories.
Outcomes:
Ten cardiometabolic health outcomes will be assessed:
- Global adiposity - body weight
- Global adiposity - BMI
- Global adiposity - body fat
- Abdominal adiposity - waist circumference
- Overweight/obesity incidence
- Metabolic syndrome incidence
- Type 2 diabetes incidence
- Cardiovascular disease incidence
- Cardiovascular disease mortality
- Total mortality
Data synthesis:
Natural log-transformed RRs or HRs of clinical outcomes, comparing extreme quantiles (the highest exposure versus the lowest exposure or reference group), will be pooled separately using the generic inverse variance method with random effects models and expressed as RRs with 95% confidence intervals (CIs). Heterogeneity will be tested by Cochran's Q statistic and quantified by the I2 statistic. To explore sources of heterogeneity, we will conduct sensitivity analyses, in which each study is systematically removed. If ≥10 cohort comparisons are available, then we will perform an a-priori subgroup analyses by meta-regression for follow-up (<10 years vs. ≥10 years), sex (males vs. females, males vs. mixed, females vs. mixed), study quality (NOS <6 vs. ≥6) and funding source. Significant unexplained heterogeneity will be investigated by additional post hoc subgroup analyses and influence analysis. A study will be considered influential if it changes the direction or significance of the pooled estimates or the evidence of heterogeneity. Dose response estimates will be pooled using one-stage linear mixed model. When ≥10 studies are available, publication bias will be investigated by inspection of funnel plots and formal testing using the Egger and Begg tests. If publication bias is suspected, we 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 overall certainty of evidence for each outcome will be assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE).
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 to the role of the LCSBs role as a replacement strategy for SSBs, strengthening the evidence-base for guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-calorie Sweetened Beverages (LCSBs) | – | Other: Change in LCSBs Intake, Other: Substitute LCSBs for SSBs or WaterBeverages exclusively using zero-energy (e.g., acesulfame-potassium, aspartame, cyclamate, saccharin, sucralose, advantame, neotame), and /or reduced-energy food additives (e.g., stevia, monk fruit). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Varies
Key inclusion criteria (4 listed)
- Prospective cohorts studies
- Duration: more than 1 year follow-up
- Exposure: LCSBs
- Change analysis or substitution analysis of exposure
Key exclusion criteria (3 listed)
- Non-human studies
- Less than 1 year follow-up
- Analysis of baseline or prevalent intake of exposure only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in LCSBs IntakeEffect of changing LCSBs intake | Other | Low-calorie Sweetened Beverages (LCSBs) |
| Substitute LCSBs for SSBs or WaterEffect of substituting LCSBs for SSBs or Water | Other | Low-calorie Sweetened Beverages (LCSBs) |
Primary outcome
Global measures of adiposity with established clinical relevance - body weight
Time frame: More than 1 year
Change in body weight
Global measures of adiposity with established clinical relevance - BMI
Time frame: More than 1 year
Change in body mass index (BMI)
Global measures of adiposity with established clinical relevance - body fat
Time frame: More than 1 year
Change in body fat
Abdominal measures of adiposity with established clinical relevance - waist circumference
Time frame: More than 1 year
Change in waist circumference
Overweight/obesity incidence
Time frame: More than 1 year
Risk ratio of Overweight/obesity incidence
Metabolic syndrome incidence
Time frame: More than 1 year
Risk ratio of metabolic syndrome incidence
Type 2 diabetes incidence
Time frame: More than 1 year
Risk ratio of type 2 diabetes incidence
Cardiovascular disease incidence
Time frame: More than 1 year
Risk ratio of cardiovascular disease incidence
Cardiovascular disease mortality
Time frame: More than 1 year
Risk ratio of Cardiovascular disease mortality
Total mortality
Time frame: More than 1 year
Risk ratio of total mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 31092156Khan TA, Malik VS, Sievenpiper JL. Letter by Khan et al Regarding Article, "Artificially Sweetened Beverages and Stroke, Coronary Heart Disease, and All-Cause Mortality in the Women's Health Initiative". Stroke. 2019 Jun;50(6):e167-e168. doi: 10.1161/STROKEAHA.119.025571. Epub 2019 May 16. No abstract available.
- Background: PubMed 30606710Malik VS. Non-sugar sweeteners and health. BMJ. 2019 Jan 3;364:k5005. doi: 10.1136/bmj.k5005. No abstract available.
- Background: PubMed 30354445Johnson RK, Lichtenstein AH, Anderson CAM, Carson JA, Despres JP, Hu FB, Kris-Etherton PM, Otten JJ, Towfighi A, Wylie-Rosett J; American Heart Association Nutrition Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Quality of Care and Outcomes Research; and Stroke Council. Low-Calorie Sweetened Beverages and Cardiometabolic Health: A Science Advisory From the American Heart Association. Circulation. 2018 Aug 28;138(9):e126-e140. doi: 10.1161/CIR.0000000000000569.
- Background: PubMed 30602577Toews I, Lohner S, Kullenberg de Gaudry D, Sommer H, Meerpohl JJ. Association between intake of non-sugar sweeteners and health outcomes: systematic review and meta-analyses of randomised and non-randomised controlled trials and observational studies. BMJ. 2019 Jan 2;364:k4718. doi: 10.1136/bmj.k4718.
- Background: PubMed 28716847Azad MB, Abou-Setta AM, Chauhan BF, Rabbani R, Lys J, Copstein L, Mann A, Jeyaraman MM, Reid AE, Fiander M, MacKay DS, McGavock J, Wicklow B, Zarychanski R. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies. CMAJ. 2017 Jul 17;189(28):E929-E939. doi: 10.1503/cmaj.161390.
- Background: PubMed 30303968Imamura F, Fretts A, Marklund M, Ardisson Korat AV, Yang WS, Lankinen M, Qureshi W, Helmer C, Chen TA, Wong K, Bassett JK, Murphy R, Tintle N, Yu CI, Brouwer IA, Chien KL, Frazier-Wood AC, Del Gobbo LC, Djousse L, Geleijnse JM, Giles GG, de Goede J, Gudnason V, Harris WS, Hodge A, Hu F; InterAct Consortium; Koulman A, Laakso M, Lind L, Lin HJ, McKnight B, Rajaobelina K, Riserus U, Robinson JG, Samieri C, Siscovick DS, Soedamah-Muthu SS, Sotoodehnia N, Sun Q, Tsai MY, Uusitupa M, Wagenknecht LE, Wareham NJ, Wu JH, Micha R, Forouhi NG, Lemaitre RN, Mozaffarian D; Fatty Acids and Outcomes Research Consortium (FORCE). Fatty acid biomarkers of dairy fat consumption and incidence of type 2 diabetes: A pooled analysis of prospective cohort studies. PLoS Med. 2018 Oct 10;15(10):e1002670. doi: 10.1371/journal.pmed.1002670. eCollection 2018 Oct.
- Background: PubMed 26365102Rogers PJ, Hogenkamp PS, de Graaf C, Higgs S, Lluch A, Ness AR, Penfold C, Perry R, Putz P, Yeomans MR, Mela DJ. Does low-energy sweetener consumption affect energy intake and body weight? A systematic review, including meta-analyses, of the evidence from human and animal studies. Int J Obes (Lond). 2016 Mar;40(3):381-94. doi: 10.1038/ijo.2015.177. Epub 2015 Sep 14.
- Derived from this study: PubMed 35901272Lee JJ, Khan TA, McGlynn N, Malik VS, Hill JO, Leiter LA, Jeppesen PB, Rahelic D, Kahleova H, Salas-Salvado J, Kendall CWC, Sievenpiper JL. Relation of Change or Substitution of Low- and No-Calorie Sweetened Beverages With Cardiometabolic Outcomes: A Systematic Review and Meta-analysis of Prospective Cohort Studies. Diabetes Care. 2022 Aug 1;45(8):1917-1930. doi: 10.2337/dc21-2130.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John L Sievenpiper, MD,PhD,FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity and Metabolic Syndrome, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global measures of adiposity with established clinical relevance - body weight (time frame: More than 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04245826, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.