Rationale, Design and Participants Baseline Characteristics of a Crossover Randomized Controlled Trial of the Effect of Replacing SSBs with NSBs versus Water on Glucose Tolerance, Gut Microbiome and Cardiometabolic Risk in Overweight or Obese Adult SSB Consumer: Strategies to Oppose SUGARS with Non-Nutritive Sweeteners or Water (STOP Sugars NOW) Trial and Ectopic Fat Sub-Study

被引：6

作者：

Ayoub-Charette, Sabrina ^{[1
,2
,3
]}

McGlynn, Nema D. ^{[1
,2
,3
]}

Lee, Danielle ^{[1
,2
,3
]}

Khan, Tauseef Ahmad ^{[1
,2
,3
]}

Mejia, Sonia Blanco ^{[1
,2
,3
]}

Chiavaroli, Laura ^{[1
,2
,3
]}

Kavanagh, Meaghan E. ^{[1
,2
,3
]}

Seider, Maxine ^{[3
]}

Taibi, Amel ^{[1
]}

Chen, Chuck T. ^{[1
]}

Ahmed, Amna ^{[1
,2
]}

Asbury, Rachel ^{[4
,5
]}

Erlich, Madeline ^{[1
,2
,5
]}

Chen, Yue-Tong ^{[1
]}

Malik, Vasanti S. ^{[1
,6
]}

Bazinet, Richard P. ^{[1
]}

Ramdath, D. Dan ^{[7
,8
]}

Logue, Caomhan ^{[9
]}

Hanley, Anthony J. ^{[1
,10
,11
]}

Kendall, Cyril W. C. ^{[1
,2
,8
]}

Leiter, Lawrence A. ^{[1
,2
,12
,13
,14
]}

Comelli, Elena M. ^{[1
]}

Sievenpiper, John L. ^{[1
,2
,3
,12
,13
,14
]}

机构：

[1] Univ Toronto, Temerty Fac Med, Dept Nutr Sci, Toronto, ON M5S 1A8, Canada

[2] St Michaels Hosp, Clin Nutr & Risk Factor Modificat Ctr, Toronto Knowledge Synth & Clin Trials Unit 3D, Toronto, ON M5C 2T2, Canada

[3] Sunnybrook Hlth Sci Ctr, Toronto, ON M4N 3M5, Canada

[4] Univ Toronto, Fac Appl Sci & Engn, Dept Chem Engn & Appl Chem, Toronto, ON M5S 3E5, Canada

[5] Coll Dietitians Ontario, Toronto, ON M2M 4J1, Canada

[6] Harvard TH Chan Sch Publ Hlth, Dept Nutr, Boston, MA 02115 USA

[7] Govt Canada, Guelph Res & Dev Ctr, Agr & Agrifood Canada, Sci & Technol Branch, Guelph, ON N1G 5C9, Canada

[8] Univ Saskatchewan, Coll Pharm & Nutr, Saskatoon, SK S7N 5E5, Canada

[9] Ulster Univ, Nutr Innovat Ctr Food & Hlth NICHE, Sch Biomed Sci, Co Londonderry, Coleraine BT52 1SA, North Ireland

[10] Univ Toronto, Dalla Lana Sch Publ Hlth, Div Endocrinol & Metab, Toronto, ON M5T 3M7, Canada

[11] Mt Sinai Hosp, Leadership Sinai Ctr Diabet, Toronto, ON M5G 1X5, Canada

[12] St Michaels Hosp, Dept Med, Div Endocrinol & Metab, Toronto, ON M5C 2T2, Canada

[13] Univ Toronto, Temerty Fac Med, Dept Med, Toronto, ON M5S 1A8, Canada

[14] St Michaels Hosp, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1T8, Canada

来源：

NUTRIENTS | 2023年 / 15卷 / 05期

基金：

加拿大健康研究院; 加拿大创新基金会;

关键词：

low- and no-calorie sweeteners; sweetening agents; sugar-sweetened beverages; water; randomized controlled trial; type; 2; diabetes; gut microbiota; glycemia; glucose control; overweight; FALSE DISCOVERY RATE; INSULIN-RESISTANCE; BEVERAGE CONSUMPTION; DIABETES-MELLITUS; PLASMA-GLUCOSE; HYPERTENSION; METAANALYSIS; HEALTH; SENSITIVITY; GUIDELINES;

D O I：

10.3390/nu15051238

中图分类号：

R15 [营养卫生、食品卫生]; TS201 [基础科学];

学科分类号：

100403 ;

摘要：

Background: Health authorities are near universal in their recommendation to replace sugar-sweetened beverages (SSBs) with water. Non-nutritive sweetened beverages (NSBs) are not as widely recommended as a replacement strategy due to a lack of established benefits and concerns they may induce glucose intolerance through changes in the gut microbiome. The STOP Sugars NOW trial aims to assess the effect of the substitution of NSBs (the "intended substitution") versus water (the "standard of care substitution") for SSBs on glucose tolerance and microbiota diversity. Design and Methods: The STOP Sugars NOW trial (NCT03543644) is a pragmatic, "head-to-head", open-label, crossover, randomized controlled trial conducted in an outpatient setting. Participants were overweight or obese adults with a high waist circumference who regularly consumed >= 1 SSBs daily. Each participant completed three 4-week treatment phases (usual SSBs, matched NSBs, or water) in random order, which were separated by >= 4-week washout. Blocked randomization was performed centrally by computer with allocation concealment. Outcome assessment was blinded; however, blinding of participants and trial personnel was not possible. The two primary outcomes are oral glucose tolerance (incremental area under the curve) and gut microbiota beta-diversity (weighted UniFrac distance). Secondary outcomes include related markers of adiposity and glucose and insulin regulation. Adherence was assessed by objective biomarkers of added sugars and non-nutritive sweeteners and self-report intake. A subset of participants was included in an Ectopic Fat sub-study in which the primary outcome is intrahepatocellular lipid (IHCL) by 1H-MRS. Analyses will be according to the intention to treat principle. Baseline results: Recruitment began on 1 June 2018, and the last participant completed the trial on 15 October 2020. We screened 1086 participants, of whom 80 were enrolled and randomized in the main trial and 32 of these were enrolled and randomized in the Ectopic Fat sub-study. The participants were predominantly middle-aged (mean age 41.8 +/- SD 13.0 y) and had obesity (BMI of 33.7 +/- 6.8 kg/m(2)) with a near equal ratio of female: male (51%:49%). The average baseline SSB intake was 1.9 servings/day. SSBs were replaced with matched NSB brands, sweetened with either a blend of aspartame and acesulfame-potassium (95%) or sucralose (5%). Conclusions: Baseline characteristics for both the main and Ectopic Fat sub-study meet our inclusion criteria and represent a group with overweight or obesity, with characteristics putting them at risk for type 2 diabetes. Findings will be published in peer-reviewed open-access medical journals and provide high-level evidence to inform clinical practice guidelines and public health policy for the use NSBs in sugars reduction strategies. Trial registration: ClinicalTrials.gov identifier, NCT03543644.

引用

页数：25