Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Controlled Trial of the Effect of Replacing Sugar-sweetened Beverages With Non-nutritive Sweetened Beverages or Water on Gut Microbiome and Metabolic Outcomes: STOP Sugars NOW Trial
Brief Summary: Health authorities recommend a reduction in added sugars from sugar-sweetened beverages (SSBs) due to risk of obesity and diabetes. As a sugar-reduction strategy, finding the ideal SSB replacement is of the utmost importance. Those who are already consuming SSBs might not easily replace it with water and therefore non-nutritive sweetened beverages (NSBs) present a sweetened alternative, though guidelines recommend water instead of NSBs as a replacement for SSBs. Recent evidence suggests that saccharine, a non-nutritive sweetener, which is not found in NSBs, might induce glucose intolerance by altering gut microbiota in humans. It is currently not known if replacing SSBs with NSBs (which contain low-calorie sweeteners other than saccharine) or water will have any effect on the human gut microbiota and any downstream diabetic risk. The investigators plan to undertake a randomized controlled cross-over trial in 75 healthy adults to assess the effect of replacing SSBs with equal amounts of NSBs or water for 4 weeks on the composition and diversity of human gut microbiota, changes in glucose tolerance and total body fat in those who regularly drink SSBs. Each participant will act as their own control receiving each of the three interventions of SSB, NSB and water for four weeks in random order, each period separated by a four-week wash-out period. All study visits will occur at the Clinical Nutrition and Risk Factor Modification Centre at St. Michael's Hospital. This study will contribute to knowledge that will inform dietary guidelines and public policy with regards to the best possible replacement for SSBs. It will also shed light on the potential mechanism of the adverse effects of NSBs and if the replacement of SSBs by NSBs or water are in fact similar with respect to their effect on gut bacteria and any downstream diabetic risk.


Options:
A: Arm Label: Fructose 9%; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Dietary Compliance | Arm Label: Glucose 9%; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Dietary Compliance | Arm Label: High fructose corn syrup 18%; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Dietary Compliance | Arm Label: Sucrose 18%; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Dietary Compliance | Intervention Type: BEHAVIORAL; Name: Dietary Compliance; Assigned to Arm(s): Fructose 9%, Glucose 9%, High fructose corn syrup 18%, Sucrose 18%
B: Arm Label: HFCS-EB; Type: EXPERIMENTAL; Interventions: Other: high fructose corn syrup, Other: Energy-balanced diet | Arm Label: Asp-EB; Type: PLACEBO_COMPARATOR; Interventions: Other: aspartame, Other: Energy-balanced diet | Arm Label: HFCS-AL; Type: EXPERIMENTAL; Interventions: Other: high fructose corn syrup, Other: Ad libitum diet | Arm Label: Asp-AL; Type: PLACEBO_COMPARATOR; Interventions: Other: aspartame, Other: Ad libitum diet | Intervention Type: OTHER; Name: high fructose corn syrup; Assigned to Arm(s): HFCS-AL, HFCS-EB | Intervention Type: OTHER; Name: aspartame; Assigned to Arm(s): Asp-AL, Asp-EB | Intervention Type: OTHER; Name: Energy-balanced diet; Assigned to Arm(s): Asp-EB, HFCS-EB | Intervention Type: OTHER; Name: Ad libitum diet; Assigned to Arm(s): Asp-AL, HFCS-AL
C: Arm Label: CONTROL; Type: ACTIVE_COMPARATOR; Interventions: Other: Diet | Arm Label: LOW SUG; Type: EXPERIMENTAL; Interventions: Other: Diet | Arm Label: LOW CHO; Type: EXPERIMENTAL; Interventions: Other: Diet | Intervention Type: OTHER; Name: Diet; Assigned to Arm(s): CONTROL, LOW CHO, LOW SUG
D: Arm Label: Sugar-sweetened beverage (SSB); Type: ACTIVE_COMPARATOR; Interventions: Other: Sugar-sweetened beverage (SSB) | Arm Label: Non-nutritive sweetened beverage (NSB); Type: EXPERIMENTAL; Interventions: Other: Non-nutritive sweetened beverages (NSB) | Arm Label: Water; Type: EXPERIMENTAL; Interventions: Other: Water | Intervention Type: OTHER; Name: Sugar-sweetened beverage (SSB); Assigned to Arm(s): Sugar-sweetened beverage (SSB) | Intervention Type: OTHER; Name: Non-nutritive sweetened beverages (NSB); Assigned to Arm(s): Non-nutritive sweetened beverage (NSB) | Intervention Type: OTHER; Name: Water; Assigned to Arm(s): Water

Answer: D