Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Free Sugar Replacement with Non-nutritive Sweeteners on Metabolic Health of High Sugar Sweetened Beverages Consumers: Potential Role of the Gut Microbiome
Brief Summary: Increasing evidence suggest that artificial sweeteners such as saccharin, aspartame and sucralose may not be as metabolically safe as they first appeared, and it has been proposed that their consumption may be linked to important disturbances in the gut microbiome. Some in vitro and in vivo studies suggest that the recently approved sugar substitute Stevia (eg. steviol glycosides) can also influence intestinal homeostasis. However, it is not clear whether this natural non-nutritive sweetener (NNS) could also cause metabolic and microbiome disturbances as proposed for their synthetic counterparts. In fact, steviol glycosides may even have a beneficial impact on glucose homeostasis and lipid metabolism possibly through a positive action on intestinal health and gut microbiome, but this has yet to be experimentally tested in a rigorous study.

The main objective of this project is to evaluate whether steviol glycosides sweetened beverages (SGSB) or aspartame/acesulfame K sweetened beverages (AASB) exert beneficial, neutral or detrimental effects on metabolic health of regular consumers of sugar-sweetened beverages (SSBs), and whether modulation of the gut microbiome is involved in the resulting impact of these NNSs on metabolic health.

As chronic overconsumption of SSBs is clearly associated with an increased cardiometabolic risk, this study will be the first to determine the metabolic impact of replacing SSBs by potentially "healthier alternatives" such as the increasingly popular stevia-based soft drinks and aspartame-based soft drinks. The investigators will further investigate whether these NNS can cause pernicious effects on intestinal health and the gut microbiome. It is a crucial concern since the importance of this unsuspected key "organ" has been ignored for too long and its important implication in many chronic societal diseases has just been discovered.

Results of this study could have a direct influence on health, nutrition and even agricultural policies as well as dietary guidelines around the world. This project is also critically important as an increasing amount of health professionals such as physicians, nurses and registered dietitians seek to provide evidenced-based guidance to individuals looking for healthier alternatives to SSBs including stevia-based or aspartame-based soft drinks.


Options:
A: Arm Label: Regular beverages; Type: ACTIVE_COMPARATOR; Interventions: Other: 710 ml of regular soft drinks, taken daily for 10 weeks | Arm Label: Diet beverages; Type: EXPERIMENTAL; Interventions: Other: 710 ml of diet soft drinks, taken daily for 10 weeks | Arm Label: Stevia beverages; Type: EXPERIMENTAL; Interventions: Other: 710 ml of stevia-sweetened soft drinks, taken daily for 10 weeks | Intervention Type: OTHER; Name: 710 ml of regular soft drinks, taken daily for 10 weeks; Assigned to Arm(s): Regular beverages | Intervention Type: OTHER; Name: 710 ml of diet soft drinks, taken daily for 10 weeks; Assigned to Arm(s): Diet beverages | Intervention Type: OTHER; Name: 710 ml of stevia-sweetened soft drinks, taken daily for 10 weeks; Assigned to Arm(s): Stevia beverages
B: Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: intervention group; Type: EXPERIMENTAL; Interventions: Dietary Supplement: artificially sweetened beverages | Intervention Type: DIETARY_SUPPLEMENT; Name: artificially sweetened beverages; Assigned to Arm(s): intervention group
C: Arm Label: Sucrose; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Sucrose | Arm Label: Aspartame; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Aspartame | Intervention Type: DIETARY_SUPPLEMENT; Name: Sucrose; Assigned to Arm(s): Sucrose | Intervention Type: DIETARY_SUPPLEMENT; Name: Aspartame; Assigned to Arm(s): Aspartame
D: Arm Label: Enhanced Portfolio plus structured exercise; Type: EXPERIMENTAL; Interventions: Behavioral: Enhanced portfolio plus structured exercise | Arm Label: High fiber diet plus routine exercise; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: High fiber diet plus routine exercise | Intervention Type: BEHAVIORAL; Name: Enhanced portfolio plus structured exercise; Assigned to Arm(s): Enhanced Portfolio plus structured exercise | Intervention Type: BEHAVIORAL; Name: High fiber diet plus routine exercise; Assigned to Arm(s): High fiber diet plus routine exercise

Answer: A