Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Men and women in good health
* Soft drinks consumers (between 4 cans/week to 4 cans/day)

Exclusion Criteria:

* Metabolic disorders (hypertension, diabetes, hypercholesterolemia)
* Daily consumption of more than 4 cans of soft drinks
* Regular use of medication affecting study parameters
* Change of medication (type or dose) in the last year
* Use of antibiotics in the last 3 months
* Change in natural health product use in the last 3 months
* More than 2 alcohol drinks par day
* Weight change of more than 5% in the last 3 months
* Surgery in the last 3 months or planed during the study
* Allergy or intolerance for products contained in soft drinks
B: Inclusion Criteria:

* BMI between 25 kg /m² to 36 kg / m², with low intensity physical activities and consumers of at least 3 portions of artificially sweetened beverages per week

Exclusion Criteria:

* students with hyper or hypothyroidism, pregnant women and those who perform high to moderate physical activities
C: Inclusion Criteria:

* Female
* BMI 30-35 kg/m²
* at least one period of dietary restriction of 4 weeks or more in the last 24 months

Exclusion Criteria:

* dislike of popular sweet carbonated drinks
* dieting during the last month
* history of diabetes
* having an eating disorder
* depression,
* being a smoker
* pregnant
* lactating,
* wearing a pacemaker
* currently taking medication for mood or thyroid disorders
D: A) Inclusion Criteria:

Eligible participants will be:

1. men, over 50
2. postmenopausal women, over 60 or
3. postmenopausal women under 60 with a family history of hypercholesterolemia and 1 CVD risk factor.

Participants will have the following characteristics:

* BMI 25-40 kg/m2 with body weight that has remained constant (within ±3%) over the last 3 months preceding the onset of the study
* Plus at least 1 of the following 3 criteria:

  1. have type 2 diabetes with one of the following:

     * raised LDL-C(in accordance with the 2012 Canadian Cardiovascular Society Guidelines)
     * raised BP (\> 130/80mmHg), or
     * active smoking;
  2. be non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy; and
  3. have a modified Framingham risk score \>20% (CCS 2012) and are unable (intolerant) or unwilling to take statin drugs.

B) Exclusion Criteria:

Individuals with the following conditions will be excluded:

* cardiovascular disease that precludes exercise e.g.

  * recent stroke or
  * myocardial infarction, or
* cardiac condition that compromises normal function

  * mitral valve disease,
  * heart failure--grades 2-4 (New York Heart Association classification),
  * severe angina or
  * other conditions preventing exercise,
* secondary causes of hypercholesterolemia

  * hypothyroidism, (unless treated and on a stable dose of L-thyroxine)
  * renal or liver disease
* uncontrolled blood pressure
* major disability
* disorder requiring continuous medical attention and treatment:

  * chronic heart failure,
  * liver disease,
  * renal failure or
  * cancer (except non-melanoma skin cancer--basal cell, squamous cell),
* chronic infections (bacterial or viral)
* chronic inflammatory diseases (e.g. lupus, ulcerative colitis)
* other autoimmune diseases
* major surgery \<6 months prior to randomization
* alcohol consumption \>2 drinks/d.

Answer: A