This trial is evaluating whether Saskatoon berry will improve 2 primary outcomes, 6 secondary outcomes, and 1 other outcome in patients with Metabolic Diseases. Measurement will happen over the course of Onset, 5 and 10 weeks after the start of dietary intervention.
This trial requires 20 total participants across 2 different treatment groups
This trial involves 2 different treatments. Saskatoon Berry is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Metabolic diseases include obesity, type 2 diabetes, and cardiovascular diseases like hypertension and heart failure. A number of conditions result in abnormalities in the body's cellular metabolism. The effects of this can be seen in both the body's size and weight, and also in its structure and function, leading to increased risk for disease. There is growing awareness of the importance of optimizing the body's nutrient metabolism and the benefits of a dietary pattern rich in whole grains and vegetables.\n
Atherosclerosis is a frequent cause of angina, heart attacks and stroke in people with diabetes or high blood pressure. Obesity can increase the risk of developing metabolic disorders such as type 2 diabetes, hypertension or coronary heart disease.
The current body of evidence suggests that obesity can be treated, but there is no conclusive evidence that it can be cured. Obesity is a long-term and chronic disease which is not cured by treatment and monitoring in the short term. The benefits will depend on the person being treated and if sufficient intervention and monitoring occurs, weight loss is likely to occur.
While the National Institutes of Health defines metabolic disease as one or more of 9 broad categories (hyperinsulinemia/hyperglycemia, obesity, adiponectin deficiency, fatty liver, insulin resistance, dyslipidemia, nonalcoholic fatty liver disease, gestational diabetes, and T2DM), the World Health Organization (WHO) defines metabolic syndrome as a clustering of the above-mentioned conditions, but does not use specific numbers in its criteria. Based on these definitions and criteria and estimates, the numbers of the US population with each type of disorder vary widely: the largest estimates are hyperinsulinemia/hyperglycemia and hyperinsulinemia/hyperlipidemia to 1.
The first drug line is often initiated with metformin, a medication originally developed for type 2 diabetes, for which the benefits outweigh its risks. New research studies with metformin have questioned its efficacy for type 2 diabetes. In adults, other alternatives typically initiate with oral clonazepam, with or without a subsequent dose of metformin. Clonazepam, an GABA receptor antagonist/anticonvulsant, may benefit with type 2 diabetes, but there is some concern of CNS effects from long-term use. The antidepressant bupropion, or Wellbutrin, used to treat major depressive disorder and generalized anxiety disorder, is commonly used for obese adolescents.
A wide range of clinical manifestations, e.g. diabetes, hypogylcaemia, hypertension, hyperglycaemia, hypertriglyceridaemia and hypolipidaemia are associated with metabolic abnormalities and their signs also appear frequently in patients with metabolic diseases. Hence they may represent clinical manifestations rather than signs of metabolic abnormalities in patients with metabolic diseases.
Saskatoon berries are sold in some health food stores in Canada. However, more research is required to determine the safety of consuming saskatoon berries, especially those that were processed. The following conditions may occur during the consumption of saskatoon berries that can lead to illness: vomiting, diarrhea, loss of appetite, dehydration, nausea and dizziness. However, all patients who eat saskatoon berries are advised to eat a diet of a healthy balanced diet to keep themselves well.
Based on these results, it appears that Saskatoon berry does reduce body weight and improves other secondary end points. Subjects taking the berry experienced significantly less abdominal discomfort and adverse side effects during the treatment period compared to participants taking a placebo. However, as the dosage was low in this study, further, larger-scale trials are now needed.
The ingestion of Saskatoon berries significantly improved quality of life, especially for dysregulated metabolism. Results from a recent paper suggest that Saskatoon berries can be a viable nonpharmacologic therapeutic alternative in the treatment of those with metabolic diseases.
The scientific interest in Saskatoon berry increased markedly in the last decades, although no studies have reported the use of saskatoon berry for the treatment of human diseases. Therefore, the development of effective products using the medicinal qualities of s Saskatoon berry are still to be found.
Some side effects do emerge in patients, which are more commonly associated with pharmacologically active constituents of SBF. These side effects can be attributed to the natural herbal contents and are not related to the pharmacologically active constituents.
The main conclusion was that there is very little clinical evidence available of what is recommended in saskatoon berry usage. The recommended dosage was much higher than the accepted dosage and therefore many patients might not have been treated properly. The study highlights the need for a well-designed randomized controlled trial, as saskatoon berry treatment of metabolic diseases is not validated and the therapy is not widely used.