Ignite Creation Date:
2024-05-05 @ 11:45 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01403571
Status:
COMPLETED
Last Update Posted:
2016-10-05
First Post:
2011-07-25
Brief Title:
Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Efficacy and Safety of Whole Grain Salba Salvia Hispanica L on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOSS
Brief Summary:
Canadian statistics indicate that the incidence of obesity is increasing and that the occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy weight making weight control in this population particularly relevant Preliminary clinical data has shown that the whole grain Salba may improve type 2 diabetes control reduce after-meal blood glucose cardiovascular disease CVD risk factors and suppress appetite Its use may therefore have potential implications in long-term weight management while improving diabetes
The objective of this research weight loss is to evaluate whether adding Salba to an energy reduced diet for six months will result in greater weight loss compared to control in overweight and obese individuals with type 2 diabetes The study recruited 77 overweight or obese individuals with type 2 diabetes They were instructed to follow a calorie restricted diet and their regular diabetes therapy together with regular exercise Participants were randomly assigned to receive 30 g Salba1000 kcal of daily energy requirements or an oat bran control supplement matched for energy The effect of the supplements on weight-loss including waist circumference body fat and glucose control A1c fasting glucose levels will be assessed In addition related outcomes such as low-grade body inflammation hunger-regulating hormones ghrelin adiponectin safety measures urea creatinine ALT and prothrombin time and satiety scores were evaluated
Modest weight loss has been associated with improved glucose control in individuals with type 2 diabetes Addition of Salba to an energy reduced diet may facilitate greater weight loss and improve glycemic control and CVD risk factors compared to such a diet alone Salba may also promote maintenance of weight loss and therefore help prevent weight gain by providing feelings of fullness that reduce appetite In light of the high incidence of obesity in individuals with diabetes Salba grain may be a useful addition to the diet
The objective of this research weight loss is to evaluate whether adding Salba to an energy reduced diet for six months will result in greater weight loss compared to control in overweight and obese individuals with type 2 diabetes The study recruited 77 overweight or obese individuals with type 2 diabetes They were instructed to follow a calorie restricted diet and their regular diabetes therapy together with regular exercise Participants were randomly assigned to receive 30 g Salba1000 kcal of daily energy requirements or an oat bran control supplement matched for energy The effect of the supplements on weight-loss including waist circumference body fat and glucose control A1c fasting glucose levels will be assessed In addition related outcomes such as low-grade body inflammation hunger-regulating hormones ghrelin adiponectin safety measures urea creatinine ALT and prothrombin time and satiety scores were evaluated
Modest weight loss has been associated with improved glucose control in individuals with type 2 diabetes Addition of Salba to an energy reduced diet may facilitate greater weight loss and improve glycemic control and CVD risk factors compared to such a diet alone Salba may also promote maintenance of weight loss and therefore help prevent weight gain by providing feelings of fullness that reduce appetite In light of the high incidence of obesity in individuals with diabetes Salba grain may be a useful addition to the diet
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None