Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes

Obesity Clinical Trial

— LOSS  

Official title:

Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403571
• Other study ID #: 2103038AJ
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2011
• Last updated: October 4, 2016
• Start date: October 2009
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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 Salba/1000 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Well-controlled type 2 diabetes for at least 1 year

• Treated with diet and/or oral hypoglycemic medications

• BMI 25-40 kg/m2

Exclusion Criteria:

• Weight change in the past three months >10% of body weight

• On insulin therapy

• Unstable angina, myocardial infarction or stroke (within 6 months)

• Planned surgery or pregnancy

• Blood pressure >160mmHg/100mmHg

• Surgical procedures for weight loss and concomitant use of medication or supplements that alter body weight or appetite

• ALA, dietary fibre, fish oil supplements or consuming cold-water fish more than three times per week

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Overweight
• Weight Loss

Intervention

Dietary Supplement:
• Salba (Salvia hispanica L.)
30g/1000kcal/day over 24 wks
• Oat-based Control
Placebo: 36g/1000kcal/day over 24 weeks

Locations

Country	Name	City	State
Canada	Risk Factor Modification Centre, St. Michael's	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Diabetes Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	24 week timeframe for Weightloss phase	24 weeks	No
Secondary	Body composition	24 week timeframe for Weightloss phase	24 weeks	No
Secondary	Blood sugar control	(HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase	24 weeks	Yes
Secondary	Low grade body inflammation	hs-CRP levels	24 weeks	No
Secondary	serum ALT	Safety Measures	24 weeks	Yes
Secondary	Prothrombin time	Safety Measures	24 weeks	Yes
Secondary	serum creatinine	Safety Measures	24 weeks	Yes
Secondary	Blood urea	Safety Measures	24 weeks	Yes
Secondary	Satiety hormones	ghrelin, adiponectin	24 weeks	No
Secondary	Fatty Acids (% composition)	ALA (18:3 n-3), LA (18:2 n-6); Compliance measure	24 weeks	No