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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus; Overweight
• Intervention / Treatment: Dietary supplement: Salba (Salvia hispanica L.); Dietary supplement: Oat-based Control

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B1W8
      • Risk Factor Modification Centre, St. Michael's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salba supplement; 30g/1000kal	Dietary supplement: Salba (Salvia hispanica L.); 30g/1000kcal/day over 24 wks
Placebo Comparator: Oat-bran based Control Supplement; 36g/1000kcal	Dietary supplement: Oat-based Control; Placebo: 36g/1000kcal/day over 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	24 week timeframe for Weightloss phase	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	24 week timeframe for Weightloss phase	24 weeks
Blood sugar control	(HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase	24 weeks
Low grade body inflammation	hs-CRP levels	24 weeks
serum ALT	Safety Measures	24 weeks
Prothrombin time	Safety Measures	24 weeks
serum creatinine	Safety Measures	24 weeks
Blood urea	Safety Measures	24 weeks
Satiety hormones	ghrelin, adiponectin	24 weeks
Fatty Acids (% composition)	ALA (18:3 n-3), LA (18:2 n-6); Compliance measure	24 weeks

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Canadian Diabetes Association

Publications and helpful links

General Publications

• Vuksan V, Jenkins AL, Brissette C, Choleva L, Jovanovski E, Gibbs AL, Bazinet RP, Au-Yeung F, Zurbau A, Ho HV, Duvnjak L, Sievenpiper JL, Josse RG, Hanna A. Salba-chia (Salvia hispanica L.) in the treatment of overweight and obese patients with type 2 diabetes: A double-blind randomized controlled trial. Nutr Metab Cardiovasc Dis. 2017 Feb;27(2):138-146. doi: 10.1016/j.numecd.2016.11.124. Epub 2016 Dec 9.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Body Weight Changes; Diabetes Mellitus; Weight Loss; Overweight
• Other Study ID Numbers: 2103038AJ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No