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

NCT ID: NCT01403571

Last Updated: 2016-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-08-31

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 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.

Conditions

Diabetes Mellitus; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Salba supplement

30g/1000kal

Group Type: EXPERIMENTAL

Salba (Salvia hispanica L.)

Intervention Type: DIETARY_SUPPLEMENT

30g/1000kcal/day over 24 wks

Oat-bran based Control Supplement

36g/1000kcal

Group Type: PLACEBO_COMPARATOR

Oat-based Control

Intervention Type: DIETARY_SUPPLEMENT

Placebo: 36g/1000kcal/day over 24 weeks

Interventions

Salba (Salvia hispanica L.)

30g/1000kcal/day over 24 wks

Intervention Type: DIETARY_SUPPLEMENT

Oat-based Control

Placebo: 36g/1000kcal/day over 24 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Diabetes Association

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Risk Factor Modification Centre, St. Michael's

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28089080 (View on PubMed)

Other Identifiers

2103038AJ

Identifier Type: -

Identifier Source: org_study_id