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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Canadian Diabetes Association

Information provided by (Responsible Party):

St. Michael's Hospital, Toronto

ClinicalTrials.gov Identifier:

NCT01403571

First received: July 25, 2011

Last updated: May 22, 2013

Last verified: May 2013

History of Changes

Purpose

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 the first phase 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 objective of the second phase (weight maintenance) is to assess whether any weight loss advantage attributed to Salba supplementation can be maintained for an additional six months. In the weight maintenance phase, subjects will continue their assigned supplements and follow a diet similar to the weight loss diet, but with appropriate energy levels to maintain weight.

The study will recruit 132 overweight or obese individuals with type 2 diabetes. They will be instructed to follow a calorie restricted diet and their regular diabetes therapy together with regular exercise. Participants will be 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 and insulin levels) will be assessed. In addition, related outcomes such as low-grade body inflammation, hunger-regulating hormones and satiety scores will be 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.

Condition	Intervention	Phase
Diabetes Mellitus Overweight Obesity	Dietary Supplement: Salba (Salvia hispanica L.)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss and Maintenance in Overweight and Obese Individuals With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Weight Control

Drug Information available for: Salvia

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

Weight [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body composition [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Blood sugar control [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	132
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Approximately 30g/day over 48 weeks

Eligibility


Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403571

Locations


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

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Canadian Diabetes Association

More Information

No publications provided


Responsible Party:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01403571 History of Changes
Other Study ID Numbers:	2103038AJ
Study First Received:	July 25, 2011
Last Updated:	May 22, 2013
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:


Diabetes Mellitus Overweight Body Weight Endocrine System Diseases	Glucose Metabolism Disorders Metabolic Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on March 02, 2015

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