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Sponsored by: |
St. Michael's Hospital, Toronto |
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Information provided by: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT00728065 |
Salvia hispanic (Salba) is postulated to increase satiety. This study determines the optimal amount of Salba as well as whether liquid or solid enriched products will produce maximum satiety. The results can gauge the effectiveness of Salba in weight loss programs. The study has a randomized, double-blind crossover design which includes 10 test meals and capillary blood sampling to perform glucose and insulin analyses (to determine blood glucose response and blood insulin response).
Condition | Intervention |
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Post Prandial Blood Glucose |
Dietary Supplement: White Bread Dietary Supplement: White bread with added 7.32g Salvia hispanica Dietary Supplement: White bread with added 15.58g Salvia hispanica Dietary Supplement: White bread with added Salvia hispanica Dietary Supplement: Rice milk Dietary Supplement: Enriched rice milk containing 7.32g Salvia hispanica Dietary Supplement: Enriched rice milk containing 15.58g Salvia hispanica Dietary Supplement: Enriched rice milk containing 24g Salvia hispanica |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | The Effects of Salvia Hispanica-Enriched Foods on Glycemic and Insulinemic Responses and Subjective Satiety |
Estimated Enrollment: | 30 |
Study Start Date: | December 2007 |
Study Completion Date: | February 2009 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
White Bread (control)
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Dietary Supplement: White Bread
About 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water
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2: Experimental
White Bread (control)
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Dietary Supplement: White Bread
About 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water
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3: Experimental
White bread with 7.32 grams Salba hispanica
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Dietary Supplement: White bread with added 7.32g Salvia hispanica
About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
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4: Experimental
White bread with 15.58 grams Salba hispanica
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Dietary Supplement: White bread with added 15.58g Salvia hispanica
About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
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5: Experimental
White bread with 24 grams Salba hispanica
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Dietary Supplement: White bread with added Salvia hispanica
About 100g of white bread consisting of 50g of available carbohydrates and 24g Salvia hispanica, served with 250mL water
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6: Experimental
Rice Milk (control)
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Dietary Supplement: Rice milk
Rice milk containing 50g of available carbohydrates
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7: Experimental
Rice Milk (control)
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Dietary Supplement: Rice milk
Rice milk containing 50g of available carbohydrates
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8: Experimental
Rice Milk with 7.32 grams Salba hispanica
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Dietary Supplement: Enriched rice milk containing 7.32g Salvia hispanica
Rice milk containing 50g of available carbohydrates with 7.32g added Salvia hispanica
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9: Experimental
Rice Milk with 15.58 grams Salba hispanica
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Dietary Supplement: Enriched rice milk containing 15.58g Salvia hispanica
Rice milk containing 50g of available carbohydrates with 15.58g added Salvia hispanica
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10: Experimental
Rice Milk with 24 grams Salba hispanica
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Dietary Supplement: Enriched rice milk containing 24g Salvia hispanica
Rice milk containing 50g of available carbohydrates with 24g added Salvia hispanica
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There are many factors that are involved in the ability of foods to suppress appetite, for instance the fiber, fat and protein contents of the food. The novel whole grain Salvia hispanica may significantly lower appetite compared to refined carbohydrates and other whole grains because of its composition. First, Salvia hispanica's high fiber content may help lower postprandial glycemia. Whole grains are much higher in fiber than refined carbohydrates. High fiber foods are thought to be more satiating because they have lower energy densities and delay gastric emptying, causing glucose to be released more slowly into the circulation. This, in turn, is hypothesized to increase satiety by preventing a sudden drop in blood glucose levels, which would normally trigger hunger . Another mechanism by which fiber may promote satiety, independent of glycemic responses, is through the secretion of gut hormones that signal fullness . Furthermore, Salvia hispanica may be more satiating than other whole grains due to its higher fat and protein contents. Protein and fat also prolong satiety due to mechanisms such as delayed gastric emptying and secretion of gut hormones .
Results from preliminary studies confirm the satiating effects of Salvia hispanica, as they demonstrate that this grain induces increased subjective satiety and reduced postprandial glycemia. It is presumed that if a food is satiating, it will decrease subsequent intake of other foods because hunger is suppressed. A lower caloric intake, in turn, would help promote weight loss.
Salvia hispanica may also encourage weight loss via another mechanism. Preliminary studies suggested that this grain has a lower glycemic index value than white flour. Consumption of low-GI foods compared to high-GI foods has been suggested to reduce obesity by discouraging fat deposition and promoting fat oxidation . Thus, Salvia hispanica could potentially promote weight loss by reducing both hunger and the amount of body fat stored.
In order to study Salvia hispanica's ability to promote weight loss, feasibility studies must first be done to determine what amount is optimal for satiety and also whether enriched products are most satiating in liquid or solid form.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Clinical Nutrition and Risk Factor Modification Centre ( Dr. Vladimir Vuksan ) |
Study ID Numbers: | 07-121 |
Study First Received: | August 1, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00728065 History of Changes |
Health Authority: | Canada: Health Canada |