An interventional study of White Bread and White bread with added 7.32g Salvia hispanica in Post Prandial Blood Glucose, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-18.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Prevention
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).
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.
Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
White Bread (control)
Dietary Supplement: White Bread
White Bread (control)
Dietary Supplement: White Bread
White bread with 7.32 grams Salba hispanica
Dietary Supplement: White bread with added 7.32g Salvia hispanica
White bread with 15.58 grams Salba hispanica
Dietary Supplement: White bread with added 15.58g Salvia hispanica
White bread with 24 grams Salba hispanica
Dietary Supplement: White bread with added Salvia hispanica
Rice Milk (control)
Dietary Supplement: Rice milk
Rice Milk (control)
Dietary Supplement: Rice milk
Rice Milk with 7.32 grams Salba hispanica
Dietary Supplement: Enriched rice milk containing 7.32g Salvia hispanica
Rice Milk with 15.58 grams Salba hispanica
Dietary Supplement: Enriched rice milk containing 15.58g Salvia hispanica
Rice Milk with 24 grams Salba hispanica
Dietary Supplement: Enriched rice milk containing 24g Salvia hispanica
About 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water
About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
About 100g of white bread consisting of 50g of available carbohydrates and 24g Salvia hispanica, served with 250mL water
Rice milk containing 50g of available carbohydrates
Rice milk containing 50g of available carbohydrates with 7.32g added Salvia hispanica
Rice milk containing 50g of available carbohydrates with 15.58g added Salvia hispanica
Rice milk containing 50g of available carbohydrates with 24g added Salvia hispanica
Post prandial capillary blood glucose levels
Time frame: 2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour
Patient completed satiety questionnaire
Time frame: 2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour
This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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