The Effects of Salvia Hispanica-Enriched Foods on Glycemic and Insulinemic Responses and Subjective Satiety

February 17, 2009 updated by: Unity Health Toronto
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).

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Clinical Nutrition and Risk Factor Modification Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 20-35 kg/m2

Exclusion Criteria:

  • Endocrine disease (adrenal disorders, glucose homeostasis disorders, metabolic bone diseases, pituitary gland disorders, parathyroid gland disorders, thyroid disorders)
  • Pregnancy
  • Use of drugs that influence carbohydrate metabolism (e.g. systemic glucocorticoids, beta blockers, thiazide diuretics)
  • Use of fiber supplements
  • Substance abuse (including regular smoking)
  • Digestive or malabsorption disorders (malabsorption syndrome, Crohn's disease, stomach ulcer, duodenal ulcer or intestinal parasites)
  • Presence of any significant disease or condition, including emotional or psychiatric disorders, that, in the opinion of the investigator, is likely to alter the metabolic state or interfere with the subject's ability to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
White Bread (control)
About 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water
Experimental: 2
White Bread (control)
About 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water
Experimental: 3
White bread with 7.32 grams Salba hispanica
About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
Experimental: 4
White bread with 15.58 grams Salba hispanica
About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
Experimental: 5
White bread with 24 grams Salba hispanica
About 100g of white bread consisting of 50g of available carbohydrates and 24g Salvia hispanica, served with 250mL water
Experimental: 6
Rice Milk (control)
Rice milk containing 50g of available carbohydrates
Experimental: 7
Rice Milk (control)
Rice milk containing 50g of available carbohydrates
Experimental: 8
Rice Milk with 7.32 grams Salba hispanica
Rice milk containing 50g of available carbohydrates with 7.32g added Salvia hispanica
Experimental: 9
Rice Milk with 15.58 grams Salba hispanica
Rice milk containing 50g of available carbohydrates with 15.58g added Salvia hispanica
Experimental: 10
Rice Milk with 24 grams Salba hispanica
Rice milk containing 50g of available carbohydrates with 24g added Salvia hispanica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post prandial capillary blood glucose levels
Time Frame: 2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour
2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient completed satiety questionnaire
Time Frame: 2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour
2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 1, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimate)

August 5, 2008

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 07-121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Prandial Blood Glucose

Clinical Trials on White Bread

3
Subscribe