Post Prandial Blood GlucoseNCT00728065
The Effects of Salvia Hispanica-Enriched Foods on Glycemic and Insulinemic Responses and Subjective Satiety
A study testing White Bread, White bread with added 7.32g Salvia hispanica and White bread with added 15.58g Salvia hispanica in people with Post Prandial Blood Glucose, run by Unity Health Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Prandial Blood Glucose
- What is being tested?
- White Bread, White bread with added 7.32g Salvia hispanica and White bread with added 15.58g Salvia hispanica
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 20-35 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, M5C 2T2
About this study
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).
Read the 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.
- Conditions
- Post Prandial Blood Glucose
- Being tested
- White Bread, White bread with added 7.32g Salvia hispanica, White bread with added 15.58g Salvia hispanica, White bread with added Salvia hispanica, Rice milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White BreadDietary supplement
About 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water
White bread with added 7.32g Salvia hispanicaDietary supplement
About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
White bread with added 15.58g Salvia hispanicaDietary supplement
About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
White bread with added Salvia hispanicaDietary supplement
About 100g of white bread consisting of 50g of available carbohydrates and 24g Salvia hispanica, served with 250mL water
Rice milkDietary supplement
Rice milk containing 50g of available carbohydrates
Enriched rice milk containing 7.32g Salvia hispanicaDietary supplement
Rice milk containing 50g of available carbohydrates with 7.32g added Salvia hispanica
Enriched rice milk containing 15.58g Salvia hispanicaDietary supplement
Rice milk containing 50g of available carbohydrates with 15.58g added Salvia hispanica
Enriched rice milk containing 24g Salvia hispanicaDietary supplement
Rice milk containing 50g of available carbohydrates with 24g added Salvia hispanica
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | White Bread (control) Receives: Dietary Supplement: White Bread |
| 2 | Experimental | White Bread (control) Receives: Dietary Supplement: White Bread |
| 3 | Experimental | White bread with 7.32 grams Salba hispanica Receives: Dietary Supplement: White bread with added 7.32g Salvia hispanica |
| 4 | Experimental | White bread with 15.58 grams Salba hispanica Receives: Dietary Supplement: White bread with added 15.58g Salvia hispanica |
| 5 | Experimental | White bread with 24 grams Salba hispanica Receives: Dietary Supplement: White bread with added Salvia hispanica |
| 6 | Experimental | Rice Milk (control) Receives: Dietary Supplement: Rice milk |
| 7 | Experimental | Rice Milk (control) Receives: Dietary Supplement: Rice milk |
| 8 | Experimental | Rice Milk with 7.32 grams Salba hispanica Receives: Dietary Supplement: Enriched rice milk containing 7.32g Salvia hispanica |
| 9 | Experimental | Rice Milk with 15.58 grams Salba hispanica Receives: Dietary Supplement: Enriched rice milk containing 15.58g Salvia hispanica |
| 10 | Experimental | Rice Milk with 24 grams Salba hispanica Receives: Dietary Supplement: Enriched rice milk containing 24g Salvia hispanica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post prandial capillary blood glucose levels
Measured: 2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour
Secondary outcomes (1)
Patient completed satiety questionnaire
Measured: 2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Prandial Blood GlucoseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728065
- Sponsor's protocol ID
- 07-121
- Status last verified
- Feb 2009
- First submitted
- 1 Aug 2008
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Salvia Hispanica-Enriched Foods on Glycemic and Insulinemic Responses and Subjective Satiety
- ClinicalTrials.gov ID
- NCT00728065
- Acronym / sponsor ID
- 07-121
- Conditions
- Post Prandial Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: White BreadWhite Bread (control) |
| 2 | Experimental | Dietary Supplement: White BreadWhite Bread (control) |
| 3 | Experimental | Dietary Supplement: White bread with added 7.32g Salvia hispanicaWhite bread with 7.32 grams Salba hispanica |
| 4 | Experimental | Dietary Supplement: White bread with added 15.58g Salvia hispanicaWhite bread with 15.58 grams Salba hispanica |
| 5 | Experimental | Dietary Supplement: White bread with added Salvia hispanicaWhite bread with 24 grams Salba hispanica |
| 6 | Experimental | Dietary Supplement: Rice milkRice Milk (control) |
| 7 | Experimental | Dietary Supplement: Rice milkRice Milk (control) |
| 8 | Experimental | Dietary Supplement: Enriched rice milk containing 7.32g Salvia hispanicaRice Milk with 7.32 grams Salba hispanica |
| 9 | Experimental | Dietary Supplement: Enriched rice milk containing 15.58g Salvia hispanicaRice Milk with 15.58 grams Salba hispanica |
| 10 | Experimental | Dietary Supplement: Enriched rice milk containing 24g Salvia hispanicaRice Milk with 24 grams Salba hispanica |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 20-35 kg/m2
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White BreadAbout 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water | Dietary supplement | 1, 2 |
| White bread with added 7.32g Salvia hispanicaAbout 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water | Dietary supplement | 3 |
| White bread with added 15.58g Salvia hispanicaAbout 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water | Dietary supplement | 4 |
| White bread with added Salvia hispanicaAbout 100g of white bread consisting of 50g of available carbohydrates and 24g Salvia hispanica, served with 250mL water | Dietary supplement | 5 |
| Rice milkRice milk containing 50g of available carbohydrates | Dietary supplement | 6, 7 |
| Enriched rice milk containing 7.32g Salvia hispanicaRice milk containing 50g of available carbohydrates with 7.32g added Salvia hispanica | Dietary supplement | 8 |
| Enriched rice milk containing 15.58g Salvia hispanicaRice milk containing 50g of available carbohydrates with 15.58g added Salvia hispanica | Dietary supplement | 9 |
| Enriched rice milk containing 24g Salvia hispanicaRice milk containing 50g of available carbohydrates with 24g added Salvia hispanica | Dietary supplement | 10 |
Primary outcome
Post prandial capillary blood glucose levels
Time frame: 2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour
1 secondary outcome
Patient completed satiety questionnaire
Time frame: 2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Bread, White bread with added 7.32g Salvia hispanica and White bread with added 15.58g Salvia hispanica in people with Post Prandial Blood Glucose, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post prandial capillary blood glucose levels (time frame: 2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2009.