Weight ManagementNCT01731197
Satiating Effects of Isolated Soy Proteins
A study testing Dry-Blended Beverage in people with Weight Management, run by DuPont Nutrition and Health at 1 site in Canada.
Trial summary
Proteins are known to be more satiating than the other macronutrients; however, the type and amount of protein needed to induce a significant effect on satiety (fullness between meals) is sometimes difficult to determine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management
- What is being tested?
- Dry-Blended Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Nov 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 20 and 30 kg/m2
- Age between 18-65y
- Unrestrained eater (score<12)
- Regularly consume 3 meals per day
- Moderate exercise (eg running, aerobics classes, other sports activities) of no more than 7 hours per week
Who cannot join
- use of drugs that influence carbohydrate or lipid metabolism (eg. hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication, and anti-diabetic medication)
- presence of any significant disease (eg gastrointestinal diseases, diabetes, a CVD event less than 12 weeks from study entry, current hepatic disease, etc)
- use of special dietary treatments within 4 weeks of study (eg weight loss diet, extremely high or low carbohydrate/protein/fat diet, use of meal replacements more than once a day)
- use of supplements within 1 week of study (does not include vitamin supplements or supplements which are routinely taken and were initiated 4 weeks before the study and which will be continued during the study period)
- restrained eater (score>12)
- weight change (absolute body weight change of ≥ 10%) within the previous 6 weeks
Show all 10Show fewer
- alcohol intake >2 drinks/day
- food allergies of any kind
- swallowing difficulties
- exercising more than 7 hours per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Satiating Effects of Differentially Processed Isolated Soy Proteins
Proteins are known to be more satiating than the other macronutrients; however, the type and amount of protein needed to induce a significant effect on satiety (fullness between meals) is sometimes difficult to determine. In this study, 2 differentially processed isolated soy proteins will be tested for satiety using subjective visual analogue scales. The amount of food consumed following intake of the isolated soy proteins will be measured 3 hours after consuming the proteins. The hypothesis is that differentially processed isolated soy proteins will show unique satiety responses.
- Conditions
- Weight Management
- Being tested
- Dry-Blended Beverage
- Keywords
- obesity, isolated soy protein, satiety, food intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry-Blended BeverageDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Test ISP-10 | Experimental | 10 grams of the test ISP will be consumed as a dry-blended beverage Receives: Dietary Supplement: Dry-Blended Beverage |
| Test ISP-20 | Experimental | 20 grams of the test ISP will be consumed as a dry-blended beverage Receives: Dietary Supplement: Dry-Blended Beverage |
| Control ISP-10 | Active comparator | 10 grams of the control ISP will be consumed as a dry-blended beverage Receives: Dietary Supplement: Dry-Blended Beverage |
| Control ISP-20 | Active comparator | 20 grams of the control ISP will be consumed as a dry-blended beverage Receives: Dietary Supplement: Dry-Blended Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Satiety
Measure subjective satiety using visual analogue scales
Measured: 3 hours
Secondary outcomes (1)
Ad Libitum Food Intake
At the end of 3 hours after consuming test diets, measure the amount of food consumed for 30 mins
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- DuPont Nutrition and Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, MD, Principal investigator, Glycemic Index Laboratories, IncAlexandra Jenkins, PhD, Principal investigator, Glycemic Index Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731197
- Sponsor's protocol ID
- GIL-1245
- Status last verified
- Oct 2019
- First submitted
- 15 Nov 2012
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Satiating Effects of Differentially Processed Isolated Soy Proteins
- ClinicalTrials.gov ID
- NCT01731197
- Acronym / sponsor ID
- GIL-1245
- Conditions
- Weight Management
- Keywords
- obesity, isolated soy protein, satiety, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- DuPont Nutrition and HealthIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Nov 2012 (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.
Proteins are known to be more satiating than the other macronutrients; however, the type and amount of protein needed to induce a significant effect on satiety (fullness between meals) is sometimes difficult to determine. In this study, 2 differentially processed isolated soy proteins will be tested for satiety using subjective visual analogue scales. The amount of food consumed following intake of the isolated soy proteins will be measured 3 hours after consuming the proteins. The hypothesis is that differentially processed isolated soy proteins will show unique satiety responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test ISP-10 | Experimental | Dietary Supplement: Dry-Blended Beverage10 grams of the test ISP will be consumed as a dry-blended beverage |
| Test ISP-20 | Experimental | Dietary Supplement: Dry-Blended Beverage20 grams of the test ISP will be consumed as a dry-blended beverage |
| Control ISP-10 | Active comparator | Dietary Supplement: Dry-Blended Beverage10 grams of the control ISP will be consumed as a dry-blended beverage |
| Control ISP-20 | Active comparator | Dietary Supplement: Dry-Blended Beverage20 grams of the control ISP will be consumed as a dry-blended beverage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI between 20 and 30 kg/m2
- Age between 18-65y
- Unrestrained eater (score<12)
- Regularly consume 3 meals per day
- Moderate exercise (eg running, aerobics classes, other sports activities) of no more than 7 hours per week
Key exclusion criteria (10 listed)
- use of drugs that influence carbohydrate or lipid metabolism (eg. hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication, and anti-diabetic medication)
- presence of any significant disease (eg gastrointestinal diseases, diabetes, a CVD event less than 12 weeks from study entry, current hepatic disease, etc)
- use of special dietary treatments within 4 weeks of study (eg weight loss diet, extremely high or low carbohydrate/protein/fat diet, use of meal replacements more than once a day)
- use of supplements within 1 week of study (does not include vitamin supplements or supplements which are routinely taken and were initiated 4 weeks before the study and which will be continued during the study period)
- restrained eater (score>12)
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 |
|---|---|---|
| Dry-Blended Beverage | Dietary supplement | Control ISP-10, Control ISP-20, Test ISP-10, Test ISP-20 |
Primary outcome
Subjective Satiety
Time frame: 3 hours
Measure subjective satiety using visual analogue scales
1 secondary outcome
Ad Libitum Food Intake
Time frame: 30 minutes
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 7 Oct 2019.
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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.
Thomas Wolever, MD principal investigator
Glycemic Index Laboratories, Inc
Alexandra Jenkins, PhD principal investigator
Glycemic Index Laboratories, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry-Blended Beverage in people with Weight Management, run by DuPont Nutrition and Health 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 5 inclusion and 10 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 7 Oct 2019. 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?
Subjective Satiety (time frame: 3 hours). 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 7 Oct 2019.