Diabetes MellitusSolsticeNCT02537587
Effect of Varying the Protein and Dietary Fiber Content of Energy Bars on Their Glycemic and Insulinemic Impact
A study testing 15/0, 15/0LS and 15/5 in people with Diabetes Mellitus, run by Glycemic Index Laboratories, Inc at 1 site in Canada.
Trial summary
The purpose of this study was to determine the effect of changing the amounts of resistant starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy bars. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- 15/0, 15/0LS and 15/5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Mar 2014
- 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
- Body mass index 20.0 to 34.9 kg/m²
- Fasting serum glucose <7.0mmol/L
- Non-smoker
Who cannot join
- Known to have diabetes
- Use of medications or presence of a medical condition considered by the principal investigator to increase risk to the participant or affect the results
- Known food allergy of any kind
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine the effect of changing the amounts of resistant starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy bars. The investigators also compared the glucose and insulin responses to the rates at which the food bars were digested in-vitro (in the test tube). The investigators thought increasing resistant starch and reducing sugar would reduce the glucose and insulin responses, and that adding protein would reduce glucose and increase insulin. The investigators also thought the glucose and insulin responses in people would be related to the rate of digestion of the food bars in-vitro.
- Conditions
- Diabetes Mellitus
- Being tested
- Control 1, Control 2, 15/0, 15/0LS, 15/5
- Keywords
- Blood glucose, Blood insulin, Humans, Postprandial, Carbohydrate, Protein, Resistant starch, Sugar
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control 1Other
67g of control bar
Control 2Other
86g of control bar
15/0Other
66g of experimental bar 15/0
15/0LSOther
84g of experimental bar 15/0LS
15/5Other
75g of experimental bar 15/5
10/5Other
72g of experimental bar 10/5
10/10Other
80g of experimental bar 10/10
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | Active comparator | 67g of Control energy bar containing 4g protein, 15g fat, 42g carbohydrate, 2g fiber, and 24g sugar. Receives: Other: Control 1 |
| Control 2 | Active comparator | 86g of Control energy bar containing 5g protein, 20g fat, 55g carbohydrate, 3g fiber and 30g sugar Receives: Other: Control 2 |
| 15/0 | Experimental | Experimental bar with 15% added resistant starch and 0% added protein; 66g portion containing 3g protein, 7g fat, 50g carbohydrate, 10g fiber and 16g sugar Receives: Other: 15/0 |
| 15/0-LS | Experimental | Experimental bar with 15% added resistant starch and 0% added protein with reduced sugar; 84g portion containing 4g protein, 8g fat, 55g carbohydrate, 15g fiber and 15g sugar Receives: Other: 15/0LS |
| 15/5 | Experimental | Experimental bar with 15% added resistant starch and 5% added protein; 75g portion containing 9g protein, 7g fat, 52g carbohydrate, 12g fiber and 17g sugar Receives: Other: 15/5 |
| 10/5 | Experimental | Experimental bar with 10% added resistant starch and 5% added protein; 72g portion containing 10g protein, 8g fat, 49g carbohydrate, 9g fiber and 19g sugar Receives: Other: 10/5 |
| 10/10 | Experimental | Experimental bar with 10% added resistant starch and 10% added protein; 80g portion containing 17g protein, 7g fat, 49g carbohydrate, 9g fiber and 18g sugar Receives: Other: 10/10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the blood glucose response curve
Measured: For 3 hours after consuming each test meal
Secondary outcomes (6)
Incremental area under the serum insulin response curve
Measured: For 3 hours after consuming each test meal
Incremental area under the blood glucose response curve
Measured: For 2 hours after consuming each test meal
Incremental area under the serum insulin response curve
Measured: For 2 hours after consuming each test meal
Insulin:Glucose area under the curve ratio
Outcome 2 (incremental area under the insulin response curve for 3 hours) divided by Outcome 1 (incremental area under the glucose response curve for 3 hours)
Measured: For 3 hours after consuming each test meal
Insulin:Glucose area under the curve ratio
Outcome 4 (incremental area under the insulin response curve for 2 hours) divided by Outcome 3 (incremental area under the glucose response curve for 2 hours)
Measured: For 2 hours after consuming each test meal
Insulinogenic index
I30 divided by G30; where I30 is the serum insulin increment at 30 minutes and G30 is the blood glucose increment at 30 minutes; and where "increment" is defined as the concentration at 30 minutes minus the fasting concentration.
Measured: 30 minutes after consuming each test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycemic Index Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PepsiCo Global R&D
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, Glycemic Index Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537587
- Sponsor's protocol ID
- GIL-1342
- Other IDs
- PEP-1324
- Acronym
- Solstice
- Status last verified
- Aug 2015
- First submitted
- 28 Aug 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolever TM, van Klinken BJ, Bordenave N, Kaczmarczyk M, Jenkins AL, Chu Y, Harkness L. Reformulating cereal bars: high resistant starch reduces in vitro digestibility but not in vivo glucose or insulin response; whey protein reduces glucose but disproportionately increases insulin. Am J Clin Nutr. 2016 Oct;104(4):995-1003. doi: 10.3945/ajcn.116.132431. Epub 2016 Aug 31.
PubMed 27581470
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Varying the Protein and Dietary Fiber Content of Energy Bars on Their Glycemic and Insulinemic Impact
- ClinicalTrials.gov ID
- NCT02537587
- Acronym / sponsor ID
- Solstice / GIL-1342
- Conditions
- Diabetes Mellitus
- Keywords
- Blood glucose, Blood insulin, Humans, Postprandial, Carbohydrate, Protein, Resistant starch, Sugar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Glycemic Index Laboratories, IncIndustry (pharma, biotech, devices)
- Collaborators
- PepsiCo Global R&D
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Sep 2015 (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.
The purpose of this study was to determine the effect of changing the amounts of resistant starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy bars. The investigators also compared the glucose and insulin responses to the rates at which the food bars were digested in-vitro (in the test tube). The investigators thought increasing resistant starch and reducing sugar would reduce the glucose and insulin responses, and that adding protein would reduce glucose and increase insulin. The investigators also thought the glucose and insulin responses in people would be related to the rate of digestion of the food bars in-vitro.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control 1 | Active comparator | Other: Control 167g of Control energy bar containing 4g protein, 15g fat, 42g carbohydrate, 2g fiber, and 24g sugar. |
| Control 2 | Active comparator | Other: Control 286g of Control energy bar containing 5g protein, 20g fat, 55g carbohydrate, 3g fiber and 30g sugar |
| 15/0 | Experimental | Other: 15/0Experimental bar with 15% added resistant starch and 0% added protein; 66g portion containing 3g protein, 7g fat, 50g carbohydrate, 10g fiber and 16g sugar |
| 15/0-LS | Experimental | Other: 15/0LSExperimental bar with 15% added resistant starch and 0% added protein with reduced sugar; 84g portion containing 4g protein, 8g fat, 55g carbohydrate, 15g fiber and 15g sugar |
| 15/5 | Experimental | Other: 15/5Experimental bar with 15% added resistant starch and 5% added protein; 75g portion containing 9g protein, 7g fat, 52g carbohydrate, 12g fiber and 17g sugar |
| 10/5 | Experimental | Other: 10/5Experimental bar with 10% added resistant starch and 5% added protein; 72g portion containing 10g protein, 8g fat, 49g carbohydrate, 9g fiber and 19g sugar |
| 10/10 | Experimental | Other: 10/10Experimental bar with 10% added resistant starch and 10% added protein; 80g portion containing 17g protein, 7g fat, 49g carbohydrate, 9g fiber and 18g sugar |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index 20.0 to 34.9 kg/m²
- Fasting serum glucose <7.0mmol/L
- Non-smoker
Key exclusion criteria (3 listed)
- Known to have diabetes
- Use of medications or presence of a medical condition considered by the principal investigator to increase risk to the participant or affect the results
- Known food allergy of any kind
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 |
|---|---|---|
| Control 167g of control bar | Other | Control 1 |
| Control 286g of control bar | Other | Control 2 |
| 15/066g of experimental bar 15/0 | Other | 15/0 |
| 15/0LS84g of experimental bar 15/0LS | Other | 15/0-LS |
| 15/575g of experimental bar 15/5 | Other | 15/5 |
| 10/572g of experimental bar 10/5 | Other | 10/5 |
| 10/1080g of experimental bar 10/10 | Other | 10/10 |
Primary outcome
Incremental area under the blood glucose response curve
Time frame: For 3 hours after consuming each test meal
6 secondary outcomes
Incremental area under the serum insulin response curve
Time frame: For 3 hours after consuming each test meal
Incremental area under the blood glucose response curve
Time frame: For 2 hours after consuming each test meal
Incremental area under the serum insulin response curve
Time frame: For 2 hours after consuming each test meal
Insulin:Glucose area under the curve ratio
Time frame: For 3 hours after consuming each test meal
Insulin:Glucose area under the curve ratio
Time frame: For 2 hours after consuming each test meal
Insulinogenic index
Time frame: 30 minutes after consuming each test meal
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 1 Sep 2015.
- Derived from this study: PubMed 27581470Wolever TM, van Klinken BJ, Bordenave N, Kaczmarczyk M, Jenkins AL, Chu Y, Harkness L. Reformulating cereal bars: high resistant starch reduces in vitro digestibility but not in vivo glucose or insulin response; whey protein reduces glucose but disproportionately increases insulin. Am J Clin Nutr. 2016 Oct;104(4):995-1003. doi: 10.3945/ajcn.116.132431. Epub 2016 Aug 31.
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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 MS Wolever, MD, 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 15/0, 15/0LS and 15/5 in people with Diabetes Mellitus, run by Glycemic Index Laboratories, Inc 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 3 inclusion and 3 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 1 Sep 2015. 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?
Incremental area under the blood glucose response curve (time frame: For 3 hours after consuming each test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02537587, which also lists 1 linked publication.
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 1 Sep 2015.