Glycemic IndexGRAPENCT03916692
GRAPE • Glycemic Response of Amylopectin Containing Drinks
A study testing Carbohydrate drink, Energy smart Carbohydrate blend and Liquid Dextrose in people with Glycemic Index, run by Arizona State University at 1 site in United States.
Trial summary
To quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index
- What is being tested?
- Carbohydrate drink, Energy smart Carbohydrate blend and Liquid Dextrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 30 Aug 2021
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 27.5 to 35 kg∙m-2
Who cannot join
- Diagnosed diabetes
- HbA1c > 6.5
- competitive athletes
- body weigh change > 3kg during last month
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Official title: Glycemic Response of Amylopectin Containing Drinks
To quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.
The aim of the study is to quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.
Read the detailed description
Subjects: 9 non-diabetic (HbA1c < 6.5) males aged 30-55 years with body mass indices ranging from 27.5 to 35 kg∙m-2. Individuals with impaired glucose tolerance will be included as long as they are not diagnosed with diabetes and their HbA1c is less than 6.5.
Preliminary Testing: Medical history, weight, height, body composition via dual x-ray absorptiometry (DXA) and glycosylated hemoglobin (HbA1c) measurement.
Protocol: After a 10-hour overnight fast, subjects will complete 3 experimental visits in which they will ingest one of three beverages in a randomized order. During experimental visits subjects will either be given the following 3 experimental drinks:
- Full SP-glucose balance formula (200 kcal)
- Energy smart carbohydrate blend (50 g, 200 kcal)
- Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 g, 200 kcal)
- Conditions
- Glycemic Index
- Being tested
- Carbohydrate drink, Energy smart Carbohydrate blend, Liquid Dextrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate drinkDietary supplement
Also called SP-glucose balance formula
Meal replacement drink containing 200 kcal
Energy smart Carbohydrate blendDietary supplement
Carbohydrate blend drink designed for low glycemic responses containing 200 kcal
Liquid DextroseDietary supplement
Liquid Dextrose drink of 200 kcal
| Study group | Role | What they receive |
|---|---|---|
| Standard Process - glucose balance | Experimental | Standard Process - glucose balance formula (200 kcal) Receives: Dietary Supplement: Carbohydrate drink |
| Energy smart Carbohydrate blend | Experimental | Energy smart carbohydrate blend (50 grams, 200 kcal) Receives: Dietary Supplement: Energy smart Carbohydrate blend |
| Liquid Dextrose Control | Active comparator | Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 grams, 200 kcal) Receives: Dietary Supplement: Liquid Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of Glucose
Positive integer of the area under the Curve of glucose
Measured: 120 minutes
Area Under the Curve for Insulin
Positive integer of the area under the Curve of insulin
Measured: 120 minutes
Blood glucose
Blood glucose levels
Measured: 30, 60 and 120 minutes of the glucose challenge
Blood insulin
Blood insulin levels
Measured: 30, 60 and 120 minutes of the glucose challenge
Secondary outcomes (5)
c-peptide
Blood levels of c-peptide
Measured: 30, 60, and 120 minutes of the glucose challenge
glucagon
Blood levels of glucagon
Measured: 30, 60, and 120 minutes of of the glucose challenge
Leptin
Blood levels of leptin
Measured: 30, 60, and 120 minutes of the glucose challenge
Adiponectin
Blood levels of adiponectin
Measured: 30, 60, and 120 minutes of the glucose challenge
glucagon-like-peptide-1
Blood levels of glucagon-like-peptide-1
Measured: 30, 60, and 120 minutes of the glucose challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start23 Apr 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Why it stopped: Covid-19 restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic IndexStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Cross-over trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Standard Process Inc.
- Responsible party
- Sponsor
- Investigators
- Stavros Kavouras, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916692
- Sponsor's protocol ID
- FP00016578
- Acronym
- GRAPE
- Status last verified
- Sep 2022
- First submitted
- 12 Apr 2019
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Response of Amylopectin Containing Drinks
- ClinicalTrials.gov ID
- NCT03916692
- Acronym / sponsor ID
- GRAPE / FP00016578
- Conditions
- Glycemic Index
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 restrictions
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Standard Process Inc.
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 16 Apr 2019 (actual)
- 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.
To quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.
The aim of the study is to quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.
Detailed description
Subjects: 9 non-diabetic (HbA1c < 6.5) males aged 30-55 years with body mass indices ranging from 27.5 to 35 kg∙m-2. Individuals with impaired glucose tolerance will be included as long as they are not diagnosed with diabetes and their HbA1c is less than 6.5.
Preliminary Testing: Medical history, weight, height, body composition via dual x-ray absorptiometry (DXA) and glycosylated hemoglobin (HbA1c) measurement.
Protocol: After a 10-hour overnight fast, subjects will complete 3 experimental visits in which they will ingest one of three beverages in a randomized order. During experimental visits subjects will either be given the following 3 experimental drinks:
- Full SP-glucose balance formula (200 kcal)
- Energy smart carbohydrate blend (50 g, 200 kcal)
- Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 g, 200 kcal)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized Cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Standard Process - glucose balance | Experimental | Dietary Supplement: Carbohydrate drinkStandard Process - glucose balance formula (200 kcal) |
| Energy smart Carbohydrate blend | Experimental | Dietary Supplement: Energy smart Carbohydrate blendEnergy smart carbohydrate blend (50 grams, 200 kcal) |
| Liquid Dextrose Control | Active comparator | Dietary Supplement: Liquid DextroseLiquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 grams, 200 kcal) |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 27.5 to 35 kg∙m-2
Key exclusion criteria (4 listed)
- Diagnosed diabetes
- HbA1c > 6.5
- competitive athletes
- body weigh change > 3kg during last month
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 |
|---|---|---|
| Carbohydrate drinkAlso: SP-glucose balance formulaMeal replacement drink containing 200 kcal | Dietary supplement | Standard Process - glucose balance |
| Energy smart Carbohydrate blendCarbohydrate blend drink designed for low glycemic responses containing 200 kcal | Dietary supplement | Energy smart Carbohydrate blend |
| Liquid DextroseLiquid Dextrose drink of 200 kcal | Dietary supplement | Liquid Dextrose Control |
Primary outcome
Area Under the Curve of Glucose
Time frame: 120 minutes
Positive integer of the area under the Curve of glucose
Area Under the Curve for Insulin
Time frame: 120 minutes
Positive integer of the area under the Curve of insulin
Blood glucose
Time frame: 30, 60 and 120 minutes of the glucose challenge
Blood glucose levels
Blood insulin
Time frame: 30, 60 and 120 minutes of the glucose challenge
Blood insulin levels
5 secondary outcomes
c-peptide
Time frame: 30, 60, and 120 minutes of the glucose challenge
glucagon
Time frame: 30, 60, and 120 minutes of of the glucose challenge
Leptin
Time frame: 30, 60, and 120 minutes of the glucose challenge
Adiponectin
Time frame: 30, 60, and 120 minutes of the glucose challenge
glucagon-like-peptide-1
Time frame: 30, 60, and 120 minutes of the glucose challenge
Results and safety
The study was stopped early (reason given: Covid-19 restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Stavros Kavouras, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate drink, Energy smart Carbohydrate blend and Liquid Dextrose in people with Glycemic Index, run by Arizona State University at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 8 Sep 2022. 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 United States. 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 was stopped early (reason given: Covid-19 restrictions). Results are not available in the source record.
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?
Area Under the Curve of Glucose (time frame: 120 minutes). The study lists 4 primary outcomes in all. 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 8 Sep 2022.