Pregnancy - Prenatal TestingGRAPE-GDMNCT07323901
GRAPE-GDM Prospective Comperative Trial - Grape Juice as a Replacement Drink for Gestational Diabetes Screening
A study testing Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load. in people with Pregnancy - Prenatal Testing, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Study Type: Observational, prospective, multicenter comparative study Primary Purpose: The goal of this study is to evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening in pregnant individuals at 24-28 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy - Prenatal Testing
- What is being tested?
- Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Feb 2025to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant individuals scheduled for routine GCT at 24-28 weeks. Well-dated pregnancy (confirmed first-trimester ultrasound). Willingness to comply with study protocol.
Who cannot join
- High-risk individuals requiring direct 100g OGTT (e.g., prior GDM, BMI >40, PCOS).
- Intolerance to the alternative drink. Gastrointestinal conditions affecting glucose absorption such as active bowel disiease.
- Recent corticosteroid administration for fetal lung maturity after standard GCT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Study Type: Observational, prospective, multicenter comparative study
Primary Purpose: The goal of this study is to evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening in pregnant individuals at 24-28 weeks of gestation.
Read more
Main Questions:
Can an alternative glucose-loading drink (grape juice) provide comparable blood glucose measurements to the standard GCT? Does grape juice improve patient satisfaction and compliance with gestational diabetes screening?
Comparison Group:
Researchers will compare the standard GCT (50g glucola drink) with the alternative GCT (500 ml grape juice containing 50g sugar). Each participant will undergo both tests, serving as her own control, to assess differences in glucose measurements and patient preferences.
Participant Tasks:
Participants will:
- Undergo two glucose challenge tests (GCT): Standard GCT (50g glucola) at their health maintenance organization (HMO) or hospital.
Alternative GCT (500 ml grape juice) during a scheduled visit or hospitalization.
- Have blood drawn one hour after each test for glucose measurement.
- Complete a questionnaire assessing satisfaction and preference between the two methods.
- Provide follow-up information if they require additional testing (e.g., 100g OGTT).
Read the detailed description
Study Type: Prospective, observational, multicenter comparative study Primary Purpose: To evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening, with the goal of improving patient compliance and satisfaction.
Participant Population: Pregnant individuals at 24-28 weeks of gestation, undergoing routine glucose challenge testing (GCT). Participants will be recruited from Maternal-Fetal Medicine (MFM) clinics, prenatal maternal wards, and social media outreach.
Main Research Questions:
Can an alternative glucose-loading drink (grape juice) provide comparable blood glucose measurements to the standard GCT? Does grape juice improve patient satisfaction and compliance with gestational diabetes screening?
Study Design \& Methods:
Participants: Each participant will undergo both the standard GCT and an alternative GCT using 500 ml of grape juice (containing 50g of sugar).
Control Group: Each participant serves as her own control by completing both tests in a randomized order.
Blood Glucose Measurement: A blood sample will be drawn one hour after ingestion of each drink to compare glucose levels.
Follow-up: If necessary, follow-up phone calls will be conducted to collect results from the standard GCT performed at external clinics.
Outcome Measures:
Primary Outcomes:
Mean difference in blood glucose levels between the standard and alternative GCT.
Proportion of patients with a positive screening result (≥140 mg/dL) for both methods.
Sensitivity, specificity, and predictive values of the alternative GCT compared to the standard test.
Agreement between the two methods using Bland-Altman analysis.
Secondary Outcomes:
Patient satisfaction with both screening methods (measured via a Likert scale). Participant preference between grape juice and glucola. Incidence of adverse events (e.g., nausea, dizziness).
Statistical Analysis:
Pearson's correlation and paired t-tests will assess the agreement between glucose measurements.
ROC analysis will determine the diagnostic performance of the alternative test. Bland-Altman plots will evaluate bias and agreement between the two methods.
Sample Size Calculation:
A minimum of 120 participants is required to detect a clinically significant difference, accounting for attrition.
Recruitment Strategy:
Multicenter Approach: Enrollment from two major hospitals (Bnai Zion and Poria).
Social Media Outreach: Targeted campaigns will inform and recruit participants. Incentives: Participants will receive a complimentary MFM consultation and fetal ultrasound.
Significance:
If grape juice proves to be a viable alternative to the standard GCT, it could improve patient compliance, enhance screening participation, and minimize the discomfort associated with traditional glucose testing.
- Conditions
- Pregnancy - Prenatal Testing
- Being tested
- Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load.Other
This study investigates a non-carbonated, natural beverage (grape juice) as an alternative glucose-loading method for gestational diabetes screening. Unlike other studies that have explored alternative carbohydrate sources such as jelly beans or gummy candies-which require chewing and may impact dental health-our study focuses on a readily available liquid alternative that closely mimics the glucose absorption kinetics of the standard 50g glucola drink.
| Study group | Role | What they receive |
|---|---|---|
| grape juice | Experimental | Participants: Each participant will undergo both the standard GCT and an alternative GCT using 500 ml of grape juice (containing 50g of sugar).
Control Group: Each participant serves as her own control by completing both tests in a randomized order. Receives: Other: Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentration after test beverage
Venous plasma glucose ( measured at 60 minutes after each beverage
Measured: one hour from injestion of the drink
Secondary outcomes (3)
Participant satisfaction with glucose drink
Participant reported satisfaction with the consumed glucose drink, assessed using a 5 point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied).
Measured: One hour after ingestion of the glucose drink.
Participant preference for glucose challenge test drink
Participant stated preference for the alternative glucose drink compared with the standard glucose challenge test drink, recorded as a categorical variable (alternative drink preferred, standard drink preferred, no preference).
Measured: One hour after ingestion of the glucose drink.
Adverse events following glucose drink ingestion
Occurrence of self reported adverse events following ingestion of the glucose drink, including nausea and dizziness, recorded as present or absent.
Measured: One hour after ingestion of the glucose drink.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start19 Feb 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy - Prenatal TestingStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323901
- Sponsor's protocol ID
- BNZ-0122-24
- Acronym
- GRAPE-GDM
- Status last verified
- Mar 2025
- First submitted
- 7 May 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De identified individual participant data collected in this study will not be shared outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRAPE-GDM Prospective Comperative Trial - Grape Juice as a Replacement Drink for Gestational Diabetes Screening
- ClinicalTrials.gov ID
- NCT07323901
- Acronym / sponsor ID
- GRAPE-GDM / BNZ-0122-24
- Conditions
- Pregnancy - Prenatal Testing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 7 Jan 2026 (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.
Study Type: Observational, prospective, multicenter comparative study
Primary Purpose: The goal of this study is to evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening in pregnant individuals at 24-28 weeks of gestation.
Main Questions:
Can an alternative glucose-loading drink (grape juice) provide comparable blood glucose measurements to the standard GCT? Does grape juice improve patient satisfaction and compliance with gestational diabetes screening?
Comparison Group:
Researchers will compare the standard GCT (50g glucola drink) with the alternative GCT (500 ml grape juice containing 50g sugar). Each participant will undergo both tests, serving as her own control, to assess differences in glucose measurements and patient preferences.
Participant Tasks:
Participants will:
- Undergo two glucose challenge tests (GCT): Standard GCT (50g glucola) at their health maintenance organization (HMO) or hospital.
Alternative GCT (500 ml grape juice) during a scheduled visit or hospitalization.
- Have blood drawn one hour after each test for glucose measurement.
- Complete a questionnaire assessing satisfaction and preference between the two methods.
- Provide follow-up information if they require additional testing (e.g., 100g OGTT).
Detailed description
Study Type: Prospective, observational, multicenter comparative study Primary Purpose: To evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening, with the goal of improving patient compliance and satisfaction.
Participant Population: Pregnant individuals at 24-28 weeks of gestation, undergoing routine glucose challenge testing (GCT). Participants will be recruited from Maternal-Fetal Medicine (MFM) clinics, prenatal maternal wards, and social media outreach.
Main Research Questions:
Can an alternative glucose-loading drink (grape juice) provide comparable blood glucose measurements to the standard GCT? Does grape juice improve patient satisfaction and compliance with gestational diabetes screening?
Study Design \& Methods:
Participants: Each participant will undergo both the standard GCT and an alternative GCT using 500 ml of grape juice (containing 50g of sugar).
Control Group: Each participant serves as her own control by completing both tests in a randomized order.
Blood Glucose Measurement: A blood sample will be drawn one hour after ingestion of each drink to compare glucose levels.
Follow-up: If necessary, follow-up phone calls will be conducted to collect results from the standard GCT performed at external clinics.
Outcome Measures:
Primary Outcomes:
Mean difference in blood glucose levels between the standard and alternative GCT.
Proportion of patients with a positive screening result (≥140 mg/dL) for both methods.
Sensitivity, specificity, and predictive values of the alternative GCT compared to the standard test.
Agreement between the two methods using Bland-Altman analysis.
Secondary Outcomes:
Patient satisfaction with both screening methods (measured via a Likert scale). Participant preference between grape juice and glucola. Incidence of adverse events (e.g., nausea, dizziness).
Statistical Analysis:
Pearson's correlation and paired t-tests will assess the agreement between glucose measurements.
ROC analysis will determine the diagnostic performance of the alternative test. Bland-Altman plots will evaluate bias and agreement between the two methods.
Sample Size Calculation:
A minimum of 120 participants is required to detect a clinically significant difference, accounting for attrition.
Recruitment Strategy:
Multicenter Approach: Enrollment from two major hospitals (Bnai Zion and Poria).
Social Media Outreach: Targeted campaigns will inform and recruit participants. Incentives: Participants will receive a complimentary MFM consultation and fetal ultrasound.
Significance:
If grape juice proves to be a viable alternative to the standard GCT, it could improve patient compliance, enhance screening participation, and minimize the discomfort associated with traditional glucose testing.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| grape juice | Experimental | Other: Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load.Participants: Each participant will undergo both the standard GCT and an alternative GCT using 500 ml of grape juice (containing 50g of sugar). Control Group: Each participant serves as her own control by completing both tests in a randomized order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant individuals scheduled for routine GCT at 24-28 weeks. Well-dated pregnancy (confirmed first-trimester ultrasound). Willingness to comply with study protocol.
Key exclusion criteria (3 listed)
- High-risk individuals requiring direct 100g OGTT (e.g., prior GDM, BMI >40, PCOS).
- Intolerance to the alternative drink. Gastrointestinal conditions affecting glucose absorption such as active bowel disiease.
- Recent corticosteroid administration for fetal lung maturity after standard GCT.
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 |
|---|---|---|
| Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load.This study investigates a non-carbonated, natural beverage (grape juice) as an alternative glucose-loading method for gestational diabetes screening. Unlike other studies that have explored alternative carbohydrate sources such as jelly beans or gummy candies-which require chewing and may impact dental health-our study focuses on a readily available liquid alternative that closely mimics the glucose absorption kinetics of the standard 50g glucola drink. | Other | grape juice |
Primary outcome
Blood glucose concentration after test beverage
Time frame: one hour from injestion of the drink
Venous plasma glucose ( measured at 60 minutes after each beverage
3 secondary outcomes
Participant satisfaction with glucose drink
Time frame: One hour after ingestion of the glucose drink.
Participant preference for glucose challenge test drink
Time frame: One hour after ingestion of the glucose drink.
Adverse events following glucose drink ingestion
Time frame: One hour after ingestion of the glucose drink.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. De identified individual participant data collected in this study will not be shared outside the study team.
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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.
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 Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load. in people with Pregnancy - Prenatal Testing, run by Bnai Zion Medical Center at 1 site in Israel.
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 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: enrolling by invitation, as of the sponsor's last update on 7 Jan 2026. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
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?
Blood glucose concentration after test beverage (time frame: one hour from injestion of the drink). 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 Jan 2026.