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New treatment option for Blood Glucose
Official title Postprandial Response to Fruit Juice
ClinicalTrials.gov ID: NCT07103083
What this study is testing
- What it's testing
- The goal of this clinical trial is to determine postprandial responses to fruit juices.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- ≥18 to ≤45 years of age at Visit 1.
- BMI ≥18.5 and \<30.0 kg/m2 at Visit 1.
- Fasting capillary glucose ≤110 mg/dL at Visit 1.
- Willing to avoid consuming high-polyphenol containing foods for 48 hours prior to each test visit.
- Willing to abstain from alcohol consumption for 24 hours prior to each study visit.
You likely can't join if
- History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological...
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at...
- Unstable use (initiation or change in dose) within 30 days of Visit 1 of antihypertensive medications.
- Unstable use (initiation or change in dose) within 30 days of Visit 1 of thyroid hormone replacement medications.
- Use of medications or supplements that may influence carbohydrate metabolism within 30 days of Visit 1.
- Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
See the full eligibility criteria
Who can join
- ≥18 to ≤45 years of age at Visit 1.
- BMI ≥18.5 and \<30.0 kg/m2 at Visit 1.
- Fasting capillary glucose ≤110 mg/dL at Visit 1.
- Willing to avoid consuming high-polyphenol containing foods for 48 hours prior to each test visit.
- Willing to abstain from alcohol consumption for 24 hours prior to each study visit.
- Non-user of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of Visit 1, with no plans to begin use during the study period.
- Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including Cannabidiol (CBD)/Tetrahydrocannabinol (THC) products, and willing to abstain from use throughout the study period (topical...
- Willing to maintain habitual physical activity level throughout the duration of the study.
- Willing to maintain habitual dietary pattern throughout the duration of the study, including stable intake of current vitamins, minerals, supplements and medications not interfering with study outcomes.
- Score of 7 to 10 on the Vein Access Scale at Visit 1.
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
What rules you out
- History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders that may affect the participant's ability to adhere to the...
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Section 9.1.1).
- Unstable use (initiation or change in dose) within 30 days of Visit 1 of antihypertensive medications.
- Unstable use (initiation or change in dose) within 30 days of Visit 1 of thyroid hormone replacement medications.
- Use of medications or supplements that may influence carbohydrate metabolism within 30 days of Visit 1.
- Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
- Weight loss or gain \>4.5 kg in the 60 days prior to Visit 1.
- Currently, or planning to be, on a weight loss regimen during the study.
- Use of weight loss medication within 90 days of Visit 1.
- History of gastrointestinal surgery for weight reducing purposes.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- Known allergy or sensitivity to any ingredients or potential allergens contained in the study beverages.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- History of any major trauma or major surgical event within 60 days of Visit 1.
- Blood donation \>450 mL within 60 days of Visit 2 or plans to donate blood or plasma during the study period.
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use (initiation or change in dose) within 30 days of Visit 1) of sex hormones for...
- Recent history of (within 12 months of screening; Visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled...
- Exposed to any non-registered drug product within 30 days prior to Visit 1.
- Any condition the Clinical Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results...
The study team makes the final eligibility decision.
Where it's taking place
- Addison, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Addison, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.