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Dietary Supplement
First product order: order not stated to protect study blinding for Blood Sugar
N/A
Recruiting
Led By Dawn Beckman, MD
Research Sponsored by Ocean Spray Cranberries, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
Study Summary
This trial tests how snacks made from different fruits affect blood sugar and insulin in healthy people.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucose maximal concentration (Cmax) 2 hours after consumption
Secondary outcome measures
Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min
Glucose time to maximum concentration within 2 hours after consumption
Insulin incremental area under the curve (iAUC) from pre-product consumption to 120 min
+2 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Third product order: order not stated to protect study blindingExperimental Treatment5 Interventions
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Group II: Second product order: order not stated to protect study blindingExperimental Treatment5 Interventions
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Group III: Fourth product order: order not stated to protect study blindingExperimental Treatment5 Interventions
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Group IV: First product order: order not stated to protect study blindingExperimental Treatment5 Interventions
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Group V: Fifth product order: order not stated to protect study blindingExperimental Treatment5 Interventions
Participants will receive each of the 5 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7 day wash-out period before beginning the next product in the sequence
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
White Bread
2019
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Ocean Spray Cranberries, Inc.Lead Sponsor
5 Previous Clinical Trials
479 Total Patients Enrolled
Dawn Beckman, MDPrincipal InvestigatorBiofortis Innovation Services
8 Previous Clinical Trials
465 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must maintain your usual diet, including consistent intake of any vitamins, minerals, supplements and medications that are not expected to affect the results of this study.You have achieved a score between 7 and 10 on the Vein Access Scale at visit 1 (as outlined in the Appendix).You must be between 18-45 years old at visit 1.You have been diagnosed with an eating disorder like anorexia, bulimia, or binge eating by a doctor or other healthcare professional.You have allergies or sensitivities to any of the ingredients in the study product.You are prepared to keep up your usual level of physical activity over the course of the study.You have taken medications or supplements that can affect how your body processes carbohydrates in the past month.You have very strict or unusual eating habits, like following a special diet, which will be decided by the doctor in charge.You have had cancer in the past 2 years, except for non-melanoma skin cancer.You are currently trying to lose weight or plan to start a weight loss program during the study.You have not used tobacco or nicotine products within the last 12 months, and do not plan to start during the research.You abstain from consuming foods high in polyphenols (as outlined in Appendix 2) for 48 hours preceding each testing session.You possess no medical impediments to successfully completing the study, as verified by the Clinical Investigator via a review of your health history.You comprehend the study protocols, have signed documents offering knowledgeable consent to take part in the research and granted authorization to make available pertinent safeguarded health data to the Clinical Investigator.Your body mass index is between 18.5 and 30 kg/m2 at the initial visit.You have lost or gained more than 4.5 kilograms of weight in the 2 months before your first visit.Your fasting capillary glucose level is below 100 mg/dL at visit 1.You are required to abstain from alcohol for a period of 24 hours before each session.
Research Study Groups:
This trial has the following groups:- Group 1: First product order: order not stated to protect study blinding
- Group 2: Second product order: order not stated to protect study blinding
- Group 3: Third product order: order not stated to protect study blinding
- Group 4: Fourth product order: order not stated to protect study blinding
- Group 5: Fifth product order: order not stated to protect study blinding
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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