Health TrialsbyHealthPanel

Postprandial Response to Fruit Juice

ConditionsBlood GlucoseBlood Insulin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorOcean Spray Cranberries, Inc.

About this trial

The goal of this clinical trial is to determine postprandial responses to fruit juices.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥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.

Disqualifiers

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 study protocol and/or affect study outcomes, in the judgment of the Clinical Investigator.

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Beverage 1

    Dietary supplement

    Fruit juice with zero sugar

  • Beverage 2

    Dietary supplement

    Fruit juice with low sugar - formulation 1

  • Beverage 3

    Dietary supplement

    Fruit juice with low sugar - formulation 2

  • Beverage 4

    Dietary supplement

    Fruit juice with full sugar

  • Beverage 5

    Dietary supplement

    Fruit juice with full sugar

  • Beverage 6

    Dietary supplement

    Glucose control beverage

Treatment groups

18 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: First product order: order not stated to protect study blindingExperimental treatment 6 interventions
Group B: Second product order: order not stated to protect study blindingExperimental treatment 6 interventions
Group C: Third product order: order not stated to protect study blindingExperimental treatment 6 interventions
Group D: Fourth product order: order not stated to protect study blindingExperimental treatment 6 interventions
Group E: Fifth product order: order not stated to protect study blindingExperimental treatment 6 interventions
Group F: Sixth product order: order not stated to protect study blindingExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Blood glucose iAUC - 2 hours

Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min

Time frame
2 hours

Secondary outcomes

1

Blood glucose maximal concentration

Plasma glucose maximal concentration (Cmax)

Time frame
2 hours
2

Blood glucose time to max concentration

Plasma glucose time to Cmax

Time frame
2 hours
3

Blood glucose change

Plasma glucose concentration change from (C-max) - (C-baseline))

Time frame
2 hours
4

Blood insulin iAUC

Serum insulin incremental area under the curve (iAUC) from pre-product consumption to 120 min

Time frame
2 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ocean Spray Cranberries, Inc.

Lead sponsor

Biofortis Innovation Services

Collaborator

Source ClinicalTrials.gov
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