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The primary objective of the study is to compare the effects of a whole apple, apple juice alone, and apple juice with pomace on 2 hr glycemic response as measured by maximal glucose concentration
This study is a randomized, 3-arm, within subject cross-over trial allowing for three acute evaluations of 100% Apple Juice (235 g), 100% Apple Juice with enzyme-treated apple pomace fiber (129 g apple juice with 106 g apple pomace), and raw apple (230 g with skin edible portion - not including core or stem) on glucose and insulin responses in fifty-two healthy men and women aged 20-45 years.
A planned sample size of 70 will be enrolled into the study. This study will require one initial screening visit and 3 study visits. This study will take approximately 3-4 weeks per subject to complete.
The initial screening visit will take ~2 hours and provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, body composition measurement, vital signs, fasting blood glucose test (finger prick), a vein access scale evaluation, online 24-hr diet recall, and completion of a survey relate to general eating, health, and exercise habits. For women, a pregnancy test will be conducted.
If willing and eligible to participate, subjects will be invited to participate in the study for 3 study day visits. Eligible subjects will be instructed to follow a relatively low polyphenolic diet for at least 1-week prior the beginning of the study and continue for the duration of the study.
Each Study Day visit will last about ~3 hours. The day before each of the 3 Study Day visits, subjects will be asked to consume the same dinner meal and record on a food record. At each Study Day visit, subjects will arrive at the clinic after fasting for 10 to 12 hours and in a well-hydrated and well-rested state.
Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed Health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. Subjects will be randomized to receive one of study products based on randomized treatment sequences for 3 study visits immediately after fasting blood draw.
Participants will come to the research site on 3 separate occasions separated by a washout period. On each occasion 2 fasting blood samples will be obtained at 5 min intervals (-5, 0 minute (min)). Subjects will then consume one of the 3 treatments. Further blood samples will be taken at 15, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 min. Self-reported visual analog scales (VAS) will be used to measure subject hunger, fullness, desire to eat, and prospective food intake at 0, 15, 30, 60, 90, and 120 min. After completion of all study procedures and data/sample collection for the day, the catheter will be removed and subjects will be evaluated for safety and/or discomfort/symptoms before leaving the study site. They will be given a take-home snack and given written instructions in preparation for the next visit. Study day visits will be scheduled at least 3 days apart but no more than 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apple Juice1 | Active Comparator | 100% Apple Juice |
|
| Apple Juice2 | Experimental | 100% Apple Juice with enzyme-treated apple pomace fiber |
|
| Raw Apple | Placebo Comparator | Raw Apple |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple Juice1 | Dietary Supplement | Apple Juice1 |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose maximal concentration (Cmax) over 2 hours | Plasma Glucose maximal concentration (Cmax) over 2 hours | Postprandial 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Plasma Glucose concentration as measured by incremental area under the curve (iAUC) over 2 hours | Changes in plasma glucose concentration as measured by iAUC over a 2-hour Postprandial Test day after administration of active treatment compared to control treatment | Postprandial 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to plasma glucose maximal concentration (Tmax) over 2 hours | Time to plasma glucose maximal concentration (Tmax) over 2 hours | Postprandial 2 hours |
| Plasma Insulin Cmax over 2 hours | Plasma Insulin Cmax over 2 hours |
Inclusion Criteria:
• Subject is a male or female, 20-45 years of age, inclusive.
Exclusion Criteria:
•Subject has fasting finger prick glucose >100 mg/dL.
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| Name | Affiliation | Role |
|---|---|---|
| Britt Burton-Freeman, Ph.D | Illinois Institute of Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
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| Apple Juice2 | Dietary Supplement | 100% Apple Juice with enzyme-treated apple pomace fiber |
|
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| Raw Apple | Dietary Supplement | Raw Apple |
|
| Postprandial 2 hours |
| Changes in plasma insulin concentration as measured by iAUC over a 2-hour period Postprandial Test day after administration of active treatment compared to control treatment | Plasma Insulin iAUC over 2 hours | Postprandial 2 hours |
| Time to Plasma Insulin Maximal concentration (Tmax) over 2 hour2 | Time to Plasma Insulin Maximal concentration (Tmax) over 2 hours | Postprandial 2 hours |
| Changes in postprandial subjective satiety responses using visual analog scales (VAS) of Hunger over 2 hours | Self-reported Subjective VAS of Hunger by placing a marker (ranged in 0 to 100 mm) on the line scale anchored by opposing terms(eg. From Extremely to Not at all) at designated timepoints | Postprandial 2 hours |
| Changes in postprandial subjective satiety responses using visual analog scales (VAS) of Fullness over 2 hours | Self-reported Subjective VAS of Fullness by placing a marker (ranged in 0 to 100 mm) on the line scale anchored by opposing terms (eg. From Extremely to Not at all) at designated timepoints | Postprandial 2 hours |
| Changes in postprandial subjective satiety responses using visual analog scales (VAS) of desire to eat over 2 hours | Self-reported Subjective VAS of Desire to eat by placing a marker (ranged in 0 to 100 mm) on the line scale anchored by opposing terms (eg. From Extremely to Not at all) at designated timepoints | Postprandial 2 hours |
| Changes in postprandial subjective satiety responses using visual analog scales (VAS) of Prospective food intake over 2 hours | Self-reported Subjective VAS of Prospective food intake by placing a marker (ranged in 0 to 100 mm) on the line scale anchored by opposing terms (eg. From Extremely to Not at all) at designated timepoints | Postprandial 2 hours |