Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05263011 |
| Other study ID # |
IRB-2021-81 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
February 1, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Clinical Nutrition Research Center, Illinois Institute of Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Compare the effects of three evening snacks on morning fasting and postprandial glucose and
insulin concentrations in individuals with prediabetes.
Description:
The study is a single-center, randomized, single-blinded, 3-arm, and cross-over study design.
Participants will be randomized to receive three eventing snack in randomized order:
low-fiber, low-fat control snack (low-fat yogurt); whole avocado snack; or control snack +
fiber supplement + vegetable oil, which will be consumed in the evening before the clinic
visit. Twelve hours (12 h) after snack intake (based on subjects typical evening snack and
morning breakfast routine), participants will report to the clinic for fasting blood draws,
followed by a standard meal with a minimum of 50 g available carbohydrate, and repeated blood
collection for 3 hours. On the day of "snack" intervention (ie., 24 h before standard meal
testing), subjects will be guided to follow their typical dietary pattern in consultation
with staff. Food diaries with a general plan will be used as a tool to help with dietary
compliance.
STUDY PROCEDURES: SCREENING VISIT:
Interested subjects will be asked to come to the Clinical Nutrition Research Center (CNRC) on
the IIT Campus, Chicago, IL, where the study will take place for a screening visit to
determine if they are eligible to participate in the study. The screening visit will take 2
hours. Prospective subjects must read, sign and date a written Institutional Review Board
(IRB) approved Informed Consent Form prior to performing any study procedure.
At the on-site screening visit, subject will be asked to arrive after overnight fasting for
10-12 hours and be well-hydrated. Subject will be instructed to aim for a water intake of at
least 8-10 cups for the 24 hours before the screening visit. Determining eligibility to
participate includes having subjects to complete a series of questionnaires related to their
health, medication use, dietary habits, and physical activity history. Anthropometrics
(height, weight and waist circumference), body composition, ear temperature, and vital signs
(blood pressure and heart rate) will be measured. For women under the age of 60 years, a
pregnancy test will be conducted. Body mass index (BMI) will be calculated from height and
weight measurements. Fasting blood glucose level by capillary blood from finger prick will be
tested. For vital sign measurements, subjects will sit in a comfortable chair, feet uncrossed
and on the floor and will be asked to rest quietly for 5 minutes before measuring blood
pressure and heart rate. Arm vein will be assessed using a vein access scale test. Subject
will be instructed to complete a 24-hour food recall.
Based on the results of the questionnaires, BMI calculation, and health evaluation, subjects
who meet the inclusion and exclusion criteria will be invited to participate in the study.
Eligible subjects will be trained and instructed to record all food and beverages consumed
for a 24 hour period on food record diarie using ASA24. Subjects will be asked not to take
any allergy medications and/or any pain medications such as Aspirin, Excedrin, Ibuprofen
(Advil, Motrin, Nuprin), Naproxen, or Aleve within 48 hours of each scheduled study days.
Tylenol is allowed. If they need to take allergy/pain medication 48 hours prior to their
study day, we will ask them to let the study investigators know so they can be rescheduled.
Before leaving the CNRC, subjects will be provided with written instruction for "how to
prepare for your study visit". This will include instructions for eating a standardized
dinner meal the night before the study day, consume the assigned study snacks, fasting
overnight (10-12 hours), avoidance of vigorous physical activity, alcoholic and caffeinated
beverage consumption for at least 24 hours preceding a study day, maintain regular sleep
pattern and usual diet except for the guidance provided for "foods and beverages to avoid or
limit". If subject did not get enough sleep during the night preceding a study day, we will
ask them to let us know so we can reschedule their study day.
STUDY DAYS:
Participation in this study will last approximately 2 to 3 weeks and include 3 Study Day
visits to the CNRC. Each Study Day visit will last about ~3.5 hours.
The day before each of the Study Day visits, subjects will be asked to come to the Center to
pick up a dinner meal and evening snack and will be asked to consume only the provided dinner
meal and snacks the evening before the visit. Subject will be provided with guidance on how
to maintain the same dinner intake, and when to consume the snacks (12 hour before the
scheduled study visit time, schedule based on the subject's typical evening snack and morning
breakfast routine) 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 after regular sleep the night
before. If they are taking medication(s) each morning, they will be asked not to take the
medication(s) at home and instead to bring to the CNRC to be taken in the presence of the
study investigator so the medications(s) is taken at the same time before each Study Day
visit.
Study protocol adherence will be corroborated by asking about the period of fasted state.
Subject will also be asked about their detailed food intake the 24-hour period prior to the
visit to ensure consistency and compliance with the protocol requirements. Subjects
experiencing unusual stressful events (such as loss of job, loss of loved one, divorce,
etc...) or having active infection will be rescheduled to a later time agreed upon by the
subject and investigator. Participants having experienced active infection can be rescheduled
when symptoms have been gone for at least 5 days and been off treatment (ex. Antibiotics) for
same time duration. The test period will be extended for study completion in these cases.
Subject will be asked about their medication intake and health status since their last visit
to ensure that subjects are maintaining their good health and medication intake.
After confirming compliance with the protocol, anthropometric measurements, and vital signs
(blood pressure, heart rate and ear temperature) will be taken. A finge prick for fasting
blood glucose will be taken to confirm if the subject is fasting. A licensed healthcare
professional (LHCP) will evaluate and place a catheter on the antecubital site of the
subject's non-dominant arm or arm of preference by subject. A catheter is a thin flexible
tube that allows sampling of blood through one port throughout the Study Day. Once the
catheter is placed, a blood sample will be taken (Time point T 0). After completing baseline
blood sampling, subjects will receive a standard meal with a minimum of 50 g available
carbohydrate to consume within 10 minutes. After the test food is consumed, additional blood
samples will be taken at 15, 30, 45, 60, 90, 120, 180 minutes after the start of breakfast
consumption. Subjects are allowed to drink water and the amount will be recorded. 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 snack and written instructions in preparation
for the next visit. Study day visits will be scheduled at least 3 days apart. Study Day 2 and
3 will be exactly the same as Study Day 1 except the evening snacks to consume before each
Study Day. Blood collection: Blood will be collected a total of 7 times on each Study Day
visit and 4 mL of the blood sample will be collected at each time point at each Study Day
visit. Over the course of the whole study, the total amount of blood collected will be ~84
mL, which is less than what is allowed for a one-time blood donation (~550 mL).
Adverse Events (AEs) will be assessed throughout Study Day visit. In an emergency while the
study subject is at CNRC, a LHCP will be on site to monitor the subject. In the unlikely
event of a medical emergency, 911 and emergency response will be called to the site. The
adverse event will be documented, determined as treatment-related or non-treatment related by
the Investigator and submitted to the IRB within 3 days or sooner for treatment related
adverse events. Serious adverse events (SAE) will be reported within 24 hours of our
knowledge of the SAE. A copy will be filed in the subject's study chart. Study staffs are
also trained and certified in CPR techniques.
In the event of an after-hours emergency, subject will be advised to obtain medical attention
as appropriate for the described symptoms. The subject is not required to contact the
Investigator prior to seeking medical attention, however will be required to report the
adverse event to the study manager or study coordinator at the next scheduled contact or
sooner if appropriate.
Retention and Compliance:
This study will include periodic telephone reminder calls along with in-person contact for
study day visits. Phone calls will be made to remind subjects to record food intake
(according to the subject specific pre-determined food record schedule), maintain consistency
in their overall diet and exercise habit prior to the Study Day visit and to confirm visit
schedules.
