Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04171648 |
| Other study ID # |
19049 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2020 |
| Est. completion date |
March 18, 2020 |
Study information
| Verified date |
September 2020 |
| Source |
North Carolina State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Research on glycemic control related to nuts or whole snack foods has focused primarily on
tree nuts. Different processing and cooking methods have not been comprehensively analyzed to
observe the effect on nutrient quality, bioavailability, or digestive absorption in peanuts.
There is little to no research surrounding the nutrition of boiled peanuts so it may be of
interest to compare boiled to roasted peanuts in terms of glycemic control. Peanuts have been
shown to have a similar beneficial effect on glycemic control while being more financially
accessible than almonds. Glycemic control could be improved based on the low glycemic index,
high fiber, lipid, and or protein content of peanuts. The acute trial (phase 1) will
investigate the impact of preprandial peanut consumption on glycemic response. The
participants will complete an oral glucose tolerance test for both roasted and boiled
peanuts. The long term study (phase 2&3) consists of participants consuming one serving per
day of boiled or roasted peanuts in a four week crossover trial to observe any long term
impact of daily peanut snacking on glycemic control. (Wash out weeks occurring between all
trials.) At the conclusion of phase 2 & 3 an oral glucose tolerance test will be executed.
The subjects will self record a exercise/step count and diet dairy, weight and waist to hip
ratio will be measured weekly. The study will aim for a male and/or female healthy population
from 18-65 years of age at NCSU.
Description:
Participants will be recruited via flyers, oral presentations, and emails. The recruitment
methods will briefly describe the study, eligibility, and compensation asking potential
subjects to contact Brooke Wilson for more information (by email) in which Brooke will
respond by email with the time and place of the informational meeting that will include the
screening process of the health screening questionnaire. The questionnaire will be
attached/included in the response email so the interested individual may see if they are
eligible before coming to the meeting. The health screen questionnaire will not be kept by
the research team, if the participant says "yes" to any question they are determined to be
not eligible and investigators will shred all health questionnaires and no participant needs
to write their name on a questionnaire. At the informational meeting the study protocol,
schedule of phases including total hours required, risks and benefits, and compensation will
be discussed as well as physical copy of the consent form will be given to review. A health
screening questionnaire will be provided and the subject will fill it out privately and/or
ask questions if required. Those individuals who meet the initial eligibility criteria
included in the questionnaire and voluntarily signs the consent form will be asked to
schedule an oral glucose tolerance test as a following separate meeting that will determine
if their glycemic response meets the final eligibility. Oral Glucose Tolerance Test
ELIGIBILITY: (1 morning duration ~3 hours in lab) The investigators will inform participants
at the meeting (also described in consent form) that the test will start early in the morning
when they have not eaten anything since the previous evening, or at least 6 to 8 hours in
this fasted state. The screening will measure fasting blood glucose (one reading of blood
glucose before the test begins) and a glucose tolerance test will be done to rule out
subjects with insulin resistance. A glucose tolerance test measures changes in blood glucose
over a 2-hr period after consuming a glucose drink containing 50 g of glucose. Blood samples
will be taken at 10, 20, 30, 40, 50, 60, 75, 90, 105, and 120 min after consuming the
treatments using a glucometer to take capillary blood samples (finger-pricks); (The "oral"
descriptor of the test refers to the fact that the individual orally ingests a 50 gram
glucose drink which mimics a standard meals spike in the blood glucose response. The "oral"
differentiates the method of administering glucose, such as in other cases the glucose can be
injected intravenously instead of ingested through food or drink form. All glucose tolerance
tests will monitor blood glucose by using continuous glucometers or drawing blood in
increments of time.) No participant will be left alone during the oral glucose tolerance
test, during all tests Brooke Wilson and a second research team member will be with the
participants. Brooke Wilson and staff will measure height, hip to waist ratio and weight of
the subjects. These measurements will be taken in a private room, with two staff at all time
that are the same gender as the participant, and everyone will be fully clothed during all
times. Professors will not take any measurements. Height and weight are measured to calculate
body mass index over the course of the study to observe any weight changes that may be
associated with a change in diet. Measuring hip to waist ratio will give a more accurate idea
of weight distribution, general health, and risk of certain diseases. Subjects with glucose
responses considered normal/healthy will be invited to continue in the study. It is possible
that a participant could pass the health screen questionnaire, sign the consent form, and
then fail the oral glucose tolerance test in which they will not be allowed to continue in
the study and will not be compensated in any form. The consent form must be signed before the
oral glucose tolerance test to determine eligibility for the participants safety and
awareness of risks. The oral glucose tolerance test conducted for eligibility will also
function as a baseline reading for those participants who complete the study. The health
screening questionnaire will be shredded immediately after the subjects agree to participate
or are disqualified from the study. (If disqualified the oral glucose tolerance test data
will be destroyed as well.) This study consists of three parts. The first being phase 1, the
second being phase 2, and the third being phase 3. The phase 1 data will stand on its own in
the reporting of this study. The long term study is separated into two parts (phase 2 and
phase 3) because it is a cross over study, meaning in phase 2 participants will be given
either roasted or boiled peanuts (by random assignment) to consume daily for two weeks, then
a wash out week will separate phase 2 and 3, and then phase 3 (by the same protocol as phase
2) with the same participants EXCEPT the food treatments will be switched (those who ate
roasted peanuts in phase 2 will eat boiled peanuts in phase 3 and vice versa). The data from
phase 2 and 3 will be reported together as the experimental design requires each participants
to do both treatments. In terms of a time line the phases will be conducted in this order:
(Screening and Eligibility - includes 1 oral glucose tolerance test) 1.Phase 1 (includes 2
oral glucose tolerance tests) 2.Wash out week 3.Phase 2 (includes 1 oral glucose tolerance
test) 4. Wash out week 5.Phase 3 (includes 1 oral glucose tolerance test) PHASE 1: (2 morning
duration in 1 week ~6 hours in lab) Participants will complete an oral glucose tolerance test
(OGTT) for the boiled peanut, and roasted peanut treatment (the eligibility oral glucose
tolerance test will serve as the control group for phase 1). In the duration of one week the
participants will come in on a Wednesday morning for the boiled peanut OGTT and a Friday
morning to complete the roasted peanut OGTT. Both OGTT sessions will be conducted as
followed: The participants must be fasted when arriving at the lab, meaning they have not
eaten in the last 6-8 hours for the scheduled test early in the morning. The participant will
consume their treatment food 0 to 15 minutes before consuming the 50g glucose drink. Once the
50 g glucose drink (must be consumed within 10 minuted) is consumed the OGTT will be
conducted the same as the eligibility OGTT. The change in blood glucose will be measured over
a 2-hr period immediately after consuming the treatment food and 50g glucose drink, blood
samples will be taken at 10, 20, 30, 40, 50, 60, 75, 90,120 min using a glucometer to take
capillary blood samples (finger-pricks); Investigators will measure height, hip to waist
ratio and weight. WASH OUT WEEK: (1 week duration) The participants will return to a free
living protocol and will not consume any phase samples (roasted or boiled peanuts) between
the phase 1, phase 2 and phase 3. (Participants will be instructed to record all data
(exercise/steps and diet) on a paper data collection sheet/diary supplied throughout all
phases. At the conclusion of the study during the last glucose tolerance test the
participants will hand in their food/exercise diary to Brooke Wilson, the diaries will be
immediately transported by her on foot to room 221 of Schaub Hall, locked in a drawer of the
graduate office (only Brooke Wilson has the key to the drawer) in which the door to enter the
office is locked by a card reader only accessed by associated staff. Investigators will
provide a pedometer to participants if they do not have one so they can measure daily
activity as a step count. Refer to "19049 information sheet for participant" supporting
document for the instructions given to participants on how to use the glucometer, the
pedometer, and food restrictions required.) PHASE 2: (2 week duration) Participants will be
randomized into the boiled peanut or roasted peanut treatment group. When the participants
return to the lab, they will be given the two weeks worth of samples (14 portions of 48 gram
servings) for phase 2 (premeasured and separated into individual containers) that they will
consume once daily. Depending on the phase, roasted or boiled, they will be instructed on how
to properly store the food items to discourage foodborne illness. They will be instructed to
consume the sample around the same time everyday between lunch and dinner, to consume in one
sitting of 30 minutes instead of throughout the day, and to record the actual time the sample
is consumed. PHASE 2 ORAL GLUCOSE TOLERANCE TEST: (1 morning duration ~3 hours in lab) Once
the subjects have completed the two weeks of daily x peanut consumption they will complete a
oral glucose tolerance test. The participants must be fasted when arrived at the lab, meaning
they have not eaten in the last 6-8 hours for the scheduled test early in the morning. The
change in blood glucose will be measured over a 2-hr period immediately after consuming a 50g
glucose drink. Blood samples will be taken at 10, 20, 30, 40, 50, 60, 75, 90,120 min after
consuming the drink using a glucometer to take capillary blood samples (finger-pricks);
Investigators will measure height, hip to waist ratio and weight. WASH OUT WEEK: (1 week
duration) The participants will return to a completely free living protocol and will not
consume any phase samples between phase 2 and phase 3. PHASE 3: (2 week duration) The same
procedure for the phase 2 will be used for phase 3 except the groups will switch respective
phase samples. PHASE 3 ORAL GLUCOSE TOLERANCE TEST:(1 morning duration ~3 hours in lab) The
same procedure for the phase 2 oral glucose tolerance test will be used for phase 3.
Investigators will measure height, hip to waist ratio and weight. Throughout the entire
procedure the participants may live their life as they normally would except for the
following rules. They are strongly discouraged from drinking whatsoever (especially more than
2 drinks per day and or drinking more than 4 drinks in two hours during any time of the
study). Also the participants should not do any non habitual exercise less than 10 hours
before any oral glucose tolerance test. A phlebotomist is not necessary as the lancing of
fingers to obtain enough blood for the glucometer is a common practice and instrument is sold
over the counter. As well the glucometer only requires about 50 microliters per finger stick
or less, each participant will be required to do five oral glucose tolerance tests including
10 finger lances per test. So in total the greatest amount of blood each participant will
draw is 2,500 microliters or the equivalent of 2.5 milliliters. The instruction below of how
to properly use a glucose monitor, including lancing of the finger, has been sourced from the
Centers for Disease Control and Prevention: -Make sure the glucometer is clean and ready to
use, turn on the glucometer. -Wash hands with soap and warm water. Dry well. Massage the
hands to get blood into the finger. -Remove the cap off the lancet device, insert lancet
until a click is heard to ensure it is secure, twist off the protective top to the lancet
exposing the needle and cap the lancet device. -After removing a test strip, immediately
close the test strip container tightly. Test strips can be damaged if they are exposed to
moisture. -Insert the test strip into the glucometer; check to make sure the glucometer is
on. - Place the lancet against the side of the preferred finger; press the button to lance
the finger. Prick the finger on the side rather than the tip or pad of finger for less pain.
Squeezing from the base of the finger (if it requires a lot of force or no blood is coming
out stop and lance again in a different location), gently place a small amount of blood onto
the test strip. -After a few seconds, the reading will appear. Track and record the results.
-Properly dispose the lancet by removing the lancet device top, recapping the lancet itself
and pull the capped lancet out of the device and throw it away. Remove test strip from
glucometer and put in appropriate trash container.
https://www.cdc.gov/diabetes/managing/managing-blood-sugar/bloodglucosemonitoring.html
Pedometer information: PedUSA CW Step Pedometer The pedometer provided only records the
amount of steps taken between clearing of data (a button to reset the step count each day).
The pedometer does not track any other data than a step count. The participants are allowed
to provide their own step counter, in the form of a Fitbit, smart watch, Garmin etc, as long
as the device used for the participant is consistent throughout the study. Any step counter
apps (not provided) have separate terms of service that may indicate that the users
information is shared with third parties that are not the research team, and the information
is not confidential. The research team is not responsible for any data shared through these
apps as the use of these apps and the awareness and agreement of their terms of use are at
the discretion of the participant. *Please refer to the document "MyFitnessPal and
Alternative Step Counter Use: Information Related to Personal Data Confidentiality" provided
to all participants discussing the data/personal information confidentiality using these
technology. * In all situations the participants must physically write down or record their
steps in their food diary/exercise diary to be collected by us at the end of each phase. If
the pedometer is lost or broken the subject will be provided with a replacement. 50 gram
glucose drink information: Azer Scientific Glucose Tolerance Beverages, manufacture # Azer
Scientific 10O050, catalog # 22-026-203. The beverage is in compliance with Food and Drug
Administration, World Health Organization, and American Diabetes Association. It comes in a
premeasured factory sealed bottle ready for consumption and stored at room temperature.
Through the course of this study, the participant will spend 15 hours at a lab testing blood
glucose levels (in 3-hour sessions) plus 10 minutes per day tracking food and exercise. The
total amount of time the participants will spend in this study is 21 hours.
