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Our pilot study is designed with the intention of discovering the role of carbohydrate timing within
metabolism as it affects weight loss, body fat percentage, and blood lipid values. Specifically, we are
aiming at looking at the affects that the timing of consumption of carbohydrates has on the body. We can
conclude based on results of any body fat % change if the metabolic pathway of de novo lipogenesis has
occurred or not. This is a topic in nutrition and health today that is very controversial. There are many
misconceptions about carbohydrates and there are many contrasting research articles and findings
concerning the timing of consumption of them and how it affects body weight and body fat storage. We
will be performing a randomized control trial with 20 men and women (10 men, 10 women) of all
ethnicities and socioeconomic statuses. All participants of our study will reside in a fully controlled
retreat facility over the course of 6 weeks with both their diet and physical activity monitored and
accounted for. Half of the participants will be consuming 60% of their daily carbohydrate needs at dinner
(7:00 pm) and half of the participants will be consuming 60% of their daily carbohydrate needs at
breakfast (7:00 am). On the first day of weeks 1, 3, and 6, all participants will have certain biomarkers
tested. We will be using a BodPod machine to collect body weight and body fat percent and an Alere
Cholestech LDX Analyzer to collect blood lipid levels. On the first day of weeks 2, 3, 4, 5, and 6 we will
give each participant a questionnaire, which will ask questions concerning the adequacy and overall
adaptivity of their diets thus far.
Results from this study could potentially be useful in furthering current research already done on
carbohydrates. There is not enough current research that explains how the timing of consumption of this
macronutrient affects the body. Therefore, it is essential that additional and extensive research be done on
this topic so that we can gain a greater understanding and eventually be able to nutritionally counsel
individuals who may struggle with weight loss.
INTRODUCTION
We aim to discover the role of carbohydrate timing within metabolism as it effects weight loss, body fat
percentage, and blood lipid values. When distributing carbohydrates over the time of day we are able to
uncover the utilization of glucose within the body and see if de novo lipogenesis has occurred. This
allows us to make inferences based on whether or not carbohydrates should be consumed in the morning
versus in the evening, and in what amounts. We will be asking: Does the distribution of consumption of
60% of daily carbohydrate needs at dinner (7pm) vs. breakfast (7am) result in weight, body fat, and blood
lipid level increase in a randomized sample of 20 men and women in the U.S. in a 6 week randomized
control trial performed at a fully controlled retreat facility? By measuring body weight, body fat
percentage, as well as blood lipid markers, we are able to see the effects of carbohydrate timing
throughout the day on the body as an outcome over 6 weeks. Implications of this study will include the
ability to counsel individual on carbohydrate timing in regards to weight loss and overall blood lipid
improvement. This will allow populations to become healthier by not changing carbohydrate intake
amount but by changing the timing of their intake of carbohydrates. This randomized control trial will
allow us to continue carbohydrate research to discover the implications of carbohydrates on our diet when
looking at weight loss and overall health improvement.
LITERATURE REVIEW
INTRODUCTION
Carbohydrates are an integral part of a healthy and balanced diet. Along with other nutrients, they
facilitate energy into our cells for utilization and ultimately for survival. They provide the body with its
main source of fuel, carbohydrates can often be associated with weight gain (Wang, Patterson, Ang,
Emond, Shetty, & Arab 2014). On the other hand however, carbohydrates have been linked to weight loss
(Sofer, Eliraz, Madar & Frozy 2015). Exploring the timing in which high carbohydrate meals are
consumed may provide understanding of the critical function of this macronutrient in metabolism and
weight fluctuation. Carbohydrate timing differs from culture to culture and throughout history. The timing
of consumption can influence energy regulation and in time, obesity (Wang et al 2014). Weight and
overall health struggles lead us to consider key components encompassing carbohydrate research: the role
of carbohydrates at breakfast vs. dinner, low carbohydrates diets vs. high carbohydrate diets, and the
specific timing of the consumption of carbohydrates, all of which may have a significant impact on an
individuals biomarkers.
identified in groups who ate high carbohydrate dinners (Sofer et al 2015). On the contrary, in the
Energetics Study preformed at UCLA, subjects who consumed
the evening (after 5:00 p.m.) resulted in a 2x higher risk to become obese (Wang et al 2014).
Breakfast and dinner have been beneficial to health, however further research is needed on the importance
of these two meals, regarding the effect that the carbohydrate content may have on the body.
PURPOSE
To discover the role of carbohydrate timing within metabolism as it effects weight loss, body fat
percentage, and blood lipid values.
OBJECTIVES
i.
To discover if carbohydrate distribution timing effects weight loss, body fat percentage, and
ii.
iii.
HYPOTHESIS
We hypothesize that between the a.m. and p.m. group there will be no significant changes (p=0.05) on
values of weight, body fat percentage, and blood lipid values.
METHODS
Study is an analytical prospective pilot study.
Participants will be chosen based on volunteer basis. All ethnicities, SES, religion and gender will be
accepted. Exclusion criteria includes: age <18-50>, chronic diseases including metabolic syndrome, as
well as any food allergies and intolerances. All participants will be in a health retreat setting. All aspect of
diet and activity will be controlled, accounted for, and considered. Upon entry into our retreat facility,
participants will be instructed to arrive in the morning between 6 a.m. and 8 a.m. fasted for their
preliminary testing on site for one day approx. 3 hours. Participants will be instructed to arrive in one
communal location for testing. Participants will wait until their name is called for testing. Once called,
participants will go through the BodPod first, then following with blood lipid testing. All testing will be
done by trained staff. Data from preliminary testing will be immediately recorded into an electronic
spread sheet via iPad devices with specialized programming by the tester. Once blood lipid levels are
taken, participants will be free to go. Study will begin the following day. Data from preliminary testing
will then be analyzed and arranged to ensure control and experimental groups have similar participant
populations with coding for participants to ensure no bias. We will consider age, weight, and total
cholesterol in determining groups. Control and experimental groups will then be assigned double blind
and with coding numbers instead of names. Participants will be called and told to arrive at set location
depending on whether they are control or experiment. Participants are not allowed to contact each other.
Participants will arrive at 6 a.m. the following day to get room assignments as well as a debriefing on
what type of meals to expect. Study will carry on for 2 weeks and 6 days. On the first day of the 3 rd week,
participants will be individually called down at 7 a.m., 3 at a time to do testing until all testing is
complete. There will be 1 testing station, with the a.m. group being tested first followed by the p.m.
group. A trained staff member will accompany each station. Once participants have completed testing
they are handed a questionnaire and asked to fill it out. Once filled out, participants are free to go back
into the unit. Once again data will be immediately entered into an iPad program to ensure no data is lost.
Total testing time should take no longer than 45 min. Repeat testing procedure for week 4 and 6.
DATA ANALYSIS
All comparisons between control and experimental groups will be analyzed using a paired t-test. This test
will be performed to compare all values of total cholesterol, HDL, LDL, triglycerides, and body fat
percentage at weeks 1, 3 and 6 between participants own values. We will be using a paired t-test because
we are comparing one groups values against each other, which is dependent. A p-value of 0.05 will be
used due to human variability. All comparisons within one group will be analyzed using a standard t-test.
This test will be performed not only for averages, but also for values taken at week 1, 3, and 6 for all lab
values to compare the a.m. group vs. the p.m. group to determine effectiveness of this specific diet.
asked to take advantage of the retreats pool and gym to carry out normal daily activity. But, with this we
cannot control actual activity levels for every single participants. From participant selection, BMI will not
be considered. Actual participants may have varying BMIs. This must be accounted for when looking at
weight loss or weight gain, as well as body fat % and total cholesterol.
SUMMARY
In summary, we look forward to carrying out this study within the next 1-2 years. Upon approval of
funding from Nestle, we will begin preliminary work immediately. Involving 20 participants of many
SES, religions, and BMIs will allow us to draw greater conclusions from our results to apply them
towards a greater population. Upon analyzing results we can then draw conclusion about the metabolism
of carbohydrates and weight gain. We can conclude from our study whether de novo lipogenesis has
occurred and if so to what extent. Research on de novo lipogenesis is slim, so this will impact all future
studies on carbohydrates. Once our study has been completed and results are analyzed, we can then use
the information to plan a bigger study under the same Nestle Foundation funding. This will allow us to
test on a bigger, more varied population and allow for less statistical errors. We can use this study to draw
conclusions as well as test previous findings from pilot study.
APPENDICIES
BUDGET
A. PERSONNEL COSTS (TOTAL = $1,500)
a. 2 technicians which are trained to perform Cholestech analysis as well as Bodpod tests
b. 1 technician will be responsible for taking a blood sample for the Cholestech machine
and 1 will be responsible for running the Bodpod test. They will be responsible for
directly entering information into iPad soft wear provided.
c. Technicians will work 4, 8 hour days. Day 1 will be initial testing for all participants,
while following days will be testing in their assigned a.m. or p.m. group on weeks 1, 3,
and 6.
d. Technicians will be payed $10 an hour.
e. We will contract a foodservice provider to prepare meals on site. They will work full time
days at minimum wage (approx. $8/hr). Approx. 5 kitchen staff.
BUDGET TOTAL:
$7,000
INFORMED CONSENT
Date:
Patient name:
You are being asked to take part in a research study concerning how the timing of carbohydrate
consumption affects the human body in terms of body weight, body fat percentage, and blood lipid levels.
Please read this form carefully and ask any questions you may have before agreeing to take part in the
study.
The purpose of this study is to compare and contrast how consuming 60% of ones daily recommended
carbohydrates in the a.m. vs. the p.m. affects the overall biomarkers listed above.
Should you decide to participate, you will be attending an all-inclusive health and wellness retreat for a
total of six weeks. You will be placed into either a control group or an experimental group based upon
your preliminary test results. You will be named by a number code as to eliminate any sort of bias at any
given time. Once placed in a group, you will be given a room assignment and will be informed on what
type of meals to expect for the next six weeks. On the first day of weeks one, three, and six, your weight
and body fat percentage will be tested by a BodPod machine. On these same days, your blood lipid levels
will also be tested via the Alere Cholestech LDX Analyzer machine. Total testing time should take no
longer than forty-five minutes. In addition to testing your biomarkers, you will also be given a brief
questionnaire on the first day of weeks two, three, four, five, and six. These questionnaires will collect the
details concerning the adequacy and overall adaptivity of your diet thus far. The questionnaires will be
the same for each week.
Risks of the study may include hunger or satiety discomfort as you will be on a strict diet regimen.
However, the amount of food provided to you will be based off of a 2,000 calorie diet and will provide you
with all of the essential RDAs of nutrients. Benefits of this study include compensation of $100.00, meals
and living quarters fully paid for, as well as nutrition counseling based upon the tests that you will
undergo.
The records and results of this study will be kept confidential. In any report that we make public, we will
not include any information that will make it possible to identify you. Research records will be kept in a
locked file that only the research team will have access to.
Taking part in this study is completely voluntary, and you may choose to withdraw from the study at any
time and for whatever reason.
The researchers conducting this study are Melissa Trost and Kaydee Shaw. Please ask any questions you
have now. If you have questions or concerns later, you may contact Melissa Trost at
tros2258@vandals.uidaho.edu or contact Kaydee Shaw at shaw2226@vandals.uidaho.edu.
You will be given a copy of this form to keep for your records.
Statement of Consent:
I have read the above information, and have received answers to any questions I asked. I consent to take
part in this study.
SURVEY TO BE USED
Please circle one of the following options. Thank you for you participation.
1. How hungry are you immediately upon waking in the morning?
I am a little bit
I am
I am not
hungry, but I
moderately
hungry at all /
could go
hungry and
My stomach is
I am hungry
I am really
hungry and I
food soon
without food
want to eat
uncomfortable yet
for a while
soon
moderately
hungry, but I
hungry and
am not feeling
would be
full either
happy eating
I am not
I am very
I am hungry
hungry at all /
that I am
hungry and I
Full
uncomfortable
would like
a small snack
something
I have no
I have a
I have a
moderate
moderate
amount of
amount of
I have so much
I have little
I have a high
energy that I
still function
as much as I
better than I
usually do
usually do
the walls
I have no
I have a
I have a
moderate
moderate
amount of
amount of
I have so much
I have little
energy at all
I have a high
energy that I
energy but not energy and feel level of energy am bouncing off
still function
tired
as much as I
better than I
usually do
usually do
the walls
I have no
I have a
I have a
moderate
moderate
amount of
amount of
I have so much
I have little
I have a high
energy that I
still function
as much as I
better than I
usually do
usually do
the walls
I was
I was not
satiated at all
satiated
I was satiated
I was so satiated
I was very
moderately
and
that I was
satiated
satiated
comfortable
uncomfortable
satiated at all
satiated
I was satiated
I was so satiated
I was very
moderately
and
that I was
satiated
satiated
comfortable
uncomfortable
satiated at all
satiated
I was satiated
I was so satiated
I was very
moderately
and
that I was
satiated
satiated
comfortable
uncomfortable
9. Rate your overall satisfaction of the meals you were provided with (variety, taste, accessibility, etc.)
Very poor
Poor
Okay
Good
Very good
Excellent
10. How would you describe your overall well-being throughout this study?
Okay
Very poor
(sometimes
Good (mostly
happy,
happy, decent
Excellent (never
Very good
(depressed,
Poor (unhappy,
miserable,
semi-hungry,
sometimes sad,
energy levels,
high energy
levels high,
hungry, low
little energy)
energy levels
not hungry
varied, hunger
often)
levels, never
rarely hungry)
energy)
levels varied)
went hungry)
REFRENCES
1. Abbott, Swinburn, Ruotolo, Hara, Patti, Harper, Grundy, & Howard (1990). Effect of a highcarbohydrate, low-saturated-fat diet on apolipoprotein B and triglyceride metabolism in Pima
Indians. The Journal of Clinical Investigation. 88(2): 642-650. doi: 10.1172/JCI114756
2. Bandin, Scheer, Luque, Avila, Zamora, Madris, Gomeez-Abellah & Garulet (2014). Meal timing
affects glucose tolerance, substrate oxidation and circadian-related variables: A randomized, cross
3.
157.
4. Garaulet, Gomez-Abellan (2014). Timing of Food Intake and obesity: A novel association. Journal
of Physiology and Behavior. 134: 44-50.
5. Keim, Van Loan, Horn, Barbieri & Mayclin, (1997). Weight loss in greater with consumption of
large morning meals and fat-free mass is preserved with large evening meals in women on a
controlled weight reduction regimen. American Society of Nutritional Sciences. 127: 75-82.
6. Schlundy, Hill, Sbrocco Pope, & Sharp, T (1992). The role of breakfast in the treatment of obesity: a
randomized control trial. American Journal of Clinical Nutrition. 55:645-51.
7. Sofer, Eliraz, Madar & Froy (2015). Metabolic effects of obesity: a review. World Journal of
Diabetes. 1, 76-88.
8. Softer, Eliraz, Madar, & Froy (2015). Concentrating carbohydrates before sleep improves feeding
regulation and metabolic inflammatory parameters in mice. Journal of Molecular and Cellular
Endocrinology. 414 (2015) 29-41. doi: 10.1016.06.032
9. Stephens, Sautter, Holtz, Sharoff, Chipkin, & Braun (2007). Effect of timing of energy and
carbohydrate replacement on post-exercise insulin action. Applied Physiology and Nutrition
Metabolism. 32(6):1139-47.
10. Stubbs, Prentice, & James (1997), Carbohydrates and Energy Balance. Annals of the New York
Academy of Sciences 819: 4469. doi: 10.1111/j.1749-6632.1997.tb51798.x
11. Wang, Patterson, Ang, Emond, Shetty & Arab (2014) Timing of energy intake during the day is
associated with risk of obesity in adults. Journal of Human Nutrition and Dietetics. (Suppl. 2) 255262 doi: 10.1111/jhn.12141