How to cite this article: Nicholas G Morehouse, Kate Bauer, Vasuki Wijendran, Pei-Ra Ling, Charles Marsland, Stacey J Bell. Use of Nutrient- Dense Functional Foods in the Management of Type 2 Diabetes Mellitus. 2019; 12(2): 555834. DOI:10.19080/CRDOJ.2019.11.555834
Background: A poor diet, lacking in nutrients and rich in sugar, salt, and saturated fats, promotes obesity, which increases the risk of type 2 diabetes and, if present, makes management harder. Nutrient-dense, portion-controlled functional foods have shown promise in helping people lose weight. The purpose of this single arm, prospective, two-month study was to assess the effect of nutrient-dense functional foods on glycemic management in patients with type 2 diabetes, who were overweight or obese.
Methods: Subjects were recruited via social media and if they met the entry criteria were provided five, easy-to-prepare nutrient-rich functional foods each day. Self-reported measurement of body weight, fasting blood glucose (two times weekly), post-prandial blood glucose (two times weekly), and quality of life ratings were provided weekly; waist circumference was measured at baseline and monthly thereafter.
Results: Thirty-four subjects enrolled in the study and 18 completed it (53%). The mean age was 55± 8 years and the body mass index (BMI) average was 34±4; most were obese (85%). Most participants consumed three nutrient-dense meals daily (47%), while 17% consumed four meals and 17% five meals daily. Non-significant decreases occurred in mean body weight over the first four weeks (98±18 kg to 93±15 kg) and remained mostly unchanged at week 8 (92±15 kg). Weight loss at week 8 was 6%, which is considered to be medically significant. BMI decreased more between baseline and week 4 (34±4 to 32±3 kg/m2) compared to change between week 4 and week 8. Compared to baseline, BMI at week 4 (P = 0.01) and week 8 (P = 0.003) were significantly lower. Waist circumference decreased for both women (107±13 cm at baseline to 102±15 cm at week 8), and men (110±16 cm at baseline to 100±11 cm at week 8). Compared to baseline, at week four, post-prandial blood glucose, but not fasting concentrations, were significantly lower (216±72 vs. 172±54 mg/dL; p = 0.02). By week 8, both fasting blood glucose (P = 0.007) and post-prandial concentrations (P = 0.003) were significantly lower than at baseline. At baseline (n=33), the mean HgbA1c was 8.6±1.9 %. By week 8, the percent decrease exceeded what would be expected from oral antidiabetic agents (n=5; 0.5-1.25%). Each quality of life attribute improved significantly (P < 0.05) over the eight weeks, except gastrointestinal symptoms, with the greatest benefits were for improved diet quality, increased energy, better sleep, better appearance, and generally feeling better.
Conclusions: Eating well and controlling blood sugar go hand-in-hand. However, the diet of patients with type 2 diabetes is nutrient-poor and laden with harmful additives such as sugar, salt, and saturated fats, making management of the condition difficult. Inclusion of up to five, nutrient-dense functional foods that are low harmful additives was beneficial to individuals with type 2 diabetes by significantly improving glycemic control, for both fasting blood glucose and post-prandial concentrations. The decrease in HgbA1c exceeded what would have been expected from oral antidiabetic agents. These improvements were coupled with a 6% weight loss and decreases in waist circumference. New dietary strategies are needed for patients with type 2 diabetes and nutrient-dense functional foods may be a good option.
Keywords: Type 2 diabetes; Diet; Functional foods; Nutrient-dense foods; Blood sugar management; Diet and diabetes
According to the American Diabetes Association about 9.4% of the population has type 2 diabetes mellitus (about 30 million people) . Of this, about 25% are undiagnosed. However, including those who have prediabetes and are undiagnosed, the prevalence has been reported to be closer to 50% of the population . Diabetes is a group of chronic diseases characterized by hyperglycemia, which damages the
body . Generally, the injurious effects of hyperglycemia
are separated into macrovascular complications (coronary
artery disease, peripheral arterial disease, and stroke) and
microvascular complications (diabetic nephropathy, neuropathy,
and retinopathy). The relationship between dementia risk and
hemoglobin A1c (HgbA1c) has recently been identified .
Over ten years, HgbA1c levels were linearly associated with
subsequent cognitive decline irrespective of diabetes status at
The American Diabetes Association acknowledges that
the most challenging part of a diabetes treatment plan is
determining what to eat and then following a healthy meal
plan . The most comprehensive study, Look AHEAD, lasting
nearly ten years compared an intensive lifestyle management
program (i.e., diet, exercise, behavior) to a much less aggressive
dietary and educational intervention . Despite showing no
difference between the two groups for cardiovascular events
(the primary outcome), there were numerous benefits of the
intensive intervention group including: improved biomarkers
of glucose and lipid control, less sleep apnea, lower liver fat,
less depression, improved insulin sensitivity, less urinary
incontinence, less kidney disease, reduced need of diabetes
medications, maintenance of physical mobility, improved quality
of life, and lower costs. However, a newer analysis of these data
showed that a subset of participants experienced deleterious
effects from the combination of intensive lifestyle management
and weight loss .
It may be that the inability to reduce cardiovascular disease
(CVD) risk and avoid harm in some patients was that these things
were not considered: the genotypes of subjects, the numerous
anti-diabetes medications used that affect the metabolome
differently, and variations in the gut microbiome . Future
studies need to appreciate these variables, so that the findings
allow clinicians to design personalized nutritional approaches
for type 2 diabetes management.
Up to 90% of type 2 diabetes can be prevented by adopting
a healthy diet and lifestyles including engaging in physical
activity, getting adequate sleep, and not smoking . A healthy
diet is defined by one that is nutrient-dense, especially rich in
plant-based oils and proteins, fiber, and containing all essential
nutrients. Foods of high diet quality to include are vegetables,
fruits, nuts and legumes, long-chain fats, and whole grains.
Others of poor quality should be limited: sugar-sweetened
beverages, red and processed meat, saturated fat, and sodium;
and moderate alcohol consumption. Adoption of these dietary
recommendations was strongly associated with a lower type 2
diabetes risk. This eating pattern is supported based on a metaanalysis
including 48 studies .
Despite the overwhelming evidence of what constitutes a
healthy diet, paradoxically, it is rarely adopted by those with type
2 diabetes [11,12]. Most individuals with type 2 diabetes overconsume
what should be limited (e.g., salt, sugar, and saturated
fats) and under-consume the aforementioned healthy foods.
The poor diet is mainly from ultra-processed and addictive
foods, thus disallowing someone to lose weight and reduce
disease risk . Admittedly, these ultra-processed foods are
less expensive, tastier, have a long shelf life (i.e., will not spoil
like the recommended healthy foods), and are easier to prepare
than those that have been shown to reduce disease risk.
New dietary strategies are needed that are healthy and will
be incorporated into the lives of those with type 2 diabetes. One
popular approach is adhering to a ketogenic diet . The results
are promising, showing that being in ketosis was safe and can
improve HbA1c, weight, and other biomarkers, while reducing
diabetes medication use. However, a ketogenic diet appears to
offer no advantage in glycemic management compared to other
diets . In addition, adherence to a very low-carbohydrate
diet is tedious, and without careful management, could lead to
Functional foods that meet healthy dietary criteria may be
a useful way to lose weight and manage blood glucose levels.
These are foods enhanced with bioactive ingredients and have
demonstrated health benefits . Functional foods usually
have demonstrated beneficial physiological effects in the
prevention, management, and/or treatment of chronic disease
that is beyond basic nutrition. The functional foods can come
from conventional foods or from the addition of a bioactive
constituent in conventional food like vitamins and minerals.
Novel nutrient-dense, functional foods and beverages like
those used in this study have already been shown to produce a
medically significant weight loss [16,17].
The purpose of this prospective, single-armed study is
to evaluate the effect of nutrient-dense, portion-controlled,
functional foods and beverages in patients with type 2 diabetes.
For this single-armed, prospective dietary study in type
2 diabetes, subjects were recruited by third-party patient
recruitment specialists, who used print ads and digital
advertising (i.e., social media). This group facilitated the process
of identifying, scheduling, and forwarding potential participants
to the study’s clinical research coordinators. Entry criteria
included those 50 years of age and older, were overweight
or obese, had type 2 diabetes for more than five years, and
the hemoglobin A1c (HbA1c) was greater than 5.7%. Subjects
provided written informed consent in which they agreed to
regularly test their blood glucose levels and consume five
nutrient-dense, functional foods daily for eight weeks. All data
were self-reported and submitted electronically on to HIPAAprotected
area. Each participant was provided regular coaching
by one of us (NM), which occurred at least weekly to assist with
Subjects were provided five nutrient-dense, portioncontrolled
functional foods daily over two months. Foods were
provided at no charge and were easy-to-prepare; most required
just the addition of hot or cold water or milk. Participants could
choose from a variety of options such as shakes, cold and hot
cereals, food bars, and hot meals (e.g., beans and rice, noodles
and cheese sauce) (http://nutrientfoods.com). Each functional
food contained at least 25% of the Daily Value (DV) for every
vitamin and mineral, except sodium and chloride. At least 25%
Adequate Intakes (AI) for omega-3s were also included in each
offering. Free nutrition coaching was provided to assist with
questions about the dietary intervention and aid compliance.
Each week, the participants reported how many of the five
functional foods they consumed and how much of each.
In addition to consuming the nutrient-dense foods, the
participants were counseled according to American Diabetes
Association guidelines for healthy eating. Recipes that complied
with these guidelines were also provided for using the nutrientdense
Body weight and waist circumference were measured
at baseline and then weight was tracked weekly and waist
measured, monthly. Disease risk for chronic diseases (i.e.,
hypertension, type 2 diabetes, and CVD) was determined from
body weight and waist circumference at baseline and the end of
the study .
At baseline, subjects submitted fasting blood glucose, postprandial
glucose, and HbA1c obtained from their doctor within
the past three months. Once the dietary intervention began, on
two different days each week, participants measured fasting
blood glucose (FBG) after at least an 8-hour overnight fast,
and post-prandial blood glucose after any meal but within 60
minutes of finishing it. Change in HgbA1c and reported as a
percentage was determined by subtracting the week 8 value
from the baseline one.
At baseline and weekly, subjects answered eight questions
about their quality of life. Each was rated using a scale of one
to five, with 5 being the best and 1 being the worst. Questions
probed: general feeling, fullness, mood, energy level, any
gastrointestinal symptoms (GI), sleep quality, appearance, and
overall diet quality. The percentage change between the mean at
baseline and week 8 was calculated.
+Disease Risk for Hypertension, Cardiovascular Disease, and Type 2 Diabetes .
Thirty-four subjects enrolled in the study and 18 completed
it (53%), of which 59% were female (Table 1). At baseline, the
mean age of the participants was 55±8 years, and the body
mass index (BMI) average was 34±4 kg/m2. Only 15% were
classified as being Overweight and the rest had Obesity. Obesity
was further classified according to severity and 14 had the least
severe form (Class I), 11 had moderate obesity (Class II), and
4 had the severest form (Class III). Waist circumference was
at high risk for 57% of men (> 102 cm) and 85% of women (>
88cm). Using both BMI and waist circumference to calculate
disease risk, 2 participants were at Increased risk, 11 had High
risk, 17 were at Very High risk, and 4 had Extremely High risk.
Most participants (47%) consumed three of the nutrientdense
meals daily; only 17% of the consumed four meals and
the same percentage ate five meals daily. About the same (18%)
consumed only about 2.5 meals daily.
Of those who responded to the exercise-related questions
(n=15), eight excised three hours weekly, five exercised four
hours each week, and two did less than two hours weekly, on
average. Most people (9/15) exercised for 30 minutes, but the
range was 20-90 minutes. Favorite activities included walking,
swimming, and spinning.
*Data Presented as Mean±Standard Deviation. P is Estimated Using
Student’s Unpaired t-test.
+Compared to Baseline; P: 0.29 for Weight and P: 0.01 for BMI
^Compared to Baseline; P: 0.23 for Weight and P: 0.003 for BMI
Body weight decreased over the first four weeks by 5 kg
going from 98±18 kg to 93±15 kg and stabilized until the end
with a mean body weight of 92±15 kg (Table 2). Changes in
body weight were not significant over time but represent a 6%
decrease, which is medically significant. BMI declined most
between baseline and week 4 (34±4 to 32±3 kg/m2). At the end,
BMI as nearly the same at week 4 (31±3 k/m2). Compared to
baseline, BMI at week 4 (P = 0.01) and week 8 (P = 0.003) were
Waist circumference decreased for both women (107±13
cm at baseline to 102±15 cm at week 8), and men (110±16 cm
at baseline to 100±11 cm at week 8) (Table 3). The percentage
of women with high risk waist circumferences remained stable
throughout the study at around 85% of the group. Men with high
risk waist circumferences decreased – 57% were at high risk at
baseline and 33% were at week 8.
*Data Presented as Mean±Standard Deviation
Disease risk using BMI and waist circumference were
available for 17 subjects for baseline and week 8. Of these, 4/17
participants experienced a decrease in disease risk (3 males;
1 female), 2/17 increased disease risk (1 male, 1 female), and
13/17 had no change (5 males; 6 females).
Compared to baseline, week 4 fasting blood glucose
concentrations were not significantly lower, but post-prandial
levels were (baseline: 216±72; week 4: 172±54 mg/dL; p =
0.02). By week 8, both fasting blood glucose and post-prandial
concentrations were significantly lower than at baseline. At
baseline, mean fasting blood glucose concentration was 161±49
mg/dL, and at week 8 the mean was 130±25 mg/dL (P = 0.007).
Similarly, the mean post-prandial blood glucose concentration
was 216±72 mg/dL at baseline and decreased to 161±44 mg/dL
at week 8 (P = 0.003) (Table 4).
+P is estimated by Student-Unpaired t-test. The statistical significance
is determined by P < 0.05.
Gender: M: Male; F: Female
+According to the Centers for Disease Control , Hemoglobin A1c
is Defined as: Normal < 5.7%, Pre-diabetes: 5.7% to 6.4%, Diabetes
At baseline (n=33), the mean HgbA1c was 8.6±1.9 %. By
week 8, data were only available for five participants (Table
5). At baseline, these five participants were classified as having
diabetes according to the HgbA1c percentage . At week
8, all experienced a decrease in HgbA1c with three subjects
experiencing a reduction of 1.5%; one had a decrease of 1.7%,
and one decreased 1.8%. At the end based on HgbA1c, one
normalized, one became pre-diabetic, and three continued with
diabetes. Weight loss was not related to percentage decrease in
HgbA1c (data not shown).
Each quality of life attribute improved significantly (P≤0.05)
over the eight weeks, except gastrointestinal symptoms, which
remained unchanged (Table 6). The greatest improvements (>
30%) determined by the percentage increase between week 8
and baseline were observed for: improved diet quality, increased
energy, better sleep, better appearance, and generally feeling
+Rating Scale used was 1 to 5, with 1 being the Worst and 5 being the Best. Data presented as Means±S.D. Statistical significance determined
by Student-Unpaired t-test, p ≤ 0.05.
*Week 4 Compared to Baseline
^Week 8 Compared to Baseline
Type 2 diabetes, like other chronic conditions, is caused
by a poor diet and lifestyles. Participants with type 2 diabetes
in this study stated that they wanted to eat better, and agreed
to consume five, healthy nutrient-dense, easy-to-use, portioncontrolled,
functional foods for eight weeks. Use of five of these
meals daily was shown to promote weight loss in overweight
subjects, who did not have type 2 diabetes [16,17].
Most of the participants in this study ate an average of
three meals daily, and still experienced a 6% weight loss
and a significant decrease in BMI by week 8 (P = 0.003).
More importantly was that glucose management improved,
exemplified by significant decreases in fasting blood glucose and
post-prandial levels (P < 0.05). In addition, the five subjects who
provided HgbA1c data at the beginning and end of the study,
experienced decreases that exceeded what would be expected
from oral antidiabetic agents. quality of life indicators . The
participants had decreases over eight weeks of HgbA1c of 1.5%
to 1.8%; oral agents typically reduce it by 0.5% to 1.25% after
The participants found incorporation of nutrient-dense,
portion-controlled, functional foods into their lives fairly easy,
but regular nutritional counseling was required to assure
compliance. One of us (NM) had at least weekly contact with
the participants and shared ideas how to prepare the nutrientdense
meals and what else to eat. The participants that
completed the study were pleased with their results and had
significant improvements in all quality of life indicators except
gastrointestinal symptoms, which did not change.
One limitation of the study is the self-reporting of data, but
it is customary for patients with type 2 diabetes to monitor
their blood glucose levels and report their readings to their
physicians. Admittedly the drop-out rate was high and seems
to be related to the difficulty of people with type 2 diabetes to
change their diets. However, those that remained benefited in
a variety of ways including weight loss, glycemic management,
and quality of life.
The diet of patients with type 2 diabetes is nutrient-poor
and rich in harmful additives like salt, sugar, and saturated fats,
making management of the condition difficult. Inclusion of up
to five, nutrient-dense, functional foods that are low harmful
additives was beneficial to these patients by significantly
improving glycemic control, both for fasting blood glucose and
post-prandial concentrations. The decrease in HgbA1c exceeded
what would have been expected from oral antidiabetic agents.
These improvements were coupled with a 6% weight loss and
decreases in waist circumference. New dietary strategies are
needed for patients with type 2 diabetes and nutrient-dense,
functional foods may be a good option.
The authors are grateful to the participants who dutifully
completed their weekly data collections forms and carefully
monitored their blood glucose levels. It is difficult to change one’s diet, but these patients with type 2 diabetes did and were
pleased with the results.
Nicholas Morehouse oversaw this study in partial fulfillment
of a Master of Science degree. Dr. Ling was the statistical
consultant. The other co-authors are full-time employees at
Nutrient, the company that manufactures and sell the nutrientdense
functional foods used in this study.