Functional Snack Foods With Safflower Oil and Soy in Postmenopausal Women Having Metabolic Syndrome
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 45 - 70 |
| Updated: | 8/23/2018 |
| Start Date: | July 2014 |
| End Date: | December 2020 |
Evaluation of Functional Snack Foods Containing Safflower Oil and Soy on Endpoints of Energy Metabolism in Postmenopausal Women With Metabolic Syndrome
This research study is being done to help researchers develop new dietary options for
menopausal women to maintain a healthy weight by developing more nutritious snacks that have
health benefits. From this study, the researchers hope to gain understanding on how
menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its
own and when combined with soy. The research team hypothesize that the two different types of
pretzels may be processed by your body differently and that components in the pretzel snacks
may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans
contain many natural chemicals that may benefit human health. However, this relationship is
not well understood. This study will look at the impact of the pretzel snacks on your blood
fat and glucose levels as well as a group of chemicals found in soy called "isoflavones".
Isoflavones are natural chemicals found commonly in soybeans or foods made from them.
Participants will be screened to determine if they qualify in meeting the study requirements.
Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein.
Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts
and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The
study will require five visits to the Ohio State University Clinical Research Center (CRC)
which part of the Ohio State University's Center for Clinical and Translational Sciences.
Once the investigators have determined that you qualify for this study and you decide to
participate, you will be consuming three different pretzels each for one month, starting with
a control pretzel. After the control pretzel treatment period, you will be randomly assigned
(like the "flip of a coin") to start with one of the two pretzel groups (wheat or soy pretzel
with safflower oil) for your first treatment period and then switch to the other safflower
oil pretzel at your second treatment period.
menopausal women to maintain a healthy weight by developing more nutritious snacks that have
health benefits. From this study, the researchers hope to gain understanding on how
menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its
own and when combined with soy. The research team hypothesize that the two different types of
pretzels may be processed by your body differently and that components in the pretzel snacks
may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans
contain many natural chemicals that may benefit human health. However, this relationship is
not well understood. This study will look at the impact of the pretzel snacks on your blood
fat and glucose levels as well as a group of chemicals found in soy called "isoflavones".
Isoflavones are natural chemicals found commonly in soybeans or foods made from them.
Participants will be screened to determine if they qualify in meeting the study requirements.
Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein.
Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts
and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The
study will require five visits to the Ohio State University Clinical Research Center (CRC)
which part of the Ohio State University's Center for Clinical and Translational Sciences.
Once the investigators have determined that you qualify for this study and you decide to
participate, you will be consuming three different pretzels each for one month, starting with
a control pretzel. After the control pretzel treatment period, you will be randomly assigned
(like the "flip of a coin") to start with one of the two pretzel groups (wheat or soy pretzel
with safflower oil) for your first treatment period and then switch to the other safflower
oil pretzel at your second treatment period.
The overarching goal is to develop new dietary strategies to help postmenopausal women
maintain a healthy weight by improving the availability of nutritious snacks that contain
added health benefits and will be used to assess the impact of a functional snack on snacking
behavior. The primary objective is to evaluate safflower oil delivered in a wheat pretzel
compared to a wheat pretzel enhanced with soy will have a greater affect on blood
triglyceride and glucose levels thereby affecting satiety and snacking behavior. The
investigators hypothesize that a functional snack food such as a soft pretzel containing
safflower oil either with or without soy compared to the control pretzel (wheat pretzel with
no safflower oil) will reduce postprandial blood triglycerides and glucose.
This proposed multidisciplinary study is a randomized cross-over trial involving 20
overweight (BMI > 25 kg/m2) postmenopausal women with metabolic syndrome will participate in
a dietary intervention study for a total of 14 weeks (two weeks of washout and three 4 week
interventions). The study will require five visits to the Ohio State University Clinical
Research Center (CRC), part of the Center for Clinical and Translational Sciences, Figure 5.
Women will visit the CRC to be screened (Day-14) and their eligibility will be determined
using a health and lifestyle questionnaire and results from a 12 hour fasting lipid panel
(total cholesterol, LDL, HDL, triglycerides). Those meeting the National Cholesterol
Education Program criteria for metabolic syndrome and having no other excluding conditions
will be enrolled. Prior to their oral triglyceride tolerance tests (OTTT), women will be
instructed to abstain from a. alcohol consumption for 72 hour, b. consume ≥150g of
carbohydrates for 24 hours, c. abstain from vigorous exercise for 24 hours, d. collect urine
for 24 hours, e. fast for 12 hours prior to all their clinic visits. When women arrive at the
CRC for their clinic visits, weight and vital signs will be collected and a venous catheter
placed for timed blood collections. Blood will be collected for serum triglycerides and
glucose prior to (-5 minutes) and at 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes
after consumption of the test meal. At their run-in visit (Day 0), subjects will consume a
control pretzel with a flavored oil dip containing a standardized quantity of triglycerides
(50 g long chain fatty acids). At the first treatment period (Day 28) visit, women will be
randomized to one of the two intervention groups (wheat or soy pretzel with safflower oil)
and then crossover to the other safflower oil pretzel at their second treatment period visit
(Day 56). The two intervention pretzel meals will be accompanied with the same oil dip
provided before. At the end of each OTTT visit women will be instructed to continue eating
the test pretzels (12 pretzel bites/day) for the next 28 days as a snack. Subjects will be
instructed to complete questions pertaining to their satiety during their 7 hour stay. Women
will return for their last visit on Day 84 to submit all completed study materials (survey,
dietary recall, and daily intake journal), completed 24 hour urine collection, and blood
collection.
maintain a healthy weight by improving the availability of nutritious snacks that contain
added health benefits and will be used to assess the impact of a functional snack on snacking
behavior. The primary objective is to evaluate safflower oil delivered in a wheat pretzel
compared to a wheat pretzel enhanced with soy will have a greater affect on blood
triglyceride and glucose levels thereby affecting satiety and snacking behavior. The
investigators hypothesize that a functional snack food such as a soft pretzel containing
safflower oil either with or without soy compared to the control pretzel (wheat pretzel with
no safflower oil) will reduce postprandial blood triglycerides and glucose.
This proposed multidisciplinary study is a randomized cross-over trial involving 20
overweight (BMI > 25 kg/m2) postmenopausal women with metabolic syndrome will participate in
a dietary intervention study for a total of 14 weeks (two weeks of washout and three 4 week
interventions). The study will require five visits to the Ohio State University Clinical
Research Center (CRC), part of the Center for Clinical and Translational Sciences, Figure 5.
Women will visit the CRC to be screened (Day-14) and their eligibility will be determined
using a health and lifestyle questionnaire and results from a 12 hour fasting lipid panel
(total cholesterol, LDL, HDL, triglycerides). Those meeting the National Cholesterol
Education Program criteria for metabolic syndrome and having no other excluding conditions
will be enrolled. Prior to their oral triglyceride tolerance tests (OTTT), women will be
instructed to abstain from a. alcohol consumption for 72 hour, b. consume ≥150g of
carbohydrates for 24 hours, c. abstain from vigorous exercise for 24 hours, d. collect urine
for 24 hours, e. fast for 12 hours prior to all their clinic visits. When women arrive at the
CRC for their clinic visits, weight and vital signs will be collected and a venous catheter
placed for timed blood collections. Blood will be collected for serum triglycerides and
glucose prior to (-5 minutes) and at 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes
after consumption of the test meal. At their run-in visit (Day 0), subjects will consume a
control pretzel with a flavored oil dip containing a standardized quantity of triglycerides
(50 g long chain fatty acids). At the first treatment period (Day 28) visit, women will be
randomized to one of the two intervention groups (wheat or soy pretzel with safflower oil)
and then crossover to the other safflower oil pretzel at their second treatment period visit
(Day 56). The two intervention pretzel meals will be accompanied with the same oil dip
provided before. At the end of each OTTT visit women will be instructed to continue eating
the test pretzels (12 pretzel bites/day) for the next 28 days as a snack. Subjects will be
instructed to complete questions pertaining to their satiety during their 7 hour stay. Women
will return for their last visit on Day 84 to submit all completed study materials (survey,
dietary recall, and daily intake journal), completed 24 hour urine collection, and blood
collection.
Inclusion Criteria:
- Postmenopausal women 45 to 70 years of age
- Stated to be postmenopausal and has a cessation of menstruation for greater than 12
months
- Have a body mass index ≥25 kg/m2
- Must meet three of the five following criteria12
1. Have a waist circumference greater than 35 inches
2. Fasting serum triglycerides of greater than 150 mg/dL
3. Fasting high density lipoprotein (HDL) less than 40 mg/dL
4. Fasting blood glucose greater than 100 mg/dL
5. Systolic blood pressure greater than 130 mm Hg or diastolic blood pressure
greater than 85 mm Hg
- Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition
and alternative supplements for the duration of the study
- Agree to follow a legume free diet and to document any accidental consumption of
restricted foods each day of the study
Exclusion Criteria:
- Have an active metabolic or digestive illness including malabsorptive disorders, renal
insufficiency, hepatic insufficiency, or had recent (within the year) gastrointestinal
surgery.
- Have a history or have active hormone related diseases of the pituitary, thyroid or
pancreas that currently require supplemental hormonal administration thyroid hormones,
adrenocorticotropic hormone (ACTH), growth hormone or other endocrine disorders
requiring hormone or insulin administration
- Have an active or a recent history of any condition that causes altered immunity such
as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood
dyscrasias
- Are on cholesterol lowering medications which include but not limited to statins,
niacin (vitamin B3), bile-acid resins, fibric acid derivatives, or cholesterol
absorption inhibitors.
- Have a known allergy or food intolerance to ingredients in study products (wheat, soy,
or safflower oil)
- Are strict vegans (no consumption of animal, fish or egg products)
- Are heavy alcohol consumers (defined as an average consumption of greater than 14
drinks/week)
- Have a history of cancer or currently undergoing treatment for cancer
- Have been on an antibiotic regime lasting for more than one week in the last 6 months
- Are currently on another study for weight loss or trying to actively lose weight or
recently (last 3 months) started medications for weight loss.
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