Status:
ACTIVE_NOT_RECRUITING
Functional Snack Foods With Safflower Oil and Soy in Postmenopausal Women Having Metabolic Syndrome
Lead Sponsor:
Ohio State University
Conditions:
Metabolic Syndrome
Overweight
Eligibility:
FEMALE
45-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- Have a waist circumference greater than 35 inches
- Fasting serum triglycerides of greater than 150 mg/dL
- Fasting high density lipoprotein (HDL) less than 40 mg/dL
- Fasting blood glucose greater than 100 mg/dL
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02199054
Start Date
July 1 2014
End Date
December 1 2025
Last Update
February 17 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center Clinical Research Center
Columbus, Ohio, United States, 43210