Functional Snack Foods With Safflower Oil and Soy in Postmenopausal Women Having Metabolic Syndrome

NCT02199054 | Active Not Recruiting DMC

• 2 other identifiers: 2014H00452013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Metabolic Syndrome; Overweight

Keywords

Snack Foods; Safflower Oil; Soy; Postmenopausal women; Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Number of Participants having Serious and Non-serious Adverse Events.

  Standardized qualitative and quantitative toxicity criteria (NIH) will be employed to evaluate safety and toxicity of daily safflower oil consumption.

  Up to 3 months

• Number of Participants with 80% Adherence to Safflower Oil Pretzels

  The daily consumption of safflower oil pretzels with and without soy will be assessed with a daily dietary intake journal as well as with measures of isoflavone and linoleic acid metabolites in urine and blood, respectively.

  Up to 3 months

Secondary Outcomes (2)

• Number of Participants with Improved Satiety Visual Analogue Scale (VAS) with Safflower Oil Pretzel Snacks Compared to Control Pretzels.

  Up to 3 months

• Area Under the Concentration-Time Curve for Serum Triglyceride and Glucose

  Before test meal, 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes after the test meal on Days 0, 28, and 56

Other Outcomes (2)

• Identify Number of Participants with Changes in Blood Gene Expression from Day 0 Compared to Day 84.

  Up to 3 months

• Isoflavone Metabolite Profile Collected from Urine on Days 0, 28, 56, and 84

  Up to 3 months

Study Arms (3)

Run-in Intervention

PLACEBO COMPARATOR

Control wheat pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of control wheat pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.

Other: control wheat pretzels

Wheat-Safflower Oil Arm

ACTIVE COMPARATOR

Wheat-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of wheat-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.

Other: wheat-safflower oil pretzels

Soy-Safflower Oil Arm

ACTIVE COMPARATOR

Soy-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of soy-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.

Other: soy-safflower oil pretzels

Interventions

wheat-safflower oil pretzels OTHER

Each serving (6 pieces) of the wheat-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, safflower oil, sugar, yeast, salt, and ascorbic acid.

Wheat-Safflower Oil Arm

soy-safflower oil pretzels OTHER

Each serving (6 pieces) of the soy-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, soy flour, soymilk, safflower oil, sugar, yeast, salt, and ascorbic acid.

Soy-Safflower Oil Arm

control wheat pretzels OTHER

Each serving (6 pieces) of the control wheat pretzel contains 6 grams of vegetable shortening. Ingredients in the pretzel are high gluten wheat flour, vegetable shortening, sugar, yeast, salt, and ascorbic acid.

Run-in Intervention

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center Clinical Research Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Overweight

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yael Vodovotz, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2014
• First Posted: July 24, 2014
• Study Start: July 1, 2014
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 10, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)