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Dietary Supplement
Dairy Fat for Obesity
N/A
Waitlist Available
Led By Bruce Hammock, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Central obesity (waist circumference greater than 40 inches for men and 35 inches for women); fasting blood triglycerides greater than or equal to 150 mg/dL; plasma HDL cholesterol (Less than 40 mg/dL for men and less than 50 mg/dL for women); blood pressure greater than or equal to 130/85 mmHg; fasting glucose greater than or equal to 100 mg/dL
Two or more components of metabolic syndrome: Central obesity, fasting blood triglycerides, plasma HDL cholesterol, blood pressure, fasting glucose, or BMI equal to or greater than 30
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 0 hour up to 6 hours postprandial
Awards & highlights
Study Summary
This trial is studying the effects of dairy fat on postprandial inflammation in people with obesity or metabolic syndrome.
Who is the study for?
Adults aged 18-65 with metabolic syndrome or obesity, defined by specific criteria such as waist size, blood fat levels, and blood pressure. Excluded are pregnant women, heavy drinkers, those on certain medications or with gastrointestinal disorders, extreme obesity (BMI >40), recent significant weight changes or dietary shifts.Check my eligibility
What is being tested?
The study is testing how different types of fats affect inflammation in people with metabolic issues after eating a high-fat meal. It compares the effects of dairy fat rich in milk fat globule membrane (MFGM) to palm fat over six hours.See study design
What are the potential side effects?
Since this trial involves consumption of dietary fats rather than medication, side effects may include digestive discomfort or changes in energy levels. However, detailed potential side effects related to consuming these specific fats aren't provided.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a large waist, high triglycerides, low HDL cholesterol, high blood pressure, or high blood sugar.
Select...
I have at least two symptoms of metabolic syndrome.
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I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from 0 hour up to 6 hours postprandial
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 0 hour up to 6 hours postprandial
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasma inflammatory mediators
Secondary outcome measures
Tumor Markers
Plasma glucose
Plasma lipid profile
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Palm fat + MFGMExperimental Treatment1 Intervention
The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain palm fat, frozen fruit, glucose polymer, and BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids. Fifty percent of the shake's fat will be derived from BPC50.
Group II: Dairy fat + MFGMExperimental Treatment1 Intervention
The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain whipping cream, frozen fruit, glucose polymer, and BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids. Fifty percent of the shake's fat will be derived from BPC50.
Group III: Palm fatActive Control1 Intervention
The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain palm fat, frozen fruit, glucose polymer, and protein powder.
Group IV: Dairy fatActive Control1 Intervention
The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain whipping cream, frozen fruit, glucose polymer, and protein powder.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,953 Total Patients Enrolled
12 Trials studying Metabolic Syndrome
634 Patients Enrolled for Metabolic Syndrome
Dairy Research InstituteOTHER
17 Previous Clinical Trials
973 Total Patients Enrolled
4 Trials studying Metabolic Syndrome
252 Patients Enrolled for Metabolic Syndrome
Bruce Hammock, PhDPrincipal InvestigatorUC Davis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a smoker or use other tobacco products.You weigh more than 400 pounds.You have a large waist, high triglycerides, low HDL cholesterol, high blood pressure, or high blood sugar.I have been diagnosed with cancer.I have not used over-the-counter weight loss drugs in the last 3 months.I started taking statin medication within the last 3 months.I have at least two symptoms of metabolic syndrome.I have not used corticosteroid medications in the last 12 weeks.I am not taking supplements like soy isoflavones or resveratrol.I use anti-inflammatory pain medication every day.I have lost or gained more than 10% of my weight in the last 6 months.Your daily diet contains more than 1% of trans fats.You have reported having an eating disorder.You drink more than 2 standard alcoholic drinks every day.I have Type II diabetes.You don't eat eggs, dairy, chicken, beef, or pork.Your diet has too much omega-6 compared to omega-3 fatty acids.My BMI is over 40.You eat more than 14 grams of fiber per 1000 calories per day.I am between 18 and 65 years old.I do not have any major liver or kidney diseases.You started or stopped using hormonal birth control or changed your birth control method in the last 12 weeks.Your veins are not suitable for drawing blood, as determined by a healthcare professional.I have a gastrointestinal disorder such as Crohn's, colitis, or celiac disease.You started a new exercise program within the last 4 weeks.I have an immune-related condition like autoimmune disease or asthma.I started taking anti-inflammatory fish or plant oils in the last 3 months.You eat fish more than once a week.You have a body mass index (BMI) of 30 or higher.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Palm fat
- Group 2: Palm fat + MFGM
- Group 3: Dairy fat
- Group 4: Dairy fat + MFGM
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experimental protocol accept participants aged 18 or older?
"This clinical trial is seeking participants aged 18-65 years old."
Answered by AI
Are there any openings to participate in this experiment?
"Based on the information provided by clinicaltrials.gov, this study is no longer recruiting participants. After originally being posted in August 2013 and last edited September 2022, there are currently 1392 other studies actively looking for patients."
Answered by AI
Is there an opportunity for me to join this experiment?
"In order to qualify for the trial, potential volunteers must be within the age bracket of 18 and 65 years old with a BMI above 30. The research team is hoping to recruit 38 participants in total."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
USDA Western Human Nutrition Research Center
What portion of applicants met pre-screening criteria?
Met criteria
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