A Study of the Effect of Orange Juice or Sugar-Sweetened Beverages on Risk Factors for Type 2 Diabetes and Cardiovascular Disease

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"In this study, the study team will provide meals and either sugar-sweetened beverages or orange juice."
Age: 18 to 50 years old
Gender:
Any
Healthy Volunteers: Yes
Keywords: type 2 diabetse, insulin sensitivity, cardiovascular risk factor, metabolic syndrome
Type: Other study
Target:
72 Participants
Investigator:
Description
In this study, we hope to learn more about the effects of drinking sugar-sweetened beverages or orange juice. The beverages will be given with meals that we provide. Therefore, we will know exactly what the meals consists of.

The study team will provide meals and either sugar-sweetened beverages or orange juice. We will compare the effects that the beverages have on blood triglyceride and cholesterol levels. We will look at your body’s reaction to insulin (hormone which lowers blood sugar).
This study requires

You will be asked to have the following “screening” exams, tests or procedures to find out if you can be in the study.

When the study starts, you will take part in the following dietary protocol, tests and procedures:

DIETARY PROTOCOL:

  • Standardized diet: You will eat only the study food provided during the entire 7-weeks of the study. You will not be allowed to eat non-study foods. You will receive a standardized diet consisting of a breakfast, lunch, dinner and snack that you will need to adhere to this diet plan. The amount of food provided is based on your calculated energy requirement. This is a standard calculation used for all subjects, so it is important to report to the study staff if you feel that you are being provided with too much or too little food. There will be specific meals provided to you the day before or day of a scheduled procedure that must be eaten in full. This is necessary in order for this study to produce scientifically accurate information. If giving up all of your favorite foods and drinks for 7 weeks is something that you are not willing to do, this study is not suitable for you.

  • Sugar-sweetened or naturally-sweetened beverages:You will be restricted to drinking only water, black coffee (if applicable) and the study beverages provided during the entire 7-weeks of the study. You will be restricted from drinking outside beverages, including alcohol (except water and black coffee).

  • Intervention: Upon completion of all the initial baseline procedures, for the last 5 weeks of the study, you will drink sweetened beverages. These beverages will be provided to you as 3 servings/day, approximately 12-16 fluid ounces/serving, and are to be consumed one at each meal.You will be provided with beverages that contain either sugar or orange juice. In order for this study to produce scientifically useful information, it is necessary that you consume all 3 of the beverages provided each day for the last 5 weeks of the study. The sweetened beverage that you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what beverage you get. You will have a one in two chance of being given a sugar-sweetened beverage.
Who can participate

Inclusion criteria:

  • Men and pre-menopausal women
  • Body mass index: 20-35 kg/m2
  • Body weight >than 50 kg
  • Self-reported stable body weight during the prior six months

Exclusion criteria:

  • Fasting glucose >125 mg/dl Evidence of liver disorder (AST or ALT >200% upper limit of normal range)
  • Evidence of kidney disorder (>2.0 mg/dl creatinine)
  • Evidence of thyroid disorder (out of normal range)
  • Systolic blood pressure consistently over 140 mmHg or diastolic blood pressure over 90 mmHg Triglycerides > 400 mg/dl LDL-C > 160 mg/dl in combination with Chol:HDL > 4 Hemoglobin < 10 g/dL
  • Pregnant or lactating women
  • Current,prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents.
  • Use of thyroid, anti-hypertensive, anti-depressant, weight loss medications or any other medication which, in the opinion of the investigator, may confound study results
  • Use of tobacco Strenuous exerciser (>3.5 hours/week at a level more vigorous than walking)
  • Surgery for weight loss Diet exclusions: Food allergies, special dietary restrictions, routine consumption of less than 3 meals/day, routine ingestion of more than 2 sugar-sweetened beverages or 1 alcoholic beverage/day, unwillingness to consume any food on study menu
  • Veins that are assessed by the R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter. -Pre-existing claustrophobia or metal implants that preclude magnetic resonance imaging
  • Any other condition that, in the opinion of the investigators, would put the subject at risk
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $900 for your time and effort.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for approximately 45-49 days. It may exceed 49 days if schedule adjustments have to be made to accommodate unforeseen problems.
Recruitment period
From Jan. 9, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Kimber Stanhope
Research Topic
Conditions:
  • Cardiovascular Risk Factor
  • Type2 Diabetes Mellitus
  • Insulin Sensitivity
  • Metabolic Syndrome

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


Sending

Send SMS with Study Info:

SMS Sent!

Share Study Info via Email:


E-mail Preview