- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01494935
"Effect of High Fat and High Glycemic Diets
February 4, 2020 updated by: K. Sreekumaran Nair, Mayo Clinic
Effect of High Fat and High Glycemic Diets on Muscle Protein Synthesis in Somali Immigrants and Americans of Northern European Descent
The investigators will determine whether people with high muscle mitochondrial capacity produce higher amount of reactive oxygen species (ROS) on consuming high fat /high glycemic diet and thus exhibit elevated cellular oxidative damage.
The investigators previously found that Asian Indian immigrants have high mitochondrial capacity in spite of severe insulin resistance.
Somalians are another new immigrant population with rapidly increasing prevalence of diabetes.
Both of these groups traditionally consume low caloric density diets, and the investigators hypothesize that when these groups are exposed to high-calorie Western diets, they exhibit increased oxidative stress, oxidative damage, and insulin resistance.
The investigators will compare Somalians and NE Americans who are matched for age, BMI, and sex.
The investigators will measure ROS production in skeletal muscle following high fat/high glycemic diet vs. healthy diet.
The investigators will compare the oxidative damage to proteins, DNA, and lipids in these two populations following 10 days of high fat/high glycemic index diet in comparison with low fat diet.
The investigators will determine if elevated levels of oxidative damage in Somali immigrant populations is accompanied by high mitochondrial capacity, higher ROS-emitting potential, and lower insulin sensitivity than NE.
The proposed study will be performed utilizing the state-of-the-art proteomic and metabolomic methods many of which were recently developed in our laboratory.
The investigators expect the results from this study to provide seminal insights into the underlying mechanism of insulin resistance and type 2 diabetes, in addition to demonstrating mechanisms by which a functional proteome is maintained in vivo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55975
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Somali immigrants age 40-65,
- BMI 23-34 kg/m2,
- sedentary (exercise less than 2 days per week for less than 20 minutes).
Inclusion criteria:
- for Northern European descendants same as for Somali immigrants plus need to match a Somali immigrant for age, BMI and habitual activity.
Exclusion Criteria:
- Triglycerides on screening examination of greater than 300;
- pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Normal glycemic diet
COntrol diet with fat and glycemic index similar to typical American diet.
|
Normal fat, normal fat diet
|
|
Experimental: High-fat, high-glycemic diet
|
NORMAL FAT AND GLYCEMIC DIET CONSUMED High FAT AND Glycemic Diet consumed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin Sensitivity
Time Frame: Measured at day 0 (baseline) and day 10 (of high fat meals)
|
The investigators will determine the change from baseline in insulin sensitivity using a hyperinsulinemic euglycemic clamp.
Measurments will be performed at baseline and following 10 days of exercise a high fat diet.
|
Measured at day 0 (baseline) and day 10 (of high fat meals)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ceramides and diacylglycerol
Time Frame: Measured at day 0 (baseline) and day 10 (of high fat meals)
|
The investigators will determine the change from baseline in skeletal insulin ceramide and diacylglycerol concentrations.
Measurments will be performed at baseline and following 10 days of exercise a high fat diet.
|
Measured at day 0 (baseline) and day 10 (of high fat meals)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sreekumaran Nair, MD, Ph.D, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
November 1, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
November 18, 2011
First Submitted That Met QC Criteria
December 15, 2011
First Posted (Estimate)
December 19, 2011
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 4, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 10-005948
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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