This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

"Effect of High Fat and High Glycemic Diets

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by K. Sreekumaran Nair, Mayo Clinic
Information provided by (Responsible Party):
K. Sreekumaran Nair, Mayo Clinic Identifier:
First received: November 18, 2011
Last updated: August 31, 2017
Last verified: August 2017
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.

Condition Intervention
Type 2 Diabetes Behavioral: High Glycemic Diet Behavioral: Control diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of High Fat and High Glycemic Diets on Muscle Protein Synthesis in Somali Immigrants and Americans of Northern European Descent

Further study details as provided by K. Sreekumaran Nair, Mayo Clinic:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 24
Study Start Date: April 2011
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal glycemic diet
COntrol diet with fat and glycemic index similar to typical American diet.
Behavioral: Control diet
Normal fat, normal fat diet
Experimental: High-fat, high-glycemic diet
High-fat, high-glycemic diet
Behavioral: High Glycemic Diet


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01494935

Contact: Sreekumaran Nair, MD, PhD. 507-255-2949

United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55975
Contact: Sreekumaran Nair, MD, Ph.D    507-255-2949   
Principal Investigator: Sreekumaran Nair, MD, Ph.D         
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Sreekumaran Nair, MD, Ph.D Mayo Clinic
  More Information

Responsible Party: K. Sreekumaran Nair, MD, Mayo Clinic Identifier: NCT01494935     History of Changes
Other Study ID Numbers: 10-005948
Study First Received: November 18, 2011
Last Updated: August 31, 2017 processed this record on September 21, 2017