"Effect of High Fat and High Glycemic Diets

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
K. Sreekumaran Nair, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01494935
First received: November 18, 2011
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: Measured at day 0 (baseline) and day 10 (of high fat meals) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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: December 2014
Estimated Primary Completion Date: December 2014 (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
NORMAL FAT AND GLYCEMIC DIET CONSUMED High FAT AND Glycemic Diet consumed

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01494935

Contacts
Contact: Sreekumaran Nair, MD, PhD. 507-255-2949 nair@mayo.edu

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

No publications provided

Responsible Party: K. Sreekumaran Nair, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01494935     History of Changes
Other Study ID Numbers: 10-005948
Study First Received: November 18, 2011
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014