"Effect of High Fat and High Glycemic Diets

NCT ID: NCT01494935

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2019-12-31

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Normal glycemic diet

COntrol diet with fat and glycemic index similar to typical American diet.

Group Type: EXPERIMENTAL

Control diet

Intervention Type: BEHAVIORAL

Normal fat, normal fat diet

High-fat, high-glycemic diet

High-fat, high-glycemic diet

Group Type: EXPERIMENTAL

High Glycemic Diet

Intervention Type: BEHAVIORAL

NORMAL FAT AND GLYCEMIC DIET CONSUMED High FAT AND Glycemic Diet consumed

Interventions

High Glycemic Diet

NORMAL FAT AND GLYCEMIC DIET CONSUMED High FAT AND Glycemic Diet consumed

Intervention Type: BEHAVIORAL

Control diet

Normal fat, normal fat diet

Intervention Type: BEHAVIORAL

Eligibility 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).

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

K. Sreekumaran Nair

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sreekumaran Nair, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

10-005948

Identifier Type: -

Identifier Source: org_study_id