"Effect of High Fat and High Glycemic Diets

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01494935
Collaborator
(none)
24
1
2
105
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High Glycemic Diet
  • Behavioral: Control diet
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
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
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Insulin Sensitivity [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

  1. ceramides and diacylglycerol [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
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

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55975

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Sreekumaran Nair, MD, Ph.D, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
K. Sreekumaran Nair, MD, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01494935
Other Study ID Numbers:
  • 10-005948
First Posted:
Dec 19, 2011
Last Update Posted:
Feb 5, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Feb 5, 2020