Complex Effects of Dietary Manipulation on Metabolic Function, Inflammation and Health

NAActive, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

November 30, 2027

Study Completion Date

December 31, 2027

Conditions
ObesityInsulin Resistance
Interventions
OTHER

Metabolically abnormal obese - Mediterranean diet

The effect of consuming a Mediterranean diet will be examined over 3 different phases: (i) weight maintenance for 4 to 8 weeks, with all meals provided; (ii) controlled 7-10% weight loss with caloric intake reduced by 25% to achieve the desired amount of weight loss in about 4 to 5 months with all meals provided; and (iii) Independent weight loss for about 4 months. During the independent weight loss phase of the study subjects will be asked to continue to consume a Mediterranean diet but will prepare all their food at home. No food will be provided during this portion of the study.

OTHER

Metabolically abnormal obese - Low carbohydrate ketogenic diet

The effect of consuming a low-carbohydrate, ketogenic diet will be examined over 3 different phases: (i) weight maintenance for 4 to 8 weeks, with all meals provided; (ii) controlled 7-10% weight loss with caloric intake reduced by 25% to achieve the desired amount of weight loss in about 4 to 5 months with all meals provided; and (iii) Independent weight loss for about 4 months. During the independent weight loss phase of the study subjects will be asked to continue to consume a low carbohydrate ketogenic diet but will prepare all their food at home. No food will be provided during this portion of the study.

OTHER

Metabolically abnormal obese - Plant-based, very-low-fat diet

The effect of consuming a plant-based, very-low-fat diet will be examined over 3 different phases: (i) weight maintenance for 4 to 8 weeks, with all meals provided; (ii) controlled 7-10% weight loss with caloric intake reduced by 25% to achieve the desired amount of weight loss in about 4 to 5 months with all meals provided; and (iii) Independent weight loss for about 4 months. During the independent weight loss phase of the study subjects will be asked to continue to consume a plant-based, very-low-fat diet but will prepare all their food at home. No food will be provided during this portion of the study.

BEHAVIORAL

Annual Follow-up Visits

Metabolic health will be assessed 1 and 2-years after competing the diet intervention study. No intervention will be performed during the time.

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

All Listed Sponsors
lead

Washington University School of Medicine

OTHER

NCT02706262 - Complex Effects of Dietary Manipulation on Metabolic Function, Inflammation and Health | Biotech Hunter | Biotech Hunter