NCT04884659

Time-Restricted Feeding

The Impact of Time-Restricted Feeding on Metabolism and Inflammation in Obesity (TRIO Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

We propose to conduct a randomized 6-day isocaloric crossover feeding study in humans with prediabetes and obesity. We will study the effect of restricting the timing of caloric intake to earlier in the day (TRF) versus later in the day (usual feeding pattern, UFP) on glycemia and inflammation in an inpatient setting.

Detailed description

Time Restricted Feeding (TRF) is a variant of intermittent fasting that confines caloric intake to active daytime hours and involves fasting for 12 to 14 hours. Circadian misalignment caused by changes in sleeping and eating behaviors has emerged as having a detrimental impact on weight, glucose homeostasis and other cardiovascular disease-related outcomes. Feeding during active periods appears to be advantageous for weight, glucose metabolism and lipid profiles whereas feeding during the inactive period confers deleterious effects on these outcomes. Therefore, TRF shows great promise as a novel intervention for addressing obesity and related cardiovascular outcomes. Animal studies suggest that timing of feeding, including intermittent fasting or TRF, decreases inflammation and causes ketosis. Human studies that examined time restricted feeding for improvement in glycemia in as little as 4 days did not observe changes in clinical markers of inflammarion such as hsCRP. Moreover, systemic and adipose tissue inflammation as it occurs in obesity shows dynamic changes in the context of weight loss that would not be clearly apparent in a weight stable state. A potential mechanistic link between glycemic improvement and systemic inflammation would be the Receptor for Advanced Glycation End-Products (RAGE) and its soluble form (sRAGE).This form of inflammation has not been measured in reported eTRF studies and its relationship with eTRFwould bea significant contribution from the proposed study.

Conditions

• Obesity
• Inflammatory Markers
• Glycemic Variation
• Time Restricted Feeding
• Ketosis

Interventions

Type	Name	Description
OTHER	Time restricted feeding arm	80% of calories consumed before 2PM, remaining 20% consumed by 4PM. Fasting for 14-16 hours
OTHER	usual feeding pattern arm	All meals consumed ad lib with 50% of calories consumed after 4PM

Timeline

• Start date: 2021-06-10
• Primary completion: 2022-08-15
• Completion: 2022-08-15
• First posted: 2021-05-13
• Last updated: 2022-08-24

Locations

1 site across 1 country: United States