NCT04051190

Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite

Effects of Diet-induced Weight Loss Versus Sleeve Gastrectomy and Gastric Bypass on Homeostatic and Hedonic Appetite Markers and Gut Microbiota

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The biggest challenge in obesity management is maintaining weight loss in the long-term. Currently, bariatric surgery is the most effective treatment, leading to sustained weight loss that is not yet achievable with lifestyle intervention (e.g. diet). The reasons behind its success is still not clearly understood, but beneficial changes in the homeostatic and hedonic appetite systems (the two major physiological regulators of appetite), along with the microbiome (known to have a mediatory effect on appetite) have been shown to occur after bariatric surgery. These alterations are in opposition to what is seen after diet-induced weight loss. Today, the component of appetite regulation that drives bariatric surgeys' long-term success is still unknown. By comparing a lifestyle and surgical intervention in parallel, the investigators can observe the impact of a similar magnitude of weight loss on these three domains of appetite regulation simultaneously, thereby illuminating the mechanisms behind bariatric surgerys' success.

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	VLED group	10-week weight loss period with total meal replacement, consisting of 750 kcal/day. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and at 1 year.
PROCEDURE	Sleeve Gastrectomy group	Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (sleeve gastrectomy)
PROCEDURE	Gastric Bypass group	Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (gastric bypass)

Timeline

• Start date: 2019-09-02
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-08-09
• Last updated: 2023-07-25

Locations

2 sites across 1 country: Norway