NCT05354245

Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)

Using a Complex Carbohydrate Mixture Added to a High-protein Diet to Steer Fermentation and Improve Metabolic, Gut and Brain Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the effects of a fibre mixture added to a high-protein diet on metabolic, gut and brain health.

Detailed description

The fibre mixture that will be investigated is hypothesized to improved metabolic, gut and brain health. It potentially increases insulin sensitivity, satiety, gut barrier function, improves food-reward related brain activity and decreases inflammation, gut permeability, and ectopic lipid accumulation, among other potential health effects. The fibre mixture will be administrated during 12 weeks combined a high-protein diet. The placebo-controlled parallel design of the study allows for a placebo group to use maltodextrin combined with a high-protein diet for 12 weeks. The high-protein diet is known to increase satiety and might enhance the difference between the intervention and placebo groups in terms of outcome measurements. The potential health effects as described earlier will be investigated using different techniques.

Conditions

• Insulin Resistance
• Impaired Glucose Tolerance
• PreDiabetes
• Overweight and Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fibre supplement (potato-pectin)	Fibre supplement
DIETARY_SUPPLEMENT	Placebo	Maltodextrin
DIETARY_SUPPLEMENT	High-protein diet	High-protein diet

Timeline

• Start date: 2022-09-08
• Primary completion: 2024-06-10
• Completion: 2024-06-10
• First posted: 2022-04-29
• Last updated: 2024-06-27

Locations

1 site across 1 country: Netherlands