The Effect of Alginate on Carbohydrate and Fat Digestion in a Mixed Meal

Triacylglycerol Digestion Clinical Trial

Official title:

The Effect of Alginate on Carbohydrate and Fat Digestion in a Mixed Meal - A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860337
• Other study ID #: SAU 01615
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: June 19, 2019

Study information

• Verified date: September 2019
• Source: Newcastle University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effect of an extract of brown seaweed, called alginate, on fat digestion. The extract has been cooked into sausages and the alginate sausages will be compared to the same sausages that do not contain alginate. People taking part in the study will come to the study centre twice. Once to have the alginate sausage meal or the normal sausage meal and on the second visit they will have the other meal so then end up having had both types of sausages. The level of fat in their blood will be monitored over the four hours after the meal. The rate and amount of fat that moves into the blood after a meal is an indication of the amount of fat digestion. We believe that less fat will be digested and move into the blood when the volunteers eat the alginate sausages compared to the normal sausages.

Description:

Alginate is an extract of brown seaweed and has been shown to reduce lipase activity in vitro. Lipase is a valid target for anti-obesity products as shown by the pharmaceutical drug orlistat which targets the same enzyme. Reducing the amount of lipase activity will reduce the amount of triacylglycerol (TAG) that will be digested and therefore absorbed and will be seen as a reduction in the level of circulating TAG in the blood. Adding alginate to a range of food products that are simple to include into the diet could help with the management of obesity. In this study, sausages containing alginate have been manufactured for us along with matched control sausage. The circulating TAG in the blood will be measured via fingerpick blood samples every 30 minutes for four hours after the volunteers have eaten either alginate sausages or normal sausages. The volunteers will come for two visits and consume the other sausage meal at the second so they will have had both types of sausage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• pregnant or lactating.

Related Conditions & MeSH terms

• Triacylglycerol Digestion

Intervention

Dietary Supplement:
• Alginate Sausage
Alginate sausage

Other:
• Control Sausage
Control Sausage

Locations

Country	Name	City	State
United Kingdom	Newcastle University	Newcastle	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of circulating TAG in blood	mmol/L	4 hours after the test meal
Secondary	Concentration of circulating glucose in blood	mmol/L	4 hours after the test meal