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

NCT ID: NCT03860337

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2019-06-19

Brief 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.

Detailed 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.

Conditions

Triacylglycerol Digestion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Alginate then Control

This group will be given the alginate then the control sausages

Group Type: EXPERIMENTAL

Alginate Sausage

Intervention Type: DIETARY_SUPPLEMENT

Alginate sausage

Control Sausage

Intervention Type: OTHER

Control Sausage

Control then Alginate

This group will be given the control then alginate sausages

Group Type: EXPERIMENTAL

Alginate Sausage

Intervention Type: DIETARY_SUPPLEMENT

Alginate sausage

Control Sausage

Intervention Type: OTHER

Control Sausage

Interventions

Alginate Sausage

Alginate sausage

Intervention Type: DIETARY_SUPPLEMENT

Control Sausage

Control Sausage

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

• pregnant or lactating.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Newcastle University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey P Pearson, PhD

Role: PRINCIPAL_INVESTIGATOR

Newcastle University

Locations

Newcastle University

Newcastle, Tyne and Wear, United Kingdom

Countries

United Kingdom

Other Identifiers

SAU 01615

Identifier Type: -

Identifier Source: org_study_id