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

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

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.

Study Overview

• Status: Completed
• Conditions: Triacylglycerol Digestion
• Intervention / Treatment: Dietary supplement: Alginate Sausage; Other: Control Sausage

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle, Tyne And Wear, United Kingdom, NE2 4HH
      • Newcastle University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

Exclusion Criteria:

• pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alginate then Control; This group will be given the alginate then the control sausages	Dietary supplement: Alginate Sausage; Alginate sausage; Other: Control Sausage; Control Sausage
Experimental: Control then Alginate; This group will be given the control then alginate sausages	Dietary supplement: Alginate Sausage; Alginate sausage; Other: Control Sausage; Control Sausage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of circulating TAG in blood	mmol/L	4 hours after the test meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of circulating glucose in blood	mmol/L	4 hours after the test meal

Collaborators and Investigators

• Sponsor: Newcastle University
• Investigators: Principal Investigator: Jeffrey P Pearson, PhD, Newcastle University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): June 19, 2019
• Study Completion (Actual): June 19, 2019

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: alginate; fat digestion; sausages
• Other Study ID Numbers: SAU 01615

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No