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Completed

NCT Number: NCT03860337

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

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.

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Key information

Conditions

Triacylglycerol Digestion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Newcastle University

Newcastle, Tyne and Wear, NE2 4HH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

  • pregnant or lactating.

Treatment and study plan

Alginate Sausage

Dietary Supplement

Alginate sausage

Control Sausage

Other

Control Sausage

Primary outcomes

  1. Concentration of circulating TAG in blood

    Time frame: 4 hours after the test meal

    mmol/L

Secondary outcomes

  1. Concentration of circulating glucose in blood

    Time frame: 4 hours after the test meal

    mmol/L

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2019
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.