Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860337
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Newcastle University

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.

Condition or disease Intervention/treatment Phase
Triacylglycerol Digestion Dietary Supplement: Alginate Sausage Other: Control Sausage Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double blind randomised controlled trial
Masking: Double (Participant, Investigator)
Masking Description: neither the researcher or the participant will know if the participant is eating alginate or control sausages
Primary Purpose: Basic Science
Official Title: The Effect of Alginate on Carbohydrate and Fat Digestion in a Mixed Meal - A Pilot Trial
Actual Study Start Date : May 13, 2019
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : June 19, 2019

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




Primary Outcome Measures :
  1. Concentration of circulating TAG in blood [ Time Frame: 4 hours after the test meal ]
    mmol/L


Secondary Outcome Measures :
  1. Concentration of circulating glucose in blood [ Time Frame: 4 hours after the test meal ]
    mmol/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860337


Locations
Layout table for location information
United Kingdom
Newcastle University
Newcastle, Tyne And Wear, United Kingdom, NE2 4HH
Sponsors and Collaborators
Newcastle University
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey P Pearson, PhD Newcastle University

Layout table for additonal information
Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT03860337     History of Changes
Other Study ID Numbers: SAU 01615
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Newcastle University:
fat digestion
alginate
sausages