Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

August 23, 2018 updated by: Professor Lars Ove Dragsted, University of Copenhagen

Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study

The project is a randomized, 3-way, blinded crossover trial in which 20 healthy, fasted participants consume meals with 30 g of a linear corn starch and 5 g of one of the seaweeds, Laminara digitata or Undaria pinnatifida or a pea protein control. The primary aim is to investigate whether the brown seaweeds affect the postprandial glucose Area Under the Curve (AUC). Stomach emptying, insulin, C-peptide, appetite-regulating hormones (oxyntomodulin, glucagon, GLP-1 and PYY), and specific metabolites from the seaweeds in the urine and plasma as well as subjective satiety are also analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Brown seaweeds may contain bioactive compounds as they contain secondary plant metabolites, including flavonoids and other phenolic compounds as well as carotenoids. Dietary fibre is the major component of brown seaweeds, mainly composed from laminarans, alginates, fucans and cellulose. Several dietary fibers and secondary plant metabolites have been shown to have an impact on health and more specifically on glycemic control. Therefore, the aim of this study was to investigate whether two selected brown seaweeds have an effect on the postprandial glucose response to a starch load as well as several secondary measures, including appetite responses.

In a controlled crossover trial, 20 healthy fasted participants consumed 5 g of either Laminaria digitata (LD) or Undaria pinnatifida (UP) or 1 g of pea protein (CTR). The volunteers concomitantly ingested 200 mL of a drink with corn starch. Blood samples were drawn at baseline, as well as 20, 40, 60, 90, 120 and 180 min after the meal. Differences in glucose, insulin, C-peptide, plasma incretin concentrations, and insulin sensitivity index (ISI) were analyzed and appetite was scored by a visual analogue scale and a subsequent ad libitum test meal.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Frederiksberg, Denmark, 1958
        • Department of Nutrition, Exercise and Sports, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

BMI 20-25 kg/m2. Waist circumference < 102 cm. Non-smoking. Like (can tolerate) seaweed, pasta, meat sauce as these foods are part of the test meal.

Can tolerate paracetamol (Pinex, Actavis, Denmark).

Exclusion Criteria:

Systemic infections, psychiatric or metabolic diseases, and any clinical condition, chronic or frequent use of medication (including blood thinners, excluding contraceptives), smoking (throughout the trial and 12 months before the start of the experiment), blood donations during or in the month leading up to the study period, elite athletes (> 10 hours of hard exercise / week, self-reported), high intake of alcohol (defined as a weekly intake of > 7 units for women and > 14 units for men), have or have had a drug addiction, participation in other scientific studies during the study period, lactating, pregnancy or ongoing planning of pregnancy, and vegetarianism or veganism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-UP-CTR
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
Experimental: Sequence B
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-CTR-UP
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
Experimental: Sequence C
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-LD-CTR
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
Experimental: Sequence D
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-CTR-LD
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
Experimental: Sequence E
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-LD-UP
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
Experimental: Sequence F
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-UP-LD
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma glucose Area Under the Curve (Glucose AUC)
Time Frame: 0- 180 min
The area under the plasma glucose concentration curve was calculated from 0-180 min after 30 g of corn starch was ingested.
0- 180 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma glucose concentrations
Time Frame: 20, 40, 60, 90, 120 and 180 min
Changes in the glucose concentrations determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate.
20, 40, 60, 90, 120 and 180 min
Serum Insulin Area Under the Curve
Time Frame: 0-180 min
Area Under the Curve (AUC) for serum insulin.
0-180 min
Serum Insulin concentrations
Time Frame: : 20, 40, 60, 90, 120 and 180 min
Changes in the insulin concentrations determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate.
: 20, 40, 60, 90, 120 and 180 min
ISI (0-180)
Time Frame: 0-180 min
Matsuda's Insulin Sensitivity Index
0-180 min
Serum C-peptide Area Under the Curve
Time Frame: 0-180 min
Area Under the Curve (AUC) for serum C-peptide.
0-180 min
Serum C-peptide concentrations
Time Frame: 20, 40, 60, 90, 120 and 180 min
Changes in the C-peptide concentrations determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate.
20, 40, 60, 90, 120 and 180 min
Plasma GLP-1 Area Under the Curve
Time Frame: 0-180 min
Area Under the Curve (AUC) for plasma GLP-1.
0-180 min
Plasma GLP-1 concentrations
Time Frame: 20, 40, 60, 90, 120 and 180 min
Changes in the plasma GLP-1 concentrations determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate
20, 40, 60, 90, 120 and 180 min
Subjective appetite scores assessed by visual analogue scale (VAS)
Time Frame: 0-180 min
Area Under the Curve (AUC) for all VAS outcomes (satiety, hunger, fullness, prospective food consumption and comfort)
0-180 min
Subjective appetite scores assessed by visual analogue scale (VAS)
Time Frame: 20, 40, 50, 70, 100, 130 and 180 min
Changes in VAS outcomes (satiety, hunger, fullness, prospective food consumption and comfort), determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate
20, 40, 50, 70, 100, 130 and 180 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic profile in urine
Time Frame: 0-24 hrs
Untargeted metabolic profile of urine samples measured in all samples collected before the meal and postprandially from 0-90 min, 90-180 min as well as in samples collected up to 24 hours later. The totality of the profiles is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA) after dividing the data into a training and test set. Contrasts between each of the treatment groups and the placebo group will be assessed using the receiver-operator characteristics (ROC curves) comparing the training and test set.
0-24 hrs
Metabolic profile in plasma
Time Frame: 0-180 min
Untargeted metabolic profile of plasma measured in all samples collected before the meal and postprandially from 0-180 min. The totality of the profile is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA) after dividing the data into a training and test set. Contrasts between each of the treatment groups and the placebo group will be assessed using the receiver-operator characteristics (ROC curves) comparing the training and test set.
0-180 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 14, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

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