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Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

Primary Purpose

High Blood Glucose

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
LD
UP
CTR
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Blood Glucose focused on measuring Seaweed, Insulin, Glucose tolerance, C-peptide, Appetide, Metabolomics

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Nutrition, Exercise and Sports, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence A

Sequence B

Sequence C

Sequence D

Sequence E

Sequence F

Arm Description

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-UP-CTR

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-CTR-UP

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-LD-CTR

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-CTR-LD

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-LD-UP

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-UP-LD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2015
Last Updated
August 23, 2018
Sponsor
University of Copenhagen
Collaborators
Ministry of Education, Malaysia, Universiti Malaysia Pahang
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1. Study Identification

Unique Protocol Identification Number
NCT02608372
Brief Title
Brown Seaweeds Effect on Glucose Tolerance and Appetite Response
Official Title
Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Ministry of Education, Malaysia, Universiti Malaysia Pahang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Glucose
Keywords
Seaweed, Insulin, Glucose tolerance, C-peptide, Appetide, Metabolomics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A
Arm Type
Experimental
Arm Description
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-UP-CTR
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-CTR-UP
Arm Title
Sequence C
Arm Type
Experimental
Arm Description
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-LD-CTR
Arm Title
Sequence D
Arm Type
Experimental
Arm Description
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-CTR-LD
Arm Title
Sequence E
Arm Type
Experimental
Arm Description
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-LD-UP
Arm Title
Sequence F
Arm Type
Experimental
Arm Description
The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-UP-LD
Intervention Type
Other
Intervention Name(s)
LD
Intervention Description
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Intervention Type
Other
Intervention Name(s)
UP
Intervention Description
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Intervention Type
Other
Intervention Name(s)
CTR
Intervention Description
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
Primary Outcome Measure Information:
Title
Plasma glucose Area Under the Curve (Glucose AUC)
Description
The area under the plasma glucose concentration curve was calculated from 0-180 min after 30 g of corn starch was ingested.
Time Frame
0- 180 min
Secondary Outcome Measure Information:
Title
Plasma glucose concentrations
Description
Changes in the glucose concentrations determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate.
Time Frame
20, 40, 60, 90, 120 and 180 min
Title
Serum Insulin Area Under the Curve
Description
Area Under the Curve (AUC) for serum insulin.
Time Frame
0-180 min
Title
Serum Insulin concentrations
Description
Changes in the insulin concentrations determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate.
Time Frame
: 20, 40, 60, 90, 120 and 180 min
Title
ISI (0-180)
Description
Matsuda's Insulin Sensitivity Index
Time Frame
0-180 min
Title
Serum C-peptide Area Under the Curve
Description
Area Under the Curve (AUC) for serum C-peptide.
Time Frame
0-180 min
Title
Serum C-peptide concentrations
Description
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.
Time Frame
20, 40, 60, 90, 120 and 180 min
Title
Plasma GLP-1 Area Under the Curve
Description
Area Under the Curve (AUC) for plasma GLP-1.
Time Frame
0-180 min
Title
Plasma GLP-1 concentrations
Description
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
Time Frame
20, 40, 60, 90, 120 and 180 min
Title
Subjective appetite scores assessed by visual analogue scale (VAS)
Description
Area Under the Curve (AUC) for all VAS outcomes (satiety, hunger, fullness, prospective food consumption and comfort)
Time Frame
0-180 min
Title
Subjective appetite scores assessed by visual analogue scale (VAS)
Description
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
Time Frame
20, 40, 50, 70, 100, 130 and 180 min
Other Pre-specified Outcome Measures:
Title
Metabolic profile in urine
Description
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.
Time Frame
0-24 hrs
Title
Metabolic profile in plasma
Description
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.
Time Frame
0-180 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars O Dragsted, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports, University of Copenhagen
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32917417
Citation
Zaharudin N, Tullin M, Pekmez CT, Sloth JJ, Rasmussen RR, Dragsted LO. Effects of brown seaweeds on postprandial glucose, insulin and appetite in humans - A randomized, 3-way, blinded, cross-over meal study. Clin Nutr. 2021 Mar;40(3):830-838. doi: 10.1016/j.clnu.2020.08.027. Epub 2020 Aug 31.
Results Reference
derived

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Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

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