Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

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: NCT02608372
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
Ministry of Education, Malaysia
Universiti Malaysia Pahang
Information provided by (Responsible Party):
Professor Lars Ove Dragsted, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE November 14, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date August 27, 2018
Study Start Date  ICMJE May 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02608372 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • 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.
  • Serum Insulin Area Under the Curve [ Time Frame: 0-180 min ]
    Area Under the Curve (AUC) for serum insulin.
  • 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.
  • ISI (0-180) [ Time Frame: 0-180 min ]
    Matsuda's Insulin Sensitivity Index
  • Serum C-peptide Area Under the Curve [ Time Frame: 0-180 min ]
    Area Under the Curve (AUC) for serum C-peptide.
  • 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.
  • Plasma GLP-1 Area Under the Curve [ Time Frame: 0-180 min ]
    Area Under the Curve (AUC) for plasma GLP-1.
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • 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.
  • Serum Insulin Area Under the Curve [ Time Frame: 0-180 min ]
    Area Under the Curve (AUC) for serum insulin.
  • 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.
  • ISI (0-180) [ Time Frame: 0-180 min ]
    Matsuda's Insulin Sensitivity Index
  • Serum C-peptide Area Under the Curve [ Time Frame: 0-180 min ]
    Area Under the Curve (AUC) for serum C-peptide.
  • 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.
  • Plasma GLP-1 Area Under the Curve [ Time Frame: 0-180 min ]
    Area Under the Curve (AUC) for plasma GLP-1.
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2017)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: November 16, 2015)
  • 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).
  • 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).
 
Descriptive Information
Brief Title  ICMJE Brown Seaweeds Effect on Glucose Tolerance and Appetite Response
Official Title  ICMJE Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE High Blood Glucose
Intervention  ICMJE
  • Other: LD
    Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
  • Other: UP
    Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
  • Other: CTR
    Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: LD
    • Other: UP
    • Other: CTR
  • 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
    Interventions:
    • Other: LD
    • Other: UP
    • Other: CTR
  • 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
    Interventions:
    • Other: LD
    • Other: UP
    • Other: CTR
  • 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
    Interventions:
    • Other: LD
    • Other: UP
    • Other: CTR
  • 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
    Interventions:
    • Other: LD
    • Other: UP
    • Other: CTR
  • 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
    Interventions:
    • Other: LD
    • Other: UP
    • Other: CTR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2015)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02608372
Other Study ID Numbers  ICMJE M221
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Lars Ove Dragsted, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE
  • Ministry of Education, Malaysia
  • Universiti Malaysia Pahang
Investigators  ICMJE
Principal Investigator: Lars O Dragsted, PhD University of Copenhagen
PRS Account University of Copenhagen
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP