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Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

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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

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.

Condition or disease Intervention/treatment Phase
High Blood Glucose Other: LD Other: UP Other: CTR Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study
Study Start Date : May 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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
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.

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
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.

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
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.

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
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.

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
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.

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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Serum Insulin Area Under the Curve [ Time Frame: 0-180 min ]
    Area Under the Curve (AUC) for serum insulin.

  3. 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.

  4. ISI (0-180) [ Time Frame: 0-180 min ]
    Matsuda's Insulin Sensitivity Index

  5. Serum C-peptide Area Under the Curve [ Time Frame: 0-180 min ]
    Area Under the Curve (AUC) for serum C-peptide.

  6. 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.

  7. Plasma GLP-1 Area Under the Curve [ Time Frame: 0-180 min ]
    Area Under the Curve (AUC) for plasma GLP-1.

  8. 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

  9. 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)

  10. 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


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


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): NCT02608372


Locations
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Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Ministry of Education, Malaysia
Universiti Malaysia Pahang
Investigators
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Principal Investigator: Lars O Dragsted, PhD University of Copenhagen

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Responsible Party: Professor Lars Ove Dragsted, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02608372     History of Changes
Other Study ID Numbers: M221
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Keywords provided by Professor Lars Ove Dragsted, University of Copenhagen:
Seaweed
Insulin
Glucose tolerance
C-peptide
Appetide
Metabolomics
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases