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Completed

NCT Number: NCT02608372

Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

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.

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Key information

Conditions

High Blood Glucose Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LD

Other

Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.

UP

Other

Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.

CTR

Other

Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Ministry of Education, Malaysia
  • Universiti Malaysia Pahang

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2015
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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