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Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02608372
Enrollment
20
Registered
2015-11-18
Start date
2015-05-31
Completion date
2015-08-31
Last updated
2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Blood Glucose

Keywords

Seaweed, Insulin, Glucose tolerance, C-peptide, Appetide, Metabolomics

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.

Interventions

OTHERLD

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

OTHERUP

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

OTHERCTR

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

Sponsors

Ministry of Education, Malaysia
CollaboratorOTHER_GOV
Universiti Malaysia Pahang
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Plasma glucose concentrations20, 40, 60, 90, 120 and 180 minChanges 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 Curve0-180 minArea Under the Curve (AUC) for serum insulin.
Serum Insulin concentrations: 20, 40, 60, 90, 120 and 180 minChanges 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)0-180 minMatsuda's Insulin Sensitivity Index
Serum C-peptide Area Under the Curve0-180 minArea Under the Curve (AUC) for serum C-peptide.
Plasma GLP-1 concentrations20, 40, 60, 90, 120 and 180 minChanges 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)0-180 minArea Under the Curve (AUC) for all VAS outcomes (satiety, hunger, fullness, prospective food consumption and comfort)
Serum C-peptide concentrations20, 40, 60, 90, 120 and 180 minChanges 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 Curve0-180 minArea Under the Curve (AUC) for plasma GLP-1.

Other

MeasureTime frameDescription
Metabolic profile in urine0-24 hrsUntargeted 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 plasma0-180 minUntargeted 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026