High Blood GlucoseNCT02608372
Brown Seaweeds Effect on Glucose Tolerance and Appetite Response
A study testing LD, UP and CTR in people with High Blood Glucose, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Glucose
- What is being tested?
- LD, UP and CTR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, 1958
About this study
Official title: Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study
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.
Read the 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.
- Conditions
- High Blood Glucose
- Being tested
- LD, UP, CTR
- Keywords
- Seaweed, Insulin, Glucose tolerance, C-peptide, Appetide, Metabolomics
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDOther
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
UPOther
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
CTROther
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-UP-CTR Receives: Other: LD; Other: UP; Other: CTR |
| Sequence B | Experimental | The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-CTR-UP Receives: Other: LD; Other: UP; Other: CTR |
| Sequence C | Experimental | The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-LD-CTR Receives: Other: LD; Other: UP; Other: CTR |
| Sequence D | Experimental | The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-CTR-LD Receives: Other: LD; Other: UP; Other: CTR |
| Sequence E | Experimental | The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-LD-UP Receives: Other: LD; Other: UP; Other: CTR |
| Sequence F | Experimental | The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-UP-LD Receives: Other: LD; Other: UP; Other: CTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0- 180 min
Secondary outcomes (10)
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.
Measured: 20, 40, 60, 90, 120 and 180 min
Serum Insulin Area Under the Curve
Area Under the Curve (AUC) for serum insulin.
Measured: 0-180 min
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.
Measured: : 20, 40, 60, 90, 120 and 180 min
ISI (0-180)
Matsuda's Insulin Sensitivity Index
Measured: 0-180 min
Serum C-peptide Area Under the Curve
Area Under the Curve (AUC) for serum C-peptide.
Measured: 0-180 min
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.
Measured: 20, 40, 60, 90, 120 and 180 min
Plasma GLP-1 Area Under the Curve
Area Under the Curve (AUC) for plasma GLP-1.
Measured: 0-180 min
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
Measured: 20, 40, 60, 90, 120 and 180 min
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)
Measured: 0-180 min
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
Measured: 20, 40, 50, 70, 100, 130 and 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Malaysia, Universiti Malaysia Pahang
- Responsible party
- Principal investigator, Professor Lars Ove Dragsted, University of Copenhagen
- Investigators
- Lars O Dragsted, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608372
- Sponsor's protocol ID
- M221
- Status last verified
- Aug 2018
- First submitted
- 14 Nov 2015
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32917417
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study
- ClinicalTrials.gov ID
- NCT02608372
- Acronym / sponsor ID
- M221
- Conditions
- High Blood Glucose
- Keywords
- Seaweed, Insulin, Glucose tolerance, C-peptide, Appetide, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Ministry of Education, Malaysia, Universiti Malaysia Pahang
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Other: LD, Other: UP, Other: CTRThe meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-UP-CTR |
| Sequence B | Experimental | Other: LD, Other: UP, Other: CTRThe meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-CTR-UP |
| Sequence C | Experimental | Other: LD, Other: UP, Other: CTRThe meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-LD-CTR |
| Sequence D | Experimental | Other: LD, Other: UP, Other: CTRThe meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-CTR-LD |
| Sequence E | Experimental | Other: LD, Other: UP, Other: CTRThe meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-LD-UP |
| Sequence F | Experimental | Other: LD, Other: UP, Other: CTRThe meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-UP-LD |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDParticipants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water. | Other | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
| UPParticipants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water. | Other | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
| CTRParticipants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water. | Other | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
Primary outcome
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.
10 secondary outcomes
Plasma glucose concentrations
Time frame: 20, 40, 60, 90, 120 and 180 min
Serum Insulin Area Under the Curve
Time frame: 0-180 min
Serum Insulin concentrations
Time frame: : 20, 40, 60, 90, 120 and 180 min
ISI (0-180)
Time frame: 0-180 min
Serum C-peptide Area Under the Curve
Time frame: 0-180 min
Serum C-peptide concentrations
Time frame: 20, 40, 60, 90, 120 and 180 min
Plasma GLP-1 Area Under the Curve
Time frame: 0-180 min
Plasma GLP-1 concentrations
Time frame: 20, 40, 60, 90, 120 and 180 min
Subjective appetite scores assessed by visual analogue scale (VAS)
Time frame: 0-180 min
Subjective appetite scores assessed by visual analogue scale (VAS)
Time frame: 20, 40, 50, 70, 100, 130 and 180 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Derived from this study: PubMed 32917417Zaharudin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars O Dragsted, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LD, UP and CTR in people with High Blood Glucose, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose Area Under the Curve (Glucose AUC) (time frame: 0- 180 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02608372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.