Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

NCT ID: NCT02608372

Last Updated: 2018-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

High Blood Glucose

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

LD

Intervention Type OTHER

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

UP

Intervention Type OTHER

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

CTR

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

LD

Intervention Type OTHER

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

UP

Intervention Type OTHER

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

CTR

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

LD

Intervention Type OTHER

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

UP

Intervention Type OTHER

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

CTR

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

LD

Intervention Type OTHER

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

UP

Intervention Type OTHER

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

CTR

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

LD

Intervention Type OTHER

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

UP

Intervention Type OTHER

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

CTR

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

LD

Intervention Type OTHER

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

UP

Intervention Type OTHER

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

CTR

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LD

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

Intervention Type OTHER

UP

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

Intervention Type OTHER

CTR

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Education, Malaysia

OTHER_GOV

Sponsor Role collaborator

Universiti Malaysia Pahang

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Professor Lars Ove Dragsted

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lars O Dragsted, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32917417 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M221

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.