Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

NCT02608372 | Completed DMC

• 1 other identifier: M221
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

High Blood Glucose

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  0- 180 min

Secondary Outcomes (10)

• Plasma glucose concentrations

  20, 40, 60, 90, 120 and 180 min

• Serum Insulin Area Under the Curve

  0-180 min

• Serum Insulin concentrations

  : 20, 40, 60, 90, 120 and 180 min

• ISI (0-180)

  0-180 min

• Serum C-peptide Area Under the Curve

  0-180 min

Other Outcomes (2)

• Metabolic profile in urine

  0-24 hrs

• Metabolic profile in plasma

  0-180 min

Study Arms (6)

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

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

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

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

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

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

Other: LD; Other: UP; Other: CTR

Interventions

LD OTHER

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

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

UP OTHER

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

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

CTR OTHER

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

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Ministry of Education, Malaysia: collaborator
• Universiti Malaysia Pahang: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32917417 DERIVED

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Lars O Dragsted, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2015
• First Posted: November 18, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

DK (1)