Clinical trial NCT02608372: Brown Seaweeds Effect on Glucose Tolerance and Appetite Response
Official title: Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Glucose
Keywords: Seaweed
Insulin
Glucose tolerance
C-peptide
Appetide
Metabolomics
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Malaysia
name: Universiti Malaysia Pahang
First posted: 2015-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma glucose Area Under the Curve (Glucose AUC)
timeFrame: 0- 180 min
Secondary outcomes:
measure: Plasma glucose concentrations
timeFrame: 20, 40, 60, 90, 120 and 180 min
measure: Serum Insulin Area Under the Curve
timeFrame: 0-180 min
measure: Serum Insulin concentrations
timeFrame: : 20, 40, 60, 90, 120 and 180 min
measure: ISI (0-180)
timeFrame: 0-180 min
measure: Serum C-peptide Area Under the Curve
timeFrame: 0-180 min
measure: Serum C-peptide concentrations
timeFrame: 20, 40, 60, 90, 120 and 180 min
measure: Plasma GLP-1 Area Under the Curve
timeFrame: 0-180 min
measure: Plasma GLP-1 concentrations
timeFrame: 20, 40, 60, 90, 120 and 180 min
measure: Subjective appetite scores assessed by visual analogue scale (VAS)
timeFrame: 0-180 min
measure: Subjective appetite scores assessed by visual analogue scale (VAS)
timeFrame: 20, 40, 50, 70, 100, 130 and 180 min
Other outcomes:
measure: Metabolic profile in urine
timeFrame: 0-24 hrs
measure: Metabolic profile in plasma
timeFrame: 0-180 min
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Lars O Dragsted, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.