Brown Seaweeds Effect on Glucose Tolerance and Appetite Response

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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High Blood Glucose

Intervention / Treatment
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* Other: LD
* Other: UP
* Other: CTR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>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<br>* Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: UP<br>* Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: CTR<br>* Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.<br>|
| Experimental: Sequence B<br>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<br>* Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: UP<br>* Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: CTR<br>* Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.<br>|
| Experimental: Sequence C<br>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<br>* Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: UP<br>* Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: CTR<br>* Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.<br>|
| Experimental: Sequence D<br>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<br>* Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: UP<br>* Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: CTR<br>* Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.<br>|
| Experimental: Sequence E<br>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<br>* Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: UP<br>* Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: CTR<br>* Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.<br>|
| Experimental: Sequence F<br>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<br>* Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: UP<br>* Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.<br>Other: CTR<br>* Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 20, 40, 60, 90, 120 and 180 min | 
| Serum Insulin Area Under the Curve | Area Under the Curve (AUC) for serum insulin. | 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. | : 20, 40, 60, 90, 120 and 180 min | 
| ISI (0-180) | Matsuda's Insulin Sensitivity Index | 0-180 min | 
| Serum C-peptide Area Under the Curve | Area Under the Curve (AUC) for serum C-peptide. | 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. | 20, 40, 60, 90, 120 and 180 min | 
| Plasma GLP-1 Area Under the Curve | Area Under the Curve (AUC) for plasma GLP-1. | 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 | 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) | 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 | 20, 40, 50, 70, 100, 130 and 180 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seaweed, Insulin, Glucose tolerance, C-peptide, Appetide, Metabolomics