- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02608372
Brown Seaweeds Effect on Glucose Tolerance and Appetite Response
Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Frederiksberg, Denmark, 1958
- Department of Nutrition, Exercise and Sports, University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
|
Experimental: 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
|
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
|
Experimental: 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
|
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
|
Experimental: 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
|
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
|
Experimental: 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
|
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
|
Experimental: 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
|
Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0- 180 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma glucose concentrations
Time Frame: 20, 40, 60, 90, 120 and 180 min
|
Changes in the glucose concentrations determined by a mixed model analysis and subsequently at each time point with time 0 as a co-variate.
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20, 40, 60, 90, 120 and 180 min
|
Serum Insulin Area Under the Curve
Time Frame: 0-180 min
|
Area Under the Curve (AUC) for serum insulin.
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0-180 min
|
Serum Insulin concentrations
Time Frame: : 20, 40, 60, 90, 120 and 180 min
|
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)
Time Frame: 0-180 min
|
Matsuda's Insulin Sensitivity Index
|
0-180 min
|
Serum C-peptide Area Under the Curve
Time Frame: 0-180 min
|
Area Under the Curve (AUC) for serum C-peptide.
|
0-180 min
|
Serum C-peptide concentrations
Time Frame: 20, 40, 60, 90, 120 and 180 min
|
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
Time Frame: 0-180 min
|
Area Under the Curve (AUC) for plasma GLP-1.
|
0-180 min
|
Plasma GLP-1 concentrations
Time Frame: 20, 40, 60, 90, 120 and 180 min
|
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)
Time Frame: 0-180 min
|
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)
Time Frame: 20, 40, 50, 70, 100, 130 and 180 min
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic profile in urine
Time Frame: 0-24 hrs
|
Untargeted metabolic profile of urine samples measured in all samples collected before the meal and postprandially from 0-90 min, 90-180 min as well as in samples collected up to 24 hours later.
The totality of the profiles is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA) after dividing the data into a training and test set.
Contrasts between each of the treatment groups and the placebo group will be assessed using the receiver-operator characteristics (ROC curves) comparing the training and test set.
|
0-24 hrs
|
Metabolic profile in plasma
Time Frame: 0-180 min
|
Untargeted metabolic profile of plasma measured in all samples collected before the meal and postprandially from 0-180 min.
The totality of the profile is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA) after dividing the data into a training and test set.
Contrasts between each of the treatment groups and the placebo group will be assessed using the receiver-operator characteristics (ROC curves) comparing the training and test set.
|
0-180 min
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M221
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