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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02608372 |
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Date of registration:
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14/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Brown Seaweeds Effect on Glucose Tolerance and Appetite Response
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Scientific title:
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Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02608372 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Lars O Dragsted, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Copenhagen |
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Key inclusion & exclusion 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.
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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High Blood Glucose
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Intervention(s)
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Other: UP
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Other: CTR
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Other: LD
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Primary Outcome(s)
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Plasma glucose Area Under the Curve (Glucose AUC)
[Time Frame: 0- 180 min]
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Secondary Outcome(s)
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Plasma GLP-1 concentrations
[Time Frame: 20, 40, 60, 90, 120 and 180 min]
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Serum Insulin concentrations
[Time Frame: : 20, 40, 60, 90, 120 and 180 min]
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Subjective appetite scores assessed by visual analogue scale (VAS)
[Time Frame: 20, 40, 50, 70, 100, 130 and 180 min]
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Serum Insulin Area Under the Curve
[Time Frame: 0-180 min]
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Subjective appetite scores assessed by visual analogue scale (VAS)
[Time Frame: 0-180 min]
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ISI (0-180)
[Time Frame: 0-180 min]
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Plasma glucose concentrations
[Time Frame: 20, 40, 60, 90, 120 and 180 min]
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Serum C-peptide Area Under the Curve
[Time Frame: 0-180 min]
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Plasma GLP-1 Area Under the Curve
[Time Frame: 0-180 min]
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Serum C-peptide concentrations
[Time Frame: 20, 40, 60, 90, 120 and 180 min]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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