Obesity Clinical Trial
— POSATOfficial title:
Comparison of Low GI and High GI Potatoes in Relation to Satiety - a Randomised Control Trial
NCT number | NCT03512509 |
Other study ID # | B344 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 5, 2018 |
Est. completion date | August 20, 2018 |
Verified date | October 2018 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a single-blind, randomised crossover study, investigating how a high glycaemic potato affects satiety in humans compared to a low glycaemic potato. This is done to shed further light on the discussion about whether potatoes with a high glycaemic index increases the risk of overweight and obesity and thus indirectly type 2 diabetes and cardiovascular disease.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 20, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Healthy men - Body mass index (BMI) 18-27 kg/m2 - Age 18-40 years - Signed informed consent - Able to eat 500 grams of potato for breakfast Exclusion Criteria: - Chronic diseases as diabetes, cardiovascular diseases or other chronic metabolic diseases, which could affect the results. - Use of daily prescription medicine (mild analgesics and antihistamines are allowed). - Use of medicine or dietary supplements that can affect ones appetite one month before the start of the study. - Smoking or have been smoking or using any nicotine products (gum or e-cigarette) within the last 3 months. Irregular smoking is allowed. - Elite athletes defined as doing >10 hours of strenuous physical activity per week. - Participation in other clinical studies <1 month before or during the study. - Inability, physically or psychologically, to comply with the procedures required by the study protocol. Judged by the investigators. - Any food allergies. - Weight change of ±3 kg from screening to the trial has been conducted. - Inability to complete the trial within 3 months after screening. - Unable to fast 8-10 hours before the trial days. |
Country | Name | City | State |
---|---|---|---|
Denmark | University of Copenhagen | Frederiksberg |
Lead Sponsor | Collaborator |
---|---|
Anne Birgitte Raben |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective satiety evaluation | Visual Analogue Scale (100mm) filled out by subjects to describe satiety. | 3 hours | |
Secondary | Hunger, fullness, and prospective food consumption | Visual Analogue Scale (100mm) filled out by subjects to describe hunger, fullness, and prospective food consumption. | 3 hours | |
Secondary | Energy consumed in Ad libitum meal | Energy intake (kJ) meassured by weighing of food consumed during a ad libitum meal. | 30 minutes |
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