Comparison of Low GI and High GI Potatoes in Relation to Satiety (POSAT)
POSAT
1 other identifier
interventional
22
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Feb 2018
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2018
CompletedFirst Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2018
CompletedOctober 11, 2018
October 1, 2018
3 months
March 15, 2018
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective satiety evaluation
Visual Analogue Scale (100mm) filled out by subjects to describe satiety.
3 hours
Secondary Outcomes (2)
Hunger, fullness, and prospective food consumption
3 hours
Energy consumed in Ad libitum meal
30 minutes
Study Arms (2)
A
EXPERIMENTALLow glycaemic potato
B
EXPERIMENTALHigh glycaemic potato
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Copenhagen
Frederiksberg, 1958, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Raben, Professor
Department of Nutrition, Sports and Exercise, University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Subjets will not be aware of which test meal they will recieve first, and are not able to distinguish between the two potatoes.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 15, 2018
First Posted
April 30, 2018
Study Start
February 5, 2018
Primary Completion
April 30, 2018
Study Completion
August 20, 2018
Last Updated
October 11, 2018
Record last verified: 2018-10