Clinical trial NCT03512509: Comparison of Low GI and High GI Potatoes in Relation to Satiety (POSAT)
Official title: Comparison of Low GI and High GI Potatoes in Relation to Satiety - a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-blind randomized crossover
Primary purpose: PREVENTION

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.

Detailed description: The POSAT study follows a single-blinded randomized crossover design. Each subject will have two separate intervention days with at least a six-day washout period in between. On the two intervention days the subjects will be randomized into receiving a breakfast containing isocaloric amounts of either low or high GI potatoes. VAS will be measured 5 minutes before the meal, immediately after the meal is consumed and in intervals of 30 minutes thereafter until 2,5 hours after the initial meal. After this the subjects will be served a standardized homogenous ad libitum meal. The amount of food consumed will be registered. The subjects will be asked to fast for 8-10 hours prior to the trial days and abstain from vigorous physical activity and alcohol consumption for 2 days prior to each trial day. The trial will be conducted over a total of 8 days with 5-6 study subjects pr. trial day. The trial days will be spread out over a total of 2 weeks to allow for a 1-week washout period between trial days for each subject.

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective satiety evaluation
timeFrame: 3 hours
Secondary outcomes:
measure: Hunger, fullness, and prospective food consumption
timeFrame: 3 hours
measure: Energy consumed in Ad libitum meal
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: Department of Nutrition, Sports and Exercise, University of Copenhagen
name: Anne Raben, Professor
role: PRINCIPAL_INVESTIGATOR
References: