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Completed

NCT Number: NCT03512509

Comparison of Low GI and High GI Potatoes in Relation to Satiety (POSAT)

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low glycaemic potato

Other

The Carisma potato variety is used as the low glycaemic index potato.

High glycaemic potato

Other

The Arizona potato variety is used as the high glycaemic index potato.

Primary outcomes

  1. Subjective satiety evaluation

    Time frame: 3 hours

    Visual Analogue Scale (100mm) filled out by subjects to describe satiety.

Secondary outcomes

  1. Hunger, fullness, and prospective food consumption

    Time frame: 3 hours

    Visual Analogue Scale (100mm) filled out by subjects to describe hunger, fullness, and prospective food consumption.

  2. Energy consumed in Ad libitum meal

    Time frame: 30 minutes

    Energy intake (kJ) meassured by weighing of food consumed during a ad libitum meal.

Sponsors and collaborators

Lead sponsor

Anne Birgitte Raben

Other

Registry information

Official study title

Comparison of Low GI and High GI Potatoes in Relation to Satiety - a Randomised Control Trial

Acronym: POSAT

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 30, 2018
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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