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

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ClinicalTrials.gov Identifier: NCT03512509
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Anne Birgitte Raben, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Obesity Other: Low glycaemic potato Other: High glycaemic potato Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-blind randomized crossover
Masking: Single (Participant)
Masking Description: Subjets will not be aware of which test meal they will recieve first, and are not able to distinguish between the two potatoes.
Primary Purpose: Prevention
Official Title: Comparison of Low GI and High GI Potatoes in Relation to Satiety - a Randomised Control Trial
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : August 20, 2018

Arm Intervention/treatment
Experimental: A
Low glycaemic potato
Other: Low glycaemic potato
The Carisma potato variety is used as the low glycaemic index potato.

Experimental: B
High glycaemic potato
Other: High glycaemic potato
The Arizona potato variety is used as the high glycaemic index potato.




Primary Outcome Measures :
  1. Subjective satiety evaluation [ Time Frame: 3 hours ]
    Visual Analogue Scale (100mm) filled out by subjects to describe satiety.


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512509


Locations
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Denmark
University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
Anne Birgitte Raben
Investigators
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Principal Investigator: Anne Raben, Professor Department of Nutrition, Sports and Exercise, University of Copenhagen

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Responsible Party: Anne Birgitte Raben, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03512509     History of Changes
Other Study ID Numbers: B344
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No