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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Low glycaemic potato; Other: High glycaemic potato

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 1958
    • University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective satiety evaluation	Visual Analogue Scale (100mm) filled out by subjects to describe satiety.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hunger, fullness, and prospective food consumption	Visual Analogue Scale (100mm) filled out by subjects to describe hunger, fullness, and prospective food consumption.	3 hours
Energy consumed in Ad libitum meal	Energy intake (kJ) meassured by weighing of food consumed during a ad libitum meal.	30 minutes

Collaborators and Investigators

• Sponsor: Anne Birgitte Raben
• Investigators: Principal Investigator: Anne Raben, Professor, Department of Nutrition, Sports and Exercise, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): August 20, 2018

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: B344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No