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

NCT ID: NCT03512509

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2018-08-20

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

A

Low glycaemic potato

Group Type: EXPERIMENTAL

Low glycaemic potato

Intervention Type: OTHER

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

B

High glycaemic potato

Group Type: EXPERIMENTAL

High glycaemic potato

Intervention Type: OTHER

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

Interventions

Low glycaemic potato

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

Intervention Type: OTHER

High glycaemic potato

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anne Birgitte Raben

OTHER

Sponsor Role: lead

Responsible Party

Anne Birgitte Raben

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anne Raben, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Sports and Exercise, University of Copenhagen

Locations

University of Copenhagen

Frederiksberg, , Denmark

Countries

Denmark

Other Identifiers

B344

Identifier Type: -

Identifier Source: org_study_id