The Acute Effect of Malt Extract Versus Sucrose on the Response of Glucose and Insulin, Subjective Appetite Sensations and ad Libitum Energy Intake (Harboe)

October 4, 2012 updated by: AAstrup, University of Copenhagen

Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with other composition and amount of carbohydrates could be of interest in order to decrease the glucose and insulin responses after intake of a sweetened beverage/food. Malt extract has a sweet flavor but contains a different composition and amount of carbohydrates together with a small amount of protein compared to sucrose. Malt extract may therefore be a better alternative than sucrose as a sweetener due to a lower increase and more sustained blood glucose level. This could be of interest in relation to diabetes and appetite regulation but this is yet to be investigated.

Thus the objective is to investigate the effect of malt extract vs. sucrose on:

  1. 3-hour change in the concentration of glucose and insulin
  2. 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)
  3. Ad libitum energy intake

Design: 20 men will participate in the 2-way, randomized, double-blind crossover study. The test drinks is isocaloric with 75 g carbohydrates Test drinks: malt extract solution and sucrose solution (10%) Three-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Frederiksberg, Denmark, 1958
        • Department of Human Nutrition, Faculty of Science, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy,
  • BMI: 18.5-24.9 kg/m2,
  • Weight stable (within +/- 3 kg) two months prior to study inclusion,
  • Non-smoking,
  • Nonathletic (< 10 h hard physical activity),

Exclusion Criteria:

  • BMI > 25 kg/m2,
  • Change in smoking status,
  • Daily or frequent use of medication,
  • Suffering from metabolic diseases,
  • Suffering from psychiatric diseases,
  • Suffering from any other clinical condition, which would make the subject unfit to participate in the study,
  • Hemoglobin < 7.5 mmol/l.
  • alcohol and drug abuse
  • blood donation, 3mo prior to the present study and during study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sucrose solution
75 g sucrose (75 g carbohydrate) desolved in 750 ml water
2-arm crossover study for investigation of the effect of malt extract vs. sucrose on glucose, insulin, subjective appetite sensations and ad libitum energy intake.
EXPERIMENTAL: Malt extract solution
183 g malt extract (corresponding to 75 g carbohydrate and 103 ml water) desolved in 647 ml water
2-arm crossover study for investigation of the effect of malt extract vs. sucrose on glucose, insulin, subjective appetite sensations and ad libitum energy intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute 3-h changes from baseline in the postprandial concentration of glucose
Time Frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day glucose is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Blood samples are taken prior to the test drink (baseline). After initiation of the test drink blood samples are collected at time 15, 30, 45, 60, 90, 120, 150, 180 minutes. Blood samples are analyzed for glucose.
Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day glucose is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute 3-h changes from baseline in the postprandial concentration of insulin
Time Frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day insulin is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Blood samples are taken prior to the test drink(baseline). After initiation of the test drink blood samples are collected at time 15, 30, 45, 60, 90, 120, 150, 180 minutes. Blood samples are analyzed for insulin.
Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day insulin is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales
Time Frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day appetite sensations are measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake

Assessment of subjective appetite sensations (visual analogue scales (VAS)) at time 0 (baseline - prior to the test meal) and at time 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake.

Measured subjective appetite sensations of hunger, satiety, prospective consumption, fullness, composite appetite score and sensory desires to something sweet, salty, rich in fat, or meat/fish.

Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day appetite sensations are measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Rating of the organoleptic quality of the test drinks
Time Frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the test drink (approximately) time 5 minutes post intake) subjects will rate the test drink
After completion of the test drink the subjects will rate the organoleptic quality of the drink by visual analogue scales (VAS) in regard to appearance, smell, taste, after-taste, and general palatability.
Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the test drink (approximately) time 5 minutes post intake) subjects will rate the test drink
Rating of the organoleptic quality of the ad libitum meal
Time Frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the ad libitum meal (approximately) time 15-20 minutes post intake) subjects will rate the ad libitum meal
After completion of the adlibitum meal the subjects will rate the organoleptic quality of the meal by visual analogue scales (VAS) in regard to appearance, smell, taste, after-taste, and general palatability.
Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the ad libitum meal (approximately) time 15-20 minutes post intake) subjects will rate the ad libitum meal
Subjective appetite sensations (visual analogue scales) after ad libitum meal
Time Frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. After completion of the ad libitum meal subjects will rate their subjective sensation of appetite (approx 3.5-h post intake of test drink)
After completion of the ad libitum meal the subjects will rate the subjective appetite sensations by visual analogue scales (VAS) in regard to sensation of hunger, satiety, prospective consumption, fullness, composite appetite score and sensory desires to eat something sweet, salty, rich in fat, or meat/fish.
Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. After completion of the ad libitum meal subjects will rate their subjective sensation of appetite (approx 3.5-h post intake of test drink)
change in body weight and composition (fat mass and fat free mass)
Time Frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day body weight and composition is carried out prior to the test.
body weight will be measured to the nearest 0.05 kg on a decimal scale. Body composition will be assessed by electric bioimpedance using an Animeter.
Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day body weight and composition is carried out prior to the test.
ad libitum energy intake (EI)
Time Frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. EI was measured 180 min after intake of the test drink
180 min after each test drink an ad libitum meal was served, and the total energy intake was recorded
Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. EI was measured 180 min after intake of the test drink

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anne B Raben, Professor, Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (ESTIMATE)

June 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 5, 2012

Last Update Submitted That Met QC Criteria

October 4, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

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