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Completed

NCT Number: NCT01615081

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

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

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, Faculty of Science, University of Copenhagen

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Acronym: Harboe

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2012
Registry last updated
Oct 5, 2012

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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