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

NCT01615081 | Completed

• 1 other identifier: B287
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.3-hour change in the concentration of glucose and insulin
2. 2.3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)
3. 3.Ad libitum energy intake

Conditions

Obesity; Diabetes

Keywords

Malt extract; carbohydrate; glucose response; insulin response; Appetite; Appetite regulating hormones

Outcome Measures

Primary Outcomes (1)

• Acute 3-h changes from baseline in the postprandial concentration of glucose

  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 Outcomes (7)

• Acute 3-h changes from baseline in the postprandial concentration of 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

  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

  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

  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

  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)

Study Arms (2)

Sucrose solution

ACTIVE COMPARATOR

75 g sucrose (75 g carbohydrate) desolved in 750 ml water

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

Malt extract solution

EXPERIMENTAL

183 g malt extract (corresponding to 75 g carbohydrate and 103 ml water) desolved in 647 ml water

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

Interventions

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.

Malt extract solution; Sucrose solution

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy,
• BMI: 18.5-24.9 kg/m2,
• Non-smoking,
• Nonathletic (\< 10 h hard physical activity),

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

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

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Anne B Raben, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr Med

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 5, 2012

Record last verified: 2012-10

Locations

DK (1)