Effects of consuming preloads which differ in energy density (low vs. high) and taste quality (savoury vs. sweet) on postprandial glucose response and energy compensation

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001128482
• Date of registration: 18/08/2016
• Prospective Registration: No
• Primary sponsor: Singapore Institute for Clinical Sciences, A*STAR
• Public title: Effects of consuming preloads which differ in energy density (low vs. high) and taste quality (savoury vs. sweet) on postprandial glucose response and energy compensation
• Scientific title: A randomised crossover intervention to compare the effects of consuming preloads which differ in energy density (low vs. high) and taste quality (savoury vs. sweet) on postprandial glucose response and energy compensation in healthy males
• Date of first enrolment: 08/08/2016
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616001128482.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;

Countries of recruitment

Singapore

Contacts

• Name: Dr Agnes Siew Ling Tey

• Name: Dr Agnes Siew Ling Tey

Key inclusion & exclusion criteria

Inclusion criteria: The inclusion criteria for this study are healthy males aged between 21 and 50 years with normal BMI (18.5 to 25.0 kg/m2).
Exclusion criteria: The exclusion criteria are as follows,
(a) People with major chronic disease such as heart disease, cancer or diabetes mellitus
(b) Individuals whose body weight has changed more than 5 kilograms in the last 12 months
(c) People who are taking insulin or medications known to affect glucose metabolism, appetite or energy metabolism
(d) Individuals who are currently dieting
(e) People with intolerance or allergy to study foods

Age minimum: 21 Years
Age maximum: 50 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Obesity

Metabolic and Endocrine - Diabetes

Obesity ;Diabetes;
Obesity

Diabetes

Intervention(s)

This study will be conducted using a randomised crossover design with four treatments: low energy dense savoury preload (around 50 kcal with monosodium glutamate (MSG) and inosine 5’-monophosphate (IMP)), low energy dense sweet preload (around 50 kcal with sucralose), high energy dense savoury preload (around 250 kcal with MSG and IMP), and high energy dense sweet preload (around 250 kcal with sucralose).

All potential participants will be asked to attend a screening session after a 10-hour overnight fast for consenting and screening procedures. Some basic anthropometric measurements such as height, weight, waist and hip circumferences will be taken. Body composition will be measured using Tanita BC-418 machine and BODPOD. Blood pressure will be taken using an automated blood pressure monitor. After the screening visit, participants will be asked to attend four test sessions, with a minimum of five-day washout period between the test sessions.

On each test day, participants will be asked to consume a pre-package study breakfast outside Clinical Nutrition Research Centre (CNRC) between 8 am and 9 am. The study breakfast consists of a packet of Milo, an apple, a packet of biscuit, and a muesli bar. Participants will be asked to arrive at CNRC three hours after breakfast (between 11 am and 12 pm), where they will be provided with a study preload which must be consumed within a 15-minute time period. The preload is made up of soup with ingredients such as yam, sweet potato, corn, and snow fungus. Participants will be provided with an ad libitum lunch an hour after the commencement of preload consumption, where they are allowed to consume as much or as little as they wish until they feel comfortably full. Food consumption will be supervised by research staff.

Primary Outcome(s)

Energy compensation, i.e. energy intake during an ad libitum lunch meal. Ad libitum intake of the lunch meal will be measured by weighing the leftovers on the plate. Energy compensation will then be calculated. [Ad libitum lunch. On each test day, participants will be asked to consume a study preload in mid-morning and they will be provided with an ad libitum lunch an hour later, where they are allowed to consume as much or as little food as they wish until they feel comfortably full.]

Blood glucose response. Fingerprick blood samples will be obtained prospectively for blood glucose measurement. Blood samples will be collected directly into cuvettes for analysing blood glucose concentrations using a Hemocue Glucose 201 Analyser (Helsinborg, Sweden).[Fingerprick blood samples will be collected at baseline (prior to preload consumption), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, and 180 minutes after commencement of preload consumption.]

Secondary Outcome(s)

Questionnaires on individual characteristics, food choice and preference (Composite) will be used to determine whether the degree of energy compensation could be explained by these variables. These questionnaires will include Dutch Eating Behaviour Questionnaire, Three Factor Eating Questionnaire, Body Perception Questionnaire, Intuitive Eating Scale, Dietary Practice Questionnaire, Food Choice Questionnaire, Food Preference Questionnaire, and Power of Food Scale.[Participants will be asked to complete the questionnaires at baseline.]

Satiety response. During each test session, participants will be asked to record their appetite (e.g. hunger, thirst, desire to eat, prospective consumption, fullness, etc.) on a 100 mm visual analogue scale. [Participants will be asked to rate their appetite every 15 minutes for the first hour after commencement of preload consumption and every 30 minutes for the subsequent two hours, nine timepoints in total. ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Singapore Institute for Clinical Sciences, A*STAR

Ethics review

Status: Approved
Approval date:
Contact:

Singapore National Healthcare Group Domain Specific Review Board