The Effects of Consuming Whey Protein Polydextrose Snacks on Appetite and Energy Intake

August 19, 2013 updated by: University of Nottingham

The Effects of Consuming Between- Meal, High Protein Polydextrose Containing Snack Bars on Subjective Satiety, Energy Intake and Metabolic Responses.

Developing functional foods that enhance satiety may be beneficial to individuals to help manage body weight.

We have previously shown that consuming a mid-morning liquid preload with increasing proportion of energy derived from whey protein and addition of polydextrose reduced voluntary energy intake at a lunchtime meal compared to a liquid preload of the same energy content but lower in protein and containing no polydextrose.

This study aims to investigate if these results can be replicated when the preload is in the form of a snack bar. We will also investigate whether the daily consumption of the snack bar has an effect on energy intake, subjective appetite and metabolic parameters compared to a control snack of the same energy but with a minimal protein content and without the addition of polydextrose.

We hypothesize that the whey protein polydextrose snack will reduce voluntary energy intake at a subsequent test meal, suppress subjective appetite ratings compared with the control snack bar.

Study Overview

Detailed Description

Background:

Developing functional food products that enhance satiety, suppress appetite, and reduce subsequent voluntary food intake to a greater extent than a similar energy matched food product, may be useful to help consumers adhere to energy restricted diets and optimize successful body weight management. A range of foods and food constituents have been reported to have the potential to produce short term changes in appetite and energy intake. However, the effects of consuming foods containing such ingredients on appetite, energy intake over the longer term is unclear.

We have previously shown that consuming a mid-morning liquid preload with increasing proportion of energy derived from whey protein and addition of polydextrose reduced voluntary energy intake at a lunchtime meal compared to a liquid preload of the same energy content but lower in protein and containing no polydextrose.

Aims:

This study aims to investigate if previous findings can be replicated using solid snack bars containing whey protein and polydextrose. We will also investigate whether the daily consumption of the snack bar has an effect on energy intake, subjective appetite and metabolic and endocrine responses.

Methods:

Using a double blind, randomized cross-over design, 10 healthy lean male subjects will consume a whey protein-polydextrose bar and an iso-energetic control bar as a mid-morning, between-meal snack for 14 consecutive days. The two intervention phases will be separated by a 2-wk washout period. On the first (day 1) and the last day (day 15) of each intervention phase, subjective appetite, voluntary food intake, blood metabolite and endocrine responses to the snacks will be assessed under laboratory conditions. Additionally, participants will be asked to record free-living food intake on days 4, 8 and 12 of the intervention.

Study Type

Interventional

Enrollment (Actual)

10

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

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

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI 18-25 kg/m2

Exclusion Criteria:

  • Smokers
  • BMI <18 > 25 kg/m2
  • Dieting or weight loss
  • Presence of disease (e.g. diabetes, cardiovascular disease, cancer etc)
  • Currently regularly taking medications
  • Restrained eaters (defined as restraint score >7 on TFEQ)

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whey-protein & polydextrose snack
Whey-protein & polydextrose snack bar.
Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.
Placebo Comparator: Control snack
Control snack bar containing minimal protein and not polydextrose.
Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy intake at an ad libitum lunchtime test meal
Time Frame: Day 1
Energy intake at a lunchtime test meal served 90 min following the consumption of the snack bar on day 1.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy intake at an ad libitum lunchtime test meal
Time Frame: Day 15
Energy intake at a lunchtime test meal served 90 min following the consumption of the snack bar on day 15.
Day 15
Subjective appetite responses
Time Frame: Day 1
Subjective appetite ratings (hunger, fullness, desire to eat, thirst and nausea) will be recorded when subjects arrive at the laboratory (fasting), prior to the consumption of the snack (-15min), immediately following the consumption of the snack (0 min) and at 30, 60 and 90 min later on day 1.
Day 1
Remainder of the day energy intake
Time Frame: Day 1

Subjects will record all foods and drinks consumed after they leave the laboratory, for the remainder of the day on day 1 in a food diary provided.

Total daily energy intake will be calculated from the sum of energy from foods consumed in the laboratory and foods and drinks recorded in the diary.

Day 1
Free living energy intake
Time Frame: Day 4
Subjects will record all foods and drinks consumed on day 4 of the free-living phase of the intervention in a food diary provided.
Day 4
Free living energy intake
Time Frame: Day 8
Subjects will record all foods and drinks consumed on day 8 of the free-living phase of the intervention in a food diary provided.
Day 8
Free living energy intake
Time Frame: Day 12
Subjects will record all foods and drinks consumed on day 12 of the free-living phase of the intervention in a food diary provided.
Day 12
Subjective appetite responses
Time Frame: Day 15
Subjective appetite ratings (hunger, fullness, desire to eat, thirst and nausea) will be recorded when subjects arrive at the laboratory (fasting), prior to the consumption of the snack (-15min), immediately following the consumption of the snack (0 min) and at 30, 60 and 90 min later on day 15.
Day 15
Remainder of the day energy intake
Time Frame: Day 15

Subjects will record all foods and drinks consumed after they leave the laboratory, for the remainder of the day on day 15 in a food diary provided.

Total daily energy intake will be calculated from the sum of energy from foods consumed in the laboratory and foods and drinks recorded in the diary.

Day 15

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic responses
Time Frame: Day 1
Blood samples will be collected in response to the snack bars on day 1 and analyzed for glucose, insulin and ffa.
Day 1
Metabolic responses
Time Frame: Day 15
Blood samples will be collected in response to the snack bars on day 15 and analyzed for glucose, insulin and ffa.
Day 15
Endocrine responses
Time Frame: Day 1
Blood samples will be collected in response to the snack bars on day 1 and analyzed for GLP-1, PYY and ghrelin.
Day 1
Endocrine responses
Time Frame: Day 15
Blood samples will be collected in response to the snack bars on day 15 and analyzed for GLP-1, PYY and ghrelin.
Day 15

Collaborators and Investigators

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

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 23, 2013

Study Record Updates

Last Update Posted (Estimate)

August 23, 2013

Last Update Submitted That Met QC Criteria

August 19, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • A/5/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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