- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01927926
The Effects of Consuming Whey Protein Polydextrose Snacks on Appetite and Energy Intake
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nottingham, United Kingdom
- University of Nottingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A/5/2008
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