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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927926
• Other study ID #: A/5/2008
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: August 19, 2013
• Start date: May 2008
• Est. completion date: October 2008

Study information

• Verified date: August 2013
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Whey-protein & polydextrose snack
Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.
• Control snack
Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Mars, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolic responses	Blood samples will be collected in response to the snack bars on day 1 and analyzed for glucose, insulin and ffa.	Day 1	No
Other	Metabolic responses	Blood samples will be collected in response to the snack bars on day 15 and analyzed for glucose, insulin and ffa.	Day 15	No
Other	Endocrine responses	Blood samples will be collected in response to the snack bars on day 1 and analyzed for GLP-1, PYY and ghrelin.	Day 1	No
Other	Endocrine responses	Blood samples will be collected in response to the snack bars on day 15 and analyzed for GLP-1, PYY and ghrelin.	Day 15	No
Primary	Energy intake at an ad libitum lunchtime test meal	Energy intake at a lunchtime test meal served 90 min following the consumption of the snack bar on day 1.	Day 1	No
Secondary	Energy intake at an ad libitum lunchtime test meal	Energy intake at a lunchtime test meal served 90 min following the consumption of the snack bar on day 15.	Day 15	No
Secondary	Subjective appetite responses	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	No
Secondary	Remainder of the day energy intake	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	No
Secondary	Free living energy intake	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	No
Secondary	Free living energy intake	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	No
Secondary	Free living energy intake	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	No
Secondary	Subjective appetite responses	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	No
Secondary	Remainder of the day energy intake	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	No