ObesityNCT01927926
The Effects of Consuming Whey Protein Polydextrose Snacks on Appetite and Energy Intake
A study testing Whey-protein & polydextrose snack in people with Obesity, run by University of Nottingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Whey-protein & polydextrose snack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-25 kg/m2
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Whey-protein & polydextrose snack, Control snack
- Keywords
- Energy intake, appetite, satiety, gut hormones
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey-protein & polydextrose snackDietary supplement
Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.
Control snackDietary supplement
Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Whey-protein & polydextrose snack | Experimental | Whey-protein \& polydextrose snack bar. Receives: Dietary Supplement: Whey-protein & polydextrose snack |
| Control snack | Placebo comparator | Control snack bar containing minimal protein and not polydextrose. Receives: Dietary Supplement: Control snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (8)
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.
Measured: Day 15
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 4
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.
Measured: Day 8
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.
Measured: Day 12
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.
Measured: Day 15
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.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startMay 2008
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Mars, Inc.
- Responsible party
- Sponsor
- Investigators
- Ian A Macdonald, Phd, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927926
- Sponsor's protocol ID
- A/5/2008
- Status last verified
- Aug 2013
- First submitted
- 14 Aug 2013
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Astbury NM, Taylor MA, French SJ, Macdonald IA. Snacks containing whey protein and polydextrose induce a sustained reduction in daily energy intake over 2 wk under free-living conditions. Am J Clin Nutr. 2014 May;99(5):1131-40. doi: 10.3945/ajcn.113.075978. Epub 2014 Mar 26.
PubMed 24670946
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Consuming Between- Meal, High Protein Polydextrose Containing Snack Bars on Subjective Satiety, Energy Intake and Metabolic Responses.
- ClinicalTrials.gov ID
- NCT01927926
- Acronym / sponsor ID
- A/5/2008
- Conditions
- Obesity
- Keywords
- Energy intake, appetite, satiety, gut hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- May 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey-protein & polydextrose snack | Experimental | Dietary Supplement: Whey-protein & polydextrose snackWhey-protein \& polydextrose snack bar. |
| Control snack | Placebo comparator | Dietary Supplement: Control snackControl snack bar containing minimal protein and not polydextrose. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 18-25 kg/m2
Key exclusion criteria (6 listed)
- Smokers
- BMI <18 > 25 kg/m2
- Dieting or weight loss
- Presence of disease (e.g. diabetes, cardiovascular disease, cancer etc)
- Currently regularly taking medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey-protein & polydextrose snackSubjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days. | Dietary supplement | Whey-protein & polydextrose snack |
| Control snackSubjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days. | Dietary supplement | Control snack |
Primary outcome
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.
8 secondary outcomes
Energy intake at an ad libitum lunchtime test meal
Time frame: Day 15
Subjective appetite responses
Time frame: Day 1
Remainder of the day energy intake
Time frame: Day 1
Free living energy intake
Time frame: Day 4
Free living energy intake
Time frame: Day 8
Free living energy intake
Time frame: Day 12
Subjective appetite responses
Time frame: Day 15
Remainder of the day energy intake
Time frame: Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Derived from this study: PubMed 24670946Astbury NM, Taylor MA, French SJ, Macdonald IA. Snacks containing whey protein and polydextrose induce a sustained reduction in daily energy intake over 2 wk under free-living conditions. Am J Clin Nutr. 2014 May;99(5):1131-40. doi: 10.3945/ajcn.113.075978. Epub 2014 Mar 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian A Macdonald, Phd principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey-protein & polydextrose snack in people with Obesity, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake at an ad libitum lunchtime test meal (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01927926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.