NCT01927926

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

4 months

First QC Date

August 14, 2013

Last Update Submit

August 19, 2013

Conditions

Obesity

Keywords

Energy intakeappetitesatietygut hormones

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Energy intake at an ad libitum lunchtime test meal

    Day 15

  • Subjective appetite responses

    Day 1

  • Remainder of the day energy intake

    Day 1

  • Free living energy intake

    Day 4

  • Free living energy intake

    Day 8

  • +3 more secondary outcomes

Other Outcomes (4)

  • Metabolic responses

    Day 1

  • Metabolic responses

    Day 15

  • Endocrine responses

    Day 1

  • +1 more other outcomes

Study Arms (2)

Whey-protein & polydextrose snack

EXPERIMENTAL

Whey-protein \& polydextrose snack bar.

Dietary Supplement: Whey-protein & polydextrose snack

Control snack

PLACEBO COMPARATOR

Control snack bar containing minimal protein and not polydextrose.

Dietary Supplement: Control snack

Interventions

Whey-protein & polydextrose snackDIETARY_SUPPLEMENT

Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.

Whey-protein & polydextrose snack
Control snackDIETARY_SUPPLEMENT

Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.

Control snack

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18-25 kg/m2

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24670946DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Whey

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Ian A Macdonald, Phd

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 23, 2013

Study Start

May 1, 2008

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

August 23, 2013

Record last verified: 2013-08

Locations

GB(1)