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Completed

NCT Number: NCT01927926

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Whey-protein & polydextrose snack

Dietary Supplement

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

Control Snack

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Mars, Inc.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 23, 2013
Registry last updated
Aug 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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