NCT02246543

Brief Summary

This study will have the primary aim to investigate within-day changes in appetite after consumption of high-protein (HP, 30% of calories) and normal, or low, protein (LP, 15% of calories) whey protein meal, in solid and liquid form, on appetite and ad libitum food intake. Secondary objective will be to assess the statistical relationship between plasma concentrations of gut hormones and visual analogue scales (subjective hunger and fullness) and transit time. In order to investigate the interaction of food structure and protein content on appetite, this requires, in practice, either a differing amount (g) or calorie (kJ) load as a function of energy density (defined as kJ/100g). Delivering the test meal as a solid and liquid form gives an easy solution to achieve this manipulation without compromising the nutritional profile. Following on from this decision, it is easier to produce different preloads using whey protein (rather than meat protein), since it is easily incorporated into test meals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

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

August 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

September 15, 2014

Last Update Submit

March 23, 2016

Conditions

Satiety

Keywords

AppetiteGut HormonesProteinEnergy DensityGastric Emptying

Outcome Measures

Primary Outcomes (1)

  • Changes in postprandial biomarkers of satiety as measured by gut-related hormones

    The biomarkers to be measured on the Luminex system are Ghrelin (active), Glucagon-like peptide (GLP1), Peptide YY (PYY), Amylin, Leptin \& Insulin Biomarkers of Cardiovascular Disease (CVD) risk including total cholesterol, Low Density Lipoprotein Cholesterol (LDL), High Density Lipoprotein (HDL), triglycerides, nonesterified fatty acids (NEFA) will also be measured along with assessment of peripheral glycaemic control, fasting glucose, area under the curve combined with insulin data.

    On each test day blood samples are collected every 10 min for the first half hour, every 15 min for the second half hour and every 30mins subsequently. (Eight samples are therefore collected for 2hours at T0, T10, T20, T30, T45, T60, T90 and T120mins)

Secondary Outcomes (1)

  • Changes in postprandial gastric emptying, measured using breath samples

    On each test day samples are collected every 15mins for the first 2½hrs then every 30mins for the last ½hr. Therefore samples are collected for a total of 3hours at T0, T15, T30, T45, T60, T75, T90, T105, T120, T135, T150 and T180mins.

Other Outcomes (2)

  • Changes in subjective appetite using visual analogue scales

    On each test day the appetite questions are answered every 30mins during the 4hour visit.

  • Ad libitum food intake

    Recorded at T240mins on the test day visit and then for approximately 12hours at home. Therefore all food consumed during the 24hours of the test day will be assessed

Study Arms (5)

Treatment 1 - Control

PLACEBO COMPARATOR

Water, Toast \& Egg (Yolk only) + 0.1g 13C Octanoic Acid

Dietary Supplement: Control

Treatment 2 - HPL

ACTIVE COMPARATOR

High Protein Smoothie (Liquid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid

Dietary Supplement: HPL

Treatment 3 - LPL

ACTIVE COMPARATOR

Low Protein Smoothie (Liquid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid

Dietary Supplement: LPL

Treatment 4 - HPS

ACTIVE COMPARATOR

High Protein Milk Jelly (Solid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid

Dietary Supplement: HPS

Treatment 5 - LPS

ACTIVE COMPARATOR

Low Protein Milk Jelly (Solid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid

Dietary Supplement: LPS

Interventions

ControlDIETARY_SUPPLEMENT

Water, Toast \& Egg (Yolk only) + 0.1g 13C Octanoic Acid

Treatment 1 - Control
HPLDIETARY_SUPPLEMENT

High Protein Smoothie (Liquid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid

Treatment 2 - HPL
LPLDIETARY_SUPPLEMENT

Low Protein Smoothie (Liquid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid

Treatment 3 - LPL
HPSDIETARY_SUPPLEMENT

High Protein Milk Jelly (Solid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid

Treatment 4 - HPS
LPSDIETARY_SUPPLEMENT

Low Protein Milk Jelly (Solid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid

Treatment 5 - LPS

Eligibility Criteria

Age20 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI = 18.5-40kg/m2

You may not qualify if:

  • Diabetes
  • Severe gastrointestinal disorders
  • Kidney disease
  • Thromboembolic or coagulation disease
  • Hepatic disease
  • Alcohol or any other substance abuse
  • Gout
  • Eating disorders
  • Food allergy
  • Unregulated thyroid disease
  • Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders)
  • Vegetarians \& Vegans
  • Orlistat (Xenical)
  • Oral antidiabetics, insulin
  • Rimonabant (Acomplia)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowett Institute of Nutrition & Health, University of Aberdeen

Aberdeen, Aberdeen City, AB21 9SB, United Kingdom

Location

Related Publications (19)

  • Bellissimo N, Desantadina MV, Pencharz PB, Berall GB, Thomas SG, Anderson GH. A comparison of short-term appetite and energy intakes in normal weight and obese boys following glucose and whey-protein drinks. Int J Obes (Lond). 2008 Feb;32(2):362-71. doi: 10.1038/sj.ijo.0803709. Epub 2007 Aug 14.

    PMID: 17700578BACKGROUND

  • Anderson GH, Tecimer SN, Shah D, Zafar TA. Protein source, quantity, and time of consumption determine the effect of proteins on short-term food intake in young men. J Nutr. 2004 Nov;134(11):3011-5. doi: 10.1093/jn/134.11.3011.

    PMID: 15514267BACKGROUND

  • Luhovyy BL, Akhavan T, Anderson GH. Whey proteins in the regulation of food intake and satiety. J Am Coll Nutr. 2007 Dec;26(6):704S-12S. doi: 10.1080/07315724.2007.10719651.

    PMID: 18187437BACKGROUND

  • Gustafson DR, McMahon DJ, Morrey J, Nan R. Appetite is not influenced by a unique milk peptide: caseinomacropeptide (CMP). Appetite. 2001 Apr;36(2):157-63. doi: 10.1006/appe.2000.0392.

    PMID: 11237351BACKGROUND

  • Burton-Freeman BM. Glycomacropeptide (GMP) is not critical to whey-induced satiety, but may have a unique role in energy intake regulation through cholecystokinin (CCK). Physiol Behav. 2008 Jan 28;93(1-2):379-87. doi: 10.1016/j.physbeh.2007.09.010. Epub 2007 Oct 26.

    PMID: 17964616BACKGROUND

  • DiMeglio DP, Mattes RD. Liquid versus solid carbohydrate: effects on food intake and body weight. Int J Obes Relat Metab Disord. 2000 Jun;24(6):794-800. doi: 10.1038/sj.ijo.0801229.

    PMID: 10878689BACKGROUND

  • Mattes RD. Beverages and positive energy balance: the menace is the medium. International Journal of Obesity 30: S60-S65, 2006.

    BACKGROUND

  • Wolf A, Bray GA, Popkin BM. A short history of beverages and how our body treats them. Obes Rev. 2008 Mar;9(2):151-64. doi: 10.1111/j.1467-789X.2007.00389.x.

    PMID: 18257753BACKGROUND

  • Ludwig DS, Peterson KE, Gortmaker SL. Relation between consumption of sugar-sweetened drinks and childhood obesity: a prospective, observational analysis. Lancet. 2001 Feb 17;357(9255):505-8. doi: 10.1016/S0140-6736(00)04041-1.

    PMID: 11229668BACKGROUND

  • Mourao DM, Bressan J, Campbell WW, Mattes RD. Effects of food form on appetite and energy intake in lean and obese young adults. Int J Obes (Lond). 2007 Nov;31(11):1688-95. doi: 10.1038/sj.ijo.0803667. Epub 2007 Jun 19.

    PMID: 17579632BACKGROUND

  • Drewnowski A, Bellisle F. Liquid calories, sugar, and body weight. Am J Clin Nutr. 2007 Mar;85(3):651-61. doi: 10.1093/ajcn/85.3.651.

    PMID: 17344485BACKGROUND

  • Anderson GH. Much ado about high-fructose corn syrup in beverages: the meat of the matter. Am J Clin Nutr. 2007 Dec;86(6):1577-8. doi: 10.1093/ajcn/86.5.1577. No abstract available.

    PMID: 18065571BACKGROUND

  • Kissileff HR, Gruss LP, Thornton J, Jordan HA. The satiating efficiency of foods. Physiol Behav. 1984 Feb;32(2):319-32. doi: 10.1016/0031-9384(84)90147-1.

    PMID: 6718557BACKGROUND

  • Kissileff HR. Effects of physical state (liquid-solid) of foods on food intake: procedural and substantive contributions. Am J Clin Nutr. 1985 Nov;42(5 Suppl):956-65. doi: 10.1093/ajcn/42.5.956.

    PMID: 4061368BACKGROUND

  • Rolls BJ, Fedoroff IC, Guthrie JF, Laster LJ. Foods with different satiating effects in humans. Appetite. 1990 Oct;15(2):115-26. doi: 10.1016/0195-6663(90)90044-9.

    PMID: 2268137BACKGROUND

  • Akhavan T, Luhovyy BL, Anderson GH. Effect of drinking compared with eating sugars or whey protein on short-term appetite and food intake. Int J Obes (Lond). 2011 Apr;35(4):562-9. doi: 10.1038/ijo.2010.163. Epub 2010 Aug 24.

    PMID: 20733582BACKGROUND

  • Westerterp-Plantenga MS, Lejeune MP, Nijs I, van Ooijen M, Kovacs EM. High protein intake sustains weight maintenance after body weight loss in humans. Int J Obes Relat Metab Disord. 2004 Jan;28(1):57-64. doi: 10.1038/sj.ijo.0802461.

    PMID: 14710168BACKGROUND

  • Weigle DS, Breen PA, Matthys CC, Callahan HS, Meeuws KE, Burden VR, Purnell JQ. A high-protein diet induces sustained reductions in appetite, ad libitum caloric intake, and body weight despite compensatory changes in diurnal plasma leptin and ghrelin concentrations. Am J Clin Nutr. 2005 Jul;82(1):41-8. doi: 10.1093/ajcn.82.1.41.

    PMID: 16002798BACKGROUND

  • Lacroix M, Mosora F, Pontus M, Lefebvre P, Luyckz A, Lopez-Habib G. Glucose naturally labeled with carbon-13: use for metabolic studies in man. Science. 1973 Aug 3;181(4098):445-6. doi: 10.1126/science.181.4098.445.

    PMID: 4718109BACKGROUND

Study Officials

  • Alexandra Johnstone, Dr

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 22, 2014

Study Start

August 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 24, 2016

Record last verified: 2016-03

Locations

GB(1)