Whey Protein Study - Identification of Sustainable Satiety

NCT ID: NCT02246543

Last Updated: 2016-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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A randomized crossover design in 10 overweight/obese (BMI 26-40) men and 10 lean men (BMI 18.5-25). The control will be water. Each subject will attend the HNU on six separate occasions. The five test meal challenges will involve subjects attending the Human Nutrition Unit (HNU) in the morning, after an overnight fast. The total time of test meal visits will be approximately 4½hours. They will be provided with a standardised meal, after which blood samples will be collected for the first 2hrs. The following five treatments will be tested:

Treatment 1 Control - Water + Egg Yolk Mixture + 13C Octanoic Acid Treatment 2 HPL (High Protein Liquid): 30% protein; 30% fat and 40% carbohydrate (CHO) Treatment 3 LPL (Low Protein Liquid): 15% protein; 30% fat and 55% CHO Treatment 4 HPS (High Protein Solid): 30% protein; 30% fat and 40% CHO Treatment 5 LPS (Low Protein Solid): 15% protein; 30% fat and 55% CHO Test meals will be of fixed nutritional composition for all participants. The liquid meal will be a milk/fruit smoothie mixture and the 'solid' will be in a milk jelly (set) form.

Ad libitum pasta meal: 15% protein; 30% fat and 55% CHO as a homogenous mix and energy density of around 400kJ/100g - served in excess as a individual 600g portion to 'help-yourself'.

Subjective average appetite will be measured (every 30 min by visual analogue scales) over 4hr and ad libitum food intake will measured 4hr after treatment consumption. Ad libitum lunch will be a homogenous pasta meal with tomato sauce and a bottle of water. Blood samples will be collected every 10 min for the first half hour, every 15 min for the second half hour and every 30mins subsequently. The breath gastric emptying measurement will be assessed using the 13Carbon (13C) Octanoic Acid stable isotopic technique19. This involves mixing the tracer into food and taking breath samples and measured by isotope ratio mass spectrometry. 13C Octanoic acid is a medium chain fatty acid which is rapidly absorbed in the duodenum and metabolised in the liver. Following oxidation, the resulting Carbon Dioxide (CO2) is excreted into breath (12 samples will be collected during the 4hr test day).

Conditions

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Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment 1 - Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

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

Treatment 2 - HPL

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

Group Type ACTIVE_COMPARATOR

HPL

Intervention Type DIETARY_SUPPLEMENT

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

Treatment 3 - LPL

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

Group Type ACTIVE_COMPARATOR

LPL

Intervention Type DIETARY_SUPPLEMENT

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

Treatment 4 - HPS

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

Group Type ACTIVE_COMPARATOR

HPS

Intervention Type DIETARY_SUPPLEMENT

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

Treatment 5 - LPS

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

Group Type ACTIVE_COMPARATOR

LPS

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Control

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

Intervention Type DIETARY_SUPPLEMENT

HPL

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

Intervention Type DIETARY_SUPPLEMENT

LPL

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

Intervention Type DIETARY_SUPPLEMENT

HPS

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

Intervention Type DIETARY_SUPPLEMENT

LPS

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI = 18.5-40kg/m2

Exclusion Criteria

* 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)
* Digoxin, anti-arrhythmics
* Sibutramine (Reductil)
* Tricyclic antidepressants, neuroleptics
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandra Johnstone, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

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Rowett Institute of Nutrition & Health, University of Aberdeen

Aberdeen, Aberdeen City, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 17700578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15514267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18187437 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11237351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17964616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10878689 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 18257753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11229668 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17579632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17344485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18065571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6718557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4061368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2268137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20733582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14710168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16002798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4718109 (View on PubMed)

Other Identifiers

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132033

Identifier Type: OTHER

Identifier Source: secondary_id

2/033/13

Identifier Type: -

Identifier Source: org_study_id

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