SatietyNCT02246543
Whey Protein Study - Identification of Sustainable Satiety
A study testing HPL, LPL and HPS in people with Satiety, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Satiety
- What is being tested?
- HPL, LPL and HPS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Oct 2015
- 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 20 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI = 18.5-40kg/m2
Who cannot join
- Diabetes
- Severe gastrointestinal disorders
- Kidney disease
- Thromboembolic or coagulation disease
- Hepatic disease
- Alcohol or any other substance abuse
Show all 19Show fewer
- Gout
- Eating disorders
- Food allergy
- Unregulated thyroid disease
- Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders)
- Vegetarians \& Vegans
- Medication Exclusion Criteria:
- Orlistat (Xenical)
- Oral antidiabetics, insulin
- Rimonabant (Acomplia)
- Digoxin, anti-arrhythmics
- Sibutramine (Reductil)
- Tricyclic antidepressants, neuroleptics
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute of Nutrition & Health, University of Aberdeen
Aberdeen, Aberdeen City, AB21 9SB
About this study
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.
Read the detailed description
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
- Satiety
- Being tested
- Control, HPL, LPL, HPS, LPS
- Keywords
- Appetite, Gut Hormones, Protein, Energy Density, Gastric Emptying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Water, Toast \& Egg (Yolk only) + 0.1g 13C Octanoic Acid
HPLDietary supplement
High Protein Smoothie (Liquid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid
LPLDietary supplement
Low Protein Smoothie (Liquid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid
HPSDietary supplement
High Protein Milk Jelly (Solid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid
LPSDietary supplement
Low Protein Milk Jelly (Solid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 - Control | Placebo comparator | Water, Toast \& Egg (Yolk only) + 0.1g 13C Octanoic Acid Receives: Dietary Supplement: Control |
| Treatment 2 - HPL | Active comparator | High Protein Smoothie (Liquid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid Receives: Dietary Supplement: HPL |
| Treatment 3 - LPL | Active comparator | Low Protein Smoothie (Liquid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid Receives: 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 Receives: 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 Receives: Dietary Supplement: LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This is assessed using the 13C Octanoic Acid stable isotopic technique. A tracer is mixed into food and breath samples are collected which are analysed 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 CO2 is excreted into breath (12 samples will be collected during the 4hr test day).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startAug 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for SatietyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Johnstone, Dr, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246543
- Sponsor's protocol ID
- 2/033/13
- Other IDs
- 132033
- Status last verified
- Mar 2016
- First submitted
- 15 Sep 2014
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17700578Anderson 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.
PubMed 15514267Luhovyy 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.
PubMed 18187437Gustafson 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.
PubMed 11237351Burton-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.
PubMed 17964616DiMeglio 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.
PubMed 10878689Mattes RD. Beverages and positive energy balance: the menace is the medium. International Journal of Obesity 30: S60-S65, 2006.
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.
PubMed 18257753Ludwig 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.
PubMed 11229668Mourao 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.
PubMed 17579632Drewnowski 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.
PubMed 17344485Anderson 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.
PubMed 18065571Kissileff 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.
PubMed 6718557Kissileff 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.
PubMed 4061368Rolls 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.
PubMed 2268137
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whey Protein Study - Identification of Sustainable Satiety
- ClinicalTrials.gov ID
- NCT02246543
- Acronym / sponsor ID
- 2/033/13
- Conditions
- Satiety
- Keywords
- Appetite, Gut Hormones, Protein, Energy Density, Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Sep 2014 (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.
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
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 - Control | Placebo comparator | Dietary Supplement: ControlWater, Toast \& Egg (Yolk only) + 0.1g 13C Octanoic Acid |
| Treatment 2 - HPL | Active comparator | Dietary Supplement: HPLHigh Protein Smoothie (Liquid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid |
| Treatment 3 - LPL | Active comparator | Dietary Supplement: LPLLow Protein Smoothie (Liquid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid |
| Treatment 4 - HPS | Active comparator | Dietary Supplement: HPSHigh Protein Milk Jelly (Solid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid |
| Treatment 5 - LPS | Active comparator | Dietary Supplement: LPSLow Protein Milk Jelly (Solid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI = 18.5-40kg/m2
Key exclusion criteria (19 listed)
- Diabetes
- Severe gastrointestinal disorders
- Kidney disease
- Thromboembolic or coagulation disease
- Hepatic disease
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 |
|---|---|---|
| ControlWater, Toast \& Egg (Yolk only) + 0.1g 13C Octanoic Acid | Dietary supplement | Treatment 1 - Control |
| HPLHigh Protein Smoothie (Liquid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid | Dietary supplement | Treatment 2 - HPL |
| LPLLow Protein Smoothie (Liquid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid | Dietary supplement | Treatment 3 - LPL |
| HPSHigh Protein Milk Jelly (Solid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid | Dietary supplement | Treatment 4 - HPS |
| LPSLow Protein Milk Jelly (Solid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid | Dietary supplement | Treatment 5 - LPS |
Primary outcome
Changes in postprandial biomarkers of satiety as measured by gut-related hormones
Time frame: 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)
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.
1 secondary outcome
Changes in postprandial gastric emptying, measured using breath samples
Time frame: 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.
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 24 Mar 2016.
- Background: PubMed 17700578Bellissimo 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.
- Background: PubMed 15514267Anderson 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.
- Background: PubMed 18187437Luhovyy 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.
- Background: PubMed 11237351Gustafson 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.
- Background: PubMed 17964616Burton-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.
- Background: PubMed 10878689DiMeglio 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.
- BackgroundMattes RD. Beverages and positive energy balance: the menace is the medium. International Journal of Obesity 30: S60-S65, 2006.
- Background: PubMed 18257753Wolf 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.
- Background: PubMed 11229668Ludwig 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.
- Background: PubMed 17579632Mourao 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.
- Background: PubMed 17344485Drewnowski 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.
- Background: PubMed 18065571Anderson 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.
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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.
Alexandra Johnstone, Dr principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPL, LPL and HPS in people with Satiety, run by University of Aberdeen 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 19 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 24 Mar 2016. 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?
Changes in postprandial biomarkers of satiety as measured by gut-related hormones (time frame: 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)). 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 NCT02246543, which also lists 19 linked publications.
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 24 Mar 2016.