ObesityALPROsoyaNCT02080325
Vegetarian High Protein Weight Loss Diets
A study testing High Protein-Weight loss-Soy diet and High Protein-Weight loss-Meat in people with Obesity, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This study aims to investigate the mechanistic processes involved in protein-induced satiety/satiation during weight loss in humans. Thsi study will investigate: How do high-protein weight loss (HPWL) diets rich in meat or soya based protein sources impact on profile of 'motivation to eat' both within a day and… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High Protein-Weight loss-Soy diet and High Protein-Weight loss-Meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Dec 2010
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Overweight or obese (BMI 27+ )
- With no existing medical conditions or medication that could influence appetite or mood.
Who cannot join
- Diabetes
- Severe gastrointestinal disorders
- Kidney disease
- Thromboembolic or coagulation disease
- Hepatic disease
- Alcohol or any other substance abuse
Show all 11Show fewer
- Gout
- Eating disorders
- Food allergy
- Unregulated thyroid disease
- Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, AB21 9SB
About this study
This study aims to investigate the mechanistic processes involved in protein-induced satiety/satiation during weight loss in humans.
Thsi study will investigate:
Read more
- How do high-protein weight loss (HPWL) diets rich in meat or soya based protein sources impact on profile of 'motivation to eat' both within a day and between days ?
- Do biomarkers of satiety alter differentially on meat or soya HPWL diet, as measured by monitoring alteration in plasma amino acids and gut-related hormones ?
- How does a vegetarian and meat-based weight loss diet impact on nitrosamine excretion in faecal samples, as an indicator of faecal toxicity?
Previous work has indicated that high-protein (30% protein) weight loss diets are more satiating (produce less hunger) than normal protein WL diet (15% protein) or a diet supplemented with few amino acids. In previous work, a mixed source of protein has been used, mainly from meat (beef, chicken, fish). These types of diets have been criticised because of the potential negative side effects, including our own work on gut health. It might be that alternative vegetable sources of protein could fulfil the diet remit, to be satiating and yet still allow weight loss, and maintain a healthy gut.
Design -within subject, randomised cross-over design after day 3. Each subject acts as their own control and will receive each treatment. 18-20 subjects to participate.
Length of time - Conduct the two nutritional interventions over a period of 14 days, in order to reduce effects due to an acute change in nutritional intake.
PROTOCOL Days 1- 3 - Normal Protein Maintenance diet (NP- MTD, 3 days)
- st ARM Days 4-17 - randomised to High Protein-Weight loss-Meat (HP-Soya,14 days),
- nd ARM Days 18-31 - randomised to High Protein-Weight loss-Soya (HP-meat,14 days),
Read the detailed description
From literature we know that:
- Within-day experiment feeding myco-protein (quorn) versus chicken at lunch resulted in an 18% reduction in evening meal ad libitum intake following the quorn meal (Burley, P. Blundell, 1993, Eur J Clin Nutr, 409-18).
- Feeding casein, soy, pea, wheat gluten, egg albumin, gelatin as part of a mixed meal had no influence on post-lunch satiety (Lang et al.,1998, Am J Clin Nutr., 1197-204).
- Varying protein source (soy, caseine, gelatin) at breakfast meal at 1.8 and 3.6MJ/meal had no impact on 24 hour energy or macronutrient intakes (Lang et al., 1999, Eur J Clin Nutr, 959-65).
- Comparison of mycoprotein and tofu to a chicken preload before lunch indicated that the vegetarian sources were associated with lower food intake at lunch (Williamson et al., 2006, Appetite, 41-8).
- Addition of 25g protein in a liquid format (whey and soy) led to suppression of food intake (pizza meal) 1 hour later, in comparison to water and whey preload.
It is noted that all of these studies, (i) were conducted over a short time period (within day), (ii) none were high-protein weight loss diets (low calorie, high protein), (iii) none compared mixed meat versus vegetable source. It is of interest from both a scientific and public health point of view whether meat and vegetarian sources of protein similarly impact on motivation to eat.
The diets for this study:
- The maintenance diet (MTD) (day 1 - 3) will consist of 15% protein, 30% fat and 55% carbohydrate fed to 1.5 x RMR (resting metabolic rate)
- The high protein (HP) weight loss diet will be fed to 100% resting metabolic rate (RMR) on a 5 day rotation menu, fed as three meals a day, 30% protein, 30% fat and 40% carbohydrate; the meat version will be based on chicken and beef meat; the soya version based on soya protein or soya-tvp (textured vegetable protein).
Soya protein is now widely available as milk (ALPRO), margarine (PURE), enhanced bread (BURGEN), sausages (GRANOSE), bacon (GRANOSE), burgers (GRANOSE), mince (GRANOSE), powered isolate, cheese, cream (SOYA DREAM), yoghurt (ALPRO), chicken-style fillets (GRASSINGTONS).
- Conditions
- Obesity
- Being tested
- High Protein-Weight loss-Soy diet, High Protein-Weight loss-Meat
- Keywords
- weight loss, high protein diet, plant protein, satiety, soy
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein-Weight loss-Soy dietOther
Also called SOY HP WL diet
- The high protein (HP) weight loss diet will be fed to 100% resting metabolic rate (RMR) on a 5 day rotation menu, fed as three meals a day, 30% protein, 30% fat and 40% carbohydrate; the soya version based on soya protein or soya-tvp (textured vegetable protein).
High Protein-Weight loss-MeatOther
Also called MEAT HP WL diet
- The high protein (HP) weight loss diet will be fed to 100% resting metabolic rate (RMR) on a 5 day rotation menu, fed as three meals a day, 30% protein, 30% fat and 40% carbohydrate; the meat version will be based on chicken and beef meat.
| Study group | Role | What they receive |
|---|---|---|
| High Protein-Weight loss-Meat/High Protein-Weight loss Soy | Other | After 3 Days - Normal Protein Maintenance diet (NP- MTD, 3 days), there is the first arm of the study, Days 14 days- randomised to High Protein-Weight loss-Meat with High Protein-Weight loss-Soy Receives: Other: High Protein-Weight loss-Soy diet; Other: High Protein-Weight loss-Meat |
| High Protein-Weight loss-Soya/High Protein Weight loss-meat | Other | After 3 Days - Normal Protein Maintenance diet (NP- MTD, 3 days), there is the first arm of the study, Days 14 days- randomised to High Protein-Weight loss-Soy with High Protein-Weight loss-Meat Receives: Other: High Protein-Weight loss-Soy diet; Other: High Protein-Weight loss-Meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
appetite control
- Motivation to eat (VAS) hourly during waking hours up to 6pm in the evening, collected on a hand-help computer
- Food diary
- End of day questionnaire on mood
Measured: Every day of the study: From day 1 to 32 inclusive
Secondary outcomes (1)
Satiety biomarkers- COMPOSITE MEASURE
- Subjects will undergo a nutritional challenge on days 4, 18 and 32, where they will attend the Human Nutrition Unit for a meal test (breakfast and lunch, separated by a 5 hr interval) with frequent blood sampling from a cannulae in the arm/hand. Total blood sample collection on each test day will be no more than 120ml per session, collected between 8am and 1pm. Blood samples will be used to measure plasma amino acid concentration, metabolites (e.g. lipids, glucose) and hormones relating to appetite (e.g. PYY). The meal test will consist of their standard meal from their menu.
- Body composition by bod pod, skinfolds and circumferences
- Two questionnaires - TFEI (Three-Factor Eating Inventory questionnaire)and DEBQ (Dutch Eating Behaviour) to assess influences on eating
- Resting metabolic rate using ventilated hood
- Blood pressure and pulse
Measured: test day (day 1, 4, 18, 32 of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra M Johnstone, PhD, Principal investigator, Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, Scotland, UK,Wendy R Russell, PhD, Principal investigator, Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, Scotland, UK,Silvia Gratz, PhD, Principal investigator, Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, Scotland, UK,Graham Horgan, PhD, Principal investigator, Biomathematics and Statistics Scotland, Aberdeen, Scotland, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080325
- Sponsor's protocol ID
- 783 Soya
- Other IDs
- ALPRO™ Foundation
- Acronym
- ALPROsoya
- Status last verified
- Mar 2014
- First submitted
- 28 Feb 2014
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Neacsu M, Fyfe C, Horgan G, Johnstone AM. Appetite control and biomarkers of satiety with vegetarian (soy) and meat-based high-protein diets for weight loss in obese men: a randomized crossover trial. Am J Clin Nutr. 2014 Aug;100(2):548-58. doi: 10.3945/ajcn.113.077503. Epub 2014 Jun 18.
PubMed 24944057
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vegetarian High Protein Weight Loss Diets
- ClinicalTrials.gov ID
- NCT02080325
- Acronym / sponsor ID
- ALPROsoya / 783 Soya
- Conditions
- Obesity
- Keywords
- weight loss, high protein diet, plant protein, satiety, soy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Mar 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 aims to investigate the mechanistic processes involved in protein-induced satiety/satiation during weight loss in humans.
Thsi study will investigate:
- How do high-protein weight loss (HPWL) diets rich in meat or soya based protein sources impact on profile of 'motivation to eat' both within a day and between days ?
- Do biomarkers of satiety alter differentially on meat or soya HPWL diet, as measured by monitoring alteration in plasma amino acids and gut-related hormones ?
- How does a vegetarian and meat-based weight loss diet impact on nitrosamine excretion in faecal samples, as an indicator of faecal toxicity?
Previous work has indicated that high-protein (30% protein) weight loss diets are more satiating (produce less hunger) than normal protein WL diet (15% protein) or a diet supplemented with few amino acids. In previous work, a mixed source of protein has been used, mainly from meat (beef, chicken, fish). These types of diets have been criticised because of the potential negative side effects, including our own work on gut health. It might be that alternative vegetable sources of protein could fulfil the diet remit, to be satiating and yet still allow weight loss, and maintain a healthy gut.
Design -within subject, randomised cross-over design after day 3. Each subject acts as their own control and will receive each treatment. 18-20 subjects to participate.
Length of time - Conduct the two nutritional interventions over a period of 14 days, in order to reduce effects due to an acute change in nutritional intake.
PROTOCOL Days 1- 3 - Normal Protein Maintenance diet (NP- MTD, 3 days)
- st ARM Days 4-17 - randomised to High Protein-Weight loss-Meat (HP-Soya,14 days),
- nd ARM Days 18-31 - randomised to High Protein-Weight loss-Soya (HP-meat,14 days),
Detailed description
From literature we know that:
- Within-day experiment feeding myco-protein (quorn) versus chicken at lunch resulted in an 18% reduction in evening meal ad libitum intake following the quorn meal (Burley, P. Blundell, 1993, Eur J Clin Nutr, 409-18).
- Feeding casein, soy, pea, wheat gluten, egg albumin, gelatin as part of a mixed meal had no influence on post-lunch satiety (Lang et al.,1998, Am J Clin Nutr., 1197-204).
- Varying protein source (soy, caseine, gelatin) at breakfast meal at 1.8 and 3.6MJ/meal had no impact on 24 hour energy or macronutrient intakes (Lang et al., 1999, Eur J Clin Nutr, 959-65).
- Comparison of mycoprotein and tofu to a chicken preload before lunch indicated that the vegetarian sources were associated with lower food intake at lunch (Williamson et al., 2006, Appetite, 41-8).
- Addition of 25g protein in a liquid format (whey and soy) led to suppression of food intake (pizza meal) 1 hour later, in comparison to water and whey preload.
It is noted that all of these studies, (i) were conducted over a short time period (within day), (ii) none were high-protein weight loss diets (low calorie, high protein), (iii) none compared mixed meat versus vegetable source. It is of interest from both a scientific and public health point of view whether meat and vegetarian sources of protein similarly impact on motivation to eat.
The diets for this study:
- The maintenance diet (MTD) (day 1 - 3) will consist of 15% protein, 30% fat and 55% carbohydrate fed to 1.5 x RMR (resting metabolic rate)
- The high protein (HP) weight loss diet will be fed to 100% resting metabolic rate (RMR) on a 5 day rotation menu, fed as three meals a day, 30% protein, 30% fat and 40% carbohydrate; the meat version will be based on chicken and beef meat; the soya version based on soya protein or soya-tvp (textured vegetable protein).
Soya protein is now widely available as milk (ALPRO), margarine (PURE), enhanced bread (BURGEN), sausages (GRANOSE), bacon (GRANOSE), burgers (GRANOSE), mince (GRANOSE), powered isolate, cheese, cream (SOYA DREAM), yoghurt (ALPRO), chicken-style fillets (GRASSINGTONS).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein-Weight loss-Meat/High Protein-Weight loss Soy | Other | Other: High Protein-Weight loss-Soy diet, Other: High Protein-Weight loss-MeatAfter 3 Days - Normal Protein Maintenance diet (NP- MTD, 3 days), there is the first arm of the study, Days 14 days- randomised to High Protein-Weight loss-Meat with High Protein-Weight loss-Soy |
| High Protein-Weight loss-Soya/High Protein Weight loss-meat | Other | Other: High Protein-Weight loss-Soy diet, Other: High Protein-Weight loss-MeatAfter 3 Days - Normal Protein Maintenance diet (NP- MTD, 3 days), there is the first arm of the study, Days 14 days- randomised to High Protein-Weight loss-Soy with High Protein-Weight loss-Meat |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- Overweight or obese (BMI 27+ )
- With no existing medical conditions or medication that could influence appetite or mood.
Key exclusion criteria (11 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 |
|---|---|---|
| High Protein-Weight loss-Soy dietAlso: SOY HP WL diet• The high protein (HP) weight loss diet will be fed to 100% resting metabolic rate (RMR) on a 5 day rotation menu, fed as three meals a day, 30% protein, 30% fat and 40% carbohydrate; the soya version based on soya protein or soya-tvp (textured vegetable protein). | Other | High Protein-Weight loss-Meat/High Protein-Weight loss Soy, High Protein-Weight loss-Soya/High Protein Weight loss-meat |
| High Protein-Weight loss-MeatAlso: MEAT HP WL diet• The high protein (HP) weight loss diet will be fed to 100% resting metabolic rate (RMR) on a 5 day rotation menu, fed as three meals a day, 30% protein, 30% fat and 40% carbohydrate; the meat version will be based on chicken and beef meat. | Other | High Protein-Weight loss-Meat/High Protein-Weight loss Soy, High Protein-Weight loss-Soya/High Protein Weight loss-meat |
Primary outcome
appetite control
Time frame: Every day of the study: From day 1 to 32 inclusive
* Motivation to eat (VAS) hourly during waking hours up to 6pm in the evening, collected on a hand-help computer * Food diary * End of day questionnaire on mood
1 secondary outcome
Satiety biomarkers- COMPOSITE MEASURE
Time frame: test day (day 1, 4, 18, 32 of the study)
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 6 Mar 2014.
- Derived from this study: PubMed 24944057Neacsu M, Fyfe C, Horgan G, Johnstone AM. Appetite control and biomarkers of satiety with vegetarian (soy) and meat-based high-protein diets for weight loss in obese men: a randomized crossover trial. Am J Clin Nutr. 2014 Aug;100(2):548-58. doi: 10.3945/ajcn.113.077503. Epub 2014 Jun 18.
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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 M Johnstone, PhD principal investigator
Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, Scotland, UK,
Wendy R Russell, PhD principal investigator
Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, Scotland, UK,
Silvia Gratz, PhD principal investigator
Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, Scotland, UK,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein-Weight loss-Soy diet and High Protein-Weight loss-Meat in people with Obesity, 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 3 inclusion and 11 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 6 Mar 2014. 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. 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?
appetite control (time frame: Every day of the study: From day 1 to 32 inclusive). 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 NCT02080325, which also lists 1 linked publication.
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 6 Mar 2014.