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Vegetarian High Protein Weight Loss Diets (ALPROsoya)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02080325
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

Brief 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 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)

  1. st ARM Days 4-17 - randomised to High Protein-Weight loss-Meat (HP-Soya,14 days),
  2. nd ARM Days 18-31 - randomised to High Protein-Weight loss-Soya (HP-meat,14 days),

Condition or disease Intervention/treatment Phase
Obesity Other: High Protein-Weight loss-Soy diet Other: High Protein-Weight loss-Meat Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Vegetarian High Protein Weight Loss Diets
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
High Protein-Weight loss-Meat/High Protein-Weight loss Soy
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
Other: High Protein-Weight loss-Soy 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 Name: SOY HP WL diet

Other: High Protein-Weight loss-Meat
• 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 Name: MEAT HP WL diet

High Protein-Weight loss-Soya/High Protein Weight loss-meat
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
Other: High Protein-Weight loss-Soy 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 Name: SOY HP WL diet

Other: High Protein-Weight loss-Meat
• 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 Name: MEAT HP WL diet




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Satiety biomarkers- COMPOSITE MEASURE [ Time Frame: test day (day 1, 4, 18, 32 of the study) ]
    • 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


Other Outcome Measures:
  1. Weight loss [ Time Frame: Every day of the study from day 1 to 32 inclusive ]
    The subjects visited the Human Nutrition Unit at the Rowett Institute of Nutrition and Health (RINH), Aberdeen, United Kingdom daily for the weight measurement, after voiding, while wearing only a previously weighed dressing gown, to the nearest 100 g on a digital scale (DIGI DS-410; CMS Weighing Equipment, London, United Kingdom).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • Overweight or obese (BMI 27+ )
  • With no existing medical conditions or medication that could influence appetite or mood.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080325


Locations
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United Kingdom
Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, United Kingdom, AB21 9SB
Sponsors and Collaborators
University of Aberdeen
Investigators
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Principal Investigator: Alexandra M Johnstone, PhD Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, Scotland, UK,
Principal Investigator: Wendy R Russell, PhD Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, Scotland, UK,
Principal Investigator: Silvia Gratz, PhD Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, Scotland, UK,
Principal Investigator: Graham Horgan, PhD Biomathematics and Statistics Scotland, Aberdeen, Scotland, UK
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT02080325    
Other Study ID Numbers: 783 Soya
ALPRO™ Foundation ( Other Grant/Funding Number: The Scottish Government's Rural and Environment Science and Analytical Services Division )
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014
Keywords provided by University of Aberdeen:
weight loss
high protein diet
plant protein
satiety
soy
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight