Vegetarian High Protein Weight Loss Diets

NCT02080325 | Completed

• 2 other identifiers: 783 SoyaALPRO™ Foundation
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)
• 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),

Conditions

Obesity

Keywords

weight loss; high protein diet; plant protein; satiety; soy

Outcome Measures

Primary Outcomes (1)

• 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

  Every day of the study: From day 1 to 32 inclusive

Secondary Outcomes (1)

• Satiety biomarkers- COMPOSITE MEASURE

  test day (day 1, 4, 18, 32 of the study)

Other Outcomes (1)

• Weight loss

  Every day of the study from day 1 to 32 inclusive

Study Arms (2)

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

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

Other: High Protein-Weight loss-Soy diet; Other: High Protein-Weight loss-Meat

Interventions

High Protein-Weight loss-Soy diet OTHER

• 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).

Also known as: SOY HP WL diet

High Protein-Weight loss-Meat/High Protein-Weight loss Soy; High Protein-Weight loss-Soya/High Protein Weight loss-meat

High Protein-Weight loss-Meat OTHER

• 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.

Also known as: MEAT HP WL diet

High Protein-Weight loss-Meat/High Protein-Weight loss Soy; High Protein-Weight loss-Soya/High Protein Weight loss-meat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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)

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Rowett Institute of Nutrition and Health, University of Aberdeen

Aberdeen, AB21 9SB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24944057 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 6, 2014
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 6, 2014

Record last verified: 2014-03

Locations

GB (1)