Ignite Creation Date:
2024-05-06 @ 2:37 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02080325
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2014-02-28
Brief Title:
Vegetarian High Protein Weight Loss Diets
Sponsor:
University of Aberdeen
Organization:
University of Aberdeen
Study Overview
Official Title:
Vegetarian High Protein Weight Loss Diets
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALPROsoya
Brief Summary:
This study aims to investigate the mechanistic processes involved in protein-induced satietysatiation 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-Soya14 days
2 nd ARM Days 18-31 - randomised to High Protein-Weight loss-Soya HP-meat14 days
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-Soya14 days
2 nd ARM Days 18-31 - randomised to High Protein-Weight loss-Soya HP-meat14 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 al1998 Am J Clin Nutr 1197-204
Varying protein source soy caseine gelatin at breakfast meal at 18 and 36MJmeal 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 15 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
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 al1998 Am J Clin Nutr 1197-204
Varying protein source soy caseine gelatin at breakfast meal at 18 and 36MJmeal 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 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ALPRO Foundation | OTHER_GRANT | The Scottish Governments Rural and Environment Science and Analytical Services Division | None |