Advanced Protein-based Program for Effective Treatment of Appetite Regulation and Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2024-10-31

Brief Summary

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INTRODUCTION: Obesity is a global epidemic, with over 2.5 billion adults being classified as overweight and 890 million of these classified as obese. Overweight and obesity are the 5th cause of mortality globally, with an estimated 2.8 million related deaths among adults. The rising prevalence of obesity in adults is leading to a rise in the prevalence of type 2 diabetes, with an estimated 462 million individuals affected globally. At present, the most effective non-surgical obesity treatments offered by the National Health Service (NHS) are the subcutaneously administered GLP-1 receptor agonists. However, they may present potentially serious side effects following short-term use, and there are still uncertainties around long-term use side effects. Therefore, a dietary approach to weight loss or maintenance seems preferable.

Increasing protein intake is a commonly applied nutritional approach to appetite regulation. The increase in protein intake is often achieved by supplementation, using proteins isolated from dairy, such as whey and casein. However, with more individuals following plant-based diets over recent years, the interest in plant-based protein supplements has increased. While dairy-based proteins are well-characterised, the appetite regulatory characteristics of plant-based proteins have not yet been fully elucidated.

The main aim of this study is to investigate the effects of protein-enriched food items on appetite regulation compared to a standard carbohydrate-rich meal. Furthermore, this study will investigate whether there are any differences in appetite-related hormonal responses to a plant protein-containing meal replacement shake (containing rice and pea protein) or a potato protein-enriched standard carbohydrate-based meal compared to a whey protein-enriched standard carbohydrate-based meal.

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Detailed Description

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Intervention study with four treatment groups in a randomised, single-blind, quadruple crossover design.

Healthy male participants (between the ages of 18 to 50 years) will receive four different isocaloric intervention meals with the same mass, on separate visit days, following a minimum of 8 hours overnight fast. The four meals will contain oat porridge prepared with coconut milk as a control, oat porridge prepared with coconut milk with added whey or potato protein isolates, and a complete meal replacement shake containing plant-based pea and rice proteins. The intervention meals will be followed by a standardised pasta-based ready meal after the 3-hour observation period. All participants will observe at least a two-day washout period between the differing treatments.

Biological samples (blood) will be collected at various times during the visit. Blood samples will be collected at baseline 0 min prior (T0), then at 30 min (T30), 60 min (T60), 120 min (T120) and 180 min (T180) after the intervention meal consumption.

In addition, pertinent questionnaires, Visual Analogue Scale \[VAS\] for assessing satiety and VAS for assessing intervention meals' perception and palatability will be collected. VAS for the assessment of satiety will be collected at T0, T30, T60, T120 and T180 and VAS assessing the perception and palatability of the intervention meals will be collected immediately following meal consumption.

Conditions

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Appetite and General Nutritional Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment, single-blind, randomised, quadruple crossover

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Single

Study Groups

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Oat porridge

Control Meal (9.5 g total protein)

Group Type SHAM_COMPARATOR

Oat porridge

Intervention Type OTHER

Oat flakes, 81g (equivalent to 9 g of protein), were presented to participants in the form of porridge, prepared with 500 mL coconut milk (equivalent to 0.5 g of protein) and 10 g of zero calorie sugar free syrup.

The total energy content was equivalent to 400 Kcal.

Participants were instructed to consume the entire meal presented to them in 15 minutes on an empty stomach when attending the study.

Oat porridge with whey protein

(total protein 40.5 g; of which whey protein isolate contributed 34.2 g of protein)

Group Type ACTIVE_COMPARATOR

Whey protein isolate

Intervention Type DIETARY_SUPPLEMENT

Whey protein isolate, 38g (equivalent to 34.2 g of protein), was presented to participants in the form of a porridge.

Other ingredients in the whey protein enriched porridge:

* Oat flakes 54 g (equivalent to 6 g of protein)
* Coconut milk 300 mL (equivalent to 0.3 g of protein)
* Water 150 mL
* Zero calorie sugar free syrup 10 g

The total energy content was equivalent to 401.74 Kcal.

Participants were instructed to consume the entire meal presented to them in 15 minutes on an empty stomach when attending the study

Oat porridge with potato protein

(total protein 40.6 g; of which potato protein isolate contributed 34.39 g of protein)

Group Type ACTIVE_COMPARATOR

Potato protein isolate

Intervention Type DIETARY_SUPPLEMENT

Potato protein isolate, 38g (equivalent to 34.39 g of protein), was presented to participants in the form of a porridge.

Other ingredients in the potato protein enriched porridge:

* Oat flakes 54 g (equivalent to 6 g of protein)
* Coconut milk 300 mL (equivalent to 0.3 g of protein)
* Water 150 mL
* Zero calorie sugar free syrup 10 g

The total energy content equiv. 401.36 Kcal.

Participants were instructed to consume the entire meal presented to them in 15 minutes on an empty stomach when attending the study.

Meal replacement shake

(total protein 40 g, mostly from pea protein and brown rice protein isolates)

Group Type ACTIVE_COMPARATOR

Meal replacement shake

Intervention Type DIETARY_SUPPLEMENT

A meal replacement, 90 g (equivalent to 40 g of total protein), was presented to participants in the form of a shake.

Other ingredients in the meal replacement shake:

\- Water 500 mL

The total energy was equivalent to 400 Kcal

Participants were instructed to consume the entire meal replacement shake presented to them in 15 minutes on an empty stomach when attending the study.

Interventions

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Oat porridge

Oat flakes, 81g (equivalent to 9 g of protein), were presented to participants in the form of porridge, prepared with 500 mL coconut milk (equivalent to 0.5 g of protein) and 10 g of zero calorie sugar free syrup.

The total energy content was equivalent to 400 Kcal.

Participants were instructed to consume the entire meal presented to them in 15 minutes on an empty stomach when attending the study.

Intervention Type OTHER

Whey protein isolate

Whey protein isolate, 38g (equivalent to 34.2 g of protein), was presented to participants in the form of a porridge.

Other ingredients in the whey protein enriched porridge:

* Oat flakes 54 g (equivalent to 6 g of protein)
* Coconut milk 300 mL (equivalent to 0.3 g of protein)
* Water 150 mL
* Zero calorie sugar free syrup 10 g

The total energy content was equivalent to 401.74 Kcal.

Participants were instructed to consume the entire meal presented to them in 15 minutes on an empty stomach when attending the study

Intervention Type DIETARY_SUPPLEMENT

Potato protein isolate

Potato protein isolate, 38g (equivalent to 34.39 g of protein), was presented to participants in the form of a porridge.

Other ingredients in the potato protein enriched porridge:

* Oat flakes 54 g (equivalent to 6 g of protein)
* Coconut milk 300 mL (equivalent to 0.3 g of protein)
* Water 150 mL
* Zero calorie sugar free syrup 10 g

The total energy content equiv. 401.36 Kcal.

Participants were instructed to consume the entire meal presented to them in 15 minutes on an empty stomach when attending the study.

Intervention Type DIETARY_SUPPLEMENT

Meal replacement shake

A meal replacement, 90 g (equivalent to 40 g of total protein), was presented to participants in the form of a shake.

Other ingredients in the meal replacement shake:

\- Water 500 mL

The total energy was equivalent to 400 Kcal

Participants were instructed to consume the entire meal replacement shake presented to them in 15 minutes on an empty stomach when attending the study.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Males (18-50 years of age)
* Lean and Overweight subjects (BMI 18.5 - 30 kg/m2)
* Sedentary and physically active subjects
* Healthy subjects

Exclusion Criteria

* Female
* \<18, \>50 years
* Dieting
* Consumption of \>14 units of alcohol/week
* Allergies to test foods/drinks
* Illnesses or on medication (with a possible effect on taste and/or appetite)
* Devices such as pacemakers
* Smokers
* Gastrointestinal disorders
* Eating disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes