Pre-diabetesNCT02933424
Project Plant Protein: the P3 Study in Humans
A study testing Protein Powder in people with Pre-diabetes and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The objective of this study is to compare the effects of adding three plant-based proteins (rice, oats and pea proteins) to a breakfast beverage on the glycemic response, appetite and subsequent food intake of healthy adults. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Obesity
- What is being tested?
- Protein Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2016to 26 Oct 2017
- 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 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males
- BMI 18.5-24.9kgm-2
- eating all meals (5 days/week)
Who cannot join
- major chronic disease such as heart disease, cancer, hypertension or diabetes mellitus
- have gout
- have food allergies
- are taking insulin or drugs known to affect metabolism, appetite and body fat distribution,
- have weight change of >5kg in the past 3 months
- have major medical or surgical event requiring hospitalisation within the preceding three months
Show all 9Show fewer
- are on a weight loss regime, and presence of disease or drugs which influence digestion and absorption of nutrients
- smokers,
- individuals who take part in sports at competitive/endurance levels
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Plant Proteins on Blood Glucose & Amino Acid Levels and Satiety in Humans
The objective of this study is to compare the effects of adding three plant-based proteins (rice, oats and pea proteins) to a breakfast beverage on the glycemic response, appetite and subsequent food intake of healthy adults.
Read the detailed description
A diet or a meal higher in dietary protein has been reported to promote satiety and suppress food intake in humans in several previous studies. It was suggested that the presence of amino acid in the blood as a result of higher protein intake served as signals that suppress appetite in humans. More recently, it has been observed that incomplete or lower quality proteins, i.e. those missing one or more essential amino acids, may suppress hunger more than complete proteins, as the ingestion of incomplete proteins in the long term may lead to deficiency of essential amino acids. Plant proteins are generally considered incomplete protein when compared to animal proteins, which mean that plant protein may have higher appetite-suppressing effects.
Dietary carbohydrates are the most potent stimuli of insulin secretion. However, the addition of dietary protein in a carbohydrate-rich meal has been shown to further stimulate insulin release.The insulinotropic effect of dietary protein is thought to be attributed to the branched-chain amino acid (BCAA) content of the protein-rich meal. Interestingly, there is a hierarchy of effects induced by protein from different sources. For example, milk protein has been shown to be superior to fish or plant protein in stimulating insulin secretion following a meal.Even within milk protein, whey protein stimulated insulin secretion more than casein protein. One of the factors that distinguish whey from casein proteins was the digestibility or the digestion rate of these proteins. Protein that is digested faster appear to increase blood amino acid levels faster, and increase insulin release faster.This implies that plant proteins that have lower digestibility rate relative to animal proteins may have lower insulinotropic effects, and the effective dose required to achieve optimal insulin secretion may be different from animal protein and warrants further investigation. In addition, the amino acid profile (in addition to lower digestibility) of plant proteins may differ from animal protein, especially the BCAA content that is associated with the stimulation of insulin secretion.
Dietary patterns and cuisines vary between countries and cultures. Unlike in the Western countries, plant-based foods are more commonly consumed in an Asian cuisine. Based on the statistics released by Food and Agriculture Organization, cereals and meat are the top two protein sources in both Western (29.1% and 26.4% respectively) and Asian (58.8% and 8.6% respectively) countries. The third major source of protein is dairy (16.7%) in Western countries, and pulses in Asia (7.4%). In addition, vegetarianism is widely practiced in Asian countries. Studies investigating the appetitive and the blood glucose regulating effects of dietary protein have been focused predominantly in animal protein, with a number of studies included plant-based protein such as soy protein. Since cereals and pulses are an important part of an Asian cuisine, it is important to understand and compare the effects of proteins from these sources on blood glucose and appetite regulation. Since the amino acid profile and the digestibility of these plant-based proteins differ from animal protein, it is important to also understand the effective dose that exerts optimal effects.
- Conditions
- Pre-diabetes, Obesity
- Being tested
- Protein Powder
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein PowderDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Control beverage with no protein powder | No intervention | Standard breakfast drink with no protein powder added |
| Beverage with Rice protein powder 25 grams | Experimental | Standard breakfast drink with 25 grams of rice protein powder. Receives: Dietary Supplement: Protein Powder |
| Beverage with Pea protein powder 25 grams | Experimental | Standard breakfast drink with 25 grams of pea protein powder. Receives: Dietary Supplement: Protein Powder |
| Beverage with Oats protein powder 25 grams | Experimental | Standard breakfast drink with 25 grams of Oats protein powder. Receives: Dietary Supplement: Protein Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose
Blood glucose measured up to 180 minutes
Measured: Up to 180 minutes
Change in blood insulin
Blood insulin measured up to 180 minutes
Measured: Up to 180 minutes
Change in gut hormones
Blood gut hormones measured up to 180 minutes
Measured: Up to 180 minutes
Change in body weight
Body weight measured with a Bio-electrical impedance scale
Measured: At baseline
Change in body composition
Fat% measured with a Bio-electrical impedance scale
Measured: At baseline
Secondary outcomes (3)
Change in subjective appetite ratings
Appetite ratings measured up to 180 minutes
Measured: Up to 180 minutes
Change in plasma amino acid
Blood amino acid profile measured up to 180 minutes
Measured: Up to 180 minutes
Meal challenge
Ad libitum meal challenge at 180-minutes
Measured: At 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
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 Pre-diabetesStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933424
- Sponsor's protocol ID
- 2016/00796
- Other IDs
- 2016
- Status last verified
- Jan 2018
- First submitted
- 27 Sep 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Tan SY, Siow PC, Peh E, Henry CJ. Influence of rice, pea and oat proteins in attenuating glycemic response of sugar-sweetened beverages. Eur J Nutr. 2018 Dec;57(8):2795-2803. doi: 10.1007/s00394-017-1547-3. Epub 2017 Sep 30.
PubMed 28965176
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Plant Proteins on Blood Glucose & Amino Acid Levels and Satiety in Humans
- ClinicalTrials.gov ID
- NCT02933424
- Acronym / sponsor ID
- 2016/00796
- Conditions
- Pre-diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Sep 2016
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 14 Oct 2016 (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.
The objective of this study is to compare the effects of adding three plant-based proteins (rice, oats and pea proteins) to a breakfast beverage on the glycemic response, appetite and subsequent food intake of healthy adults.
Detailed description
A diet or a meal higher in dietary protein has been reported to promote satiety and suppress food intake in humans in several previous studies. It was suggested that the presence of amino acid in the blood as a result of higher protein intake served as signals that suppress appetite in humans. More recently, it has been observed that incomplete or lower quality proteins, i.e. those missing one or more essential amino acids, may suppress hunger more than complete proteins, as the ingestion of incomplete proteins in the long term may lead to deficiency of essential amino acids. Plant proteins are generally considered incomplete protein when compared to animal proteins, which mean that plant protein may have higher appetite-suppressing effects.
Dietary carbohydrates are the most potent stimuli of insulin secretion. However, the addition of dietary protein in a carbohydrate-rich meal has been shown to further stimulate insulin release.The insulinotropic effect of dietary protein is thought to be attributed to the branched-chain amino acid (BCAA) content of the protein-rich meal. Interestingly, there is a hierarchy of effects induced by protein from different sources. For example, milk protein has been shown to be superior to fish or plant protein in stimulating insulin secretion following a meal.Even within milk protein, whey protein stimulated insulin secretion more than casein protein. One of the factors that distinguish whey from casein proteins was the digestibility or the digestion rate of these proteins. Protein that is digested faster appear to increase blood amino acid levels faster, and increase insulin release faster.This implies that plant proteins that have lower digestibility rate relative to animal proteins may have lower insulinotropic effects, and the effective dose required to achieve optimal insulin secretion may be different from animal protein and warrants further investigation. In addition, the amino acid profile (in addition to lower digestibility) of plant proteins may differ from animal protein, especially the BCAA content that is associated with the stimulation of insulin secretion.
Dietary patterns and cuisines vary between countries and cultures. Unlike in the Western countries, plant-based foods are more commonly consumed in an Asian cuisine. Based on the statistics released by Food and Agriculture Organization, cereals and meat are the top two protein sources in both Western (29.1% and 26.4% respectively) and Asian (58.8% and 8.6% respectively) countries. The third major source of protein is dairy (16.7%) in Western countries, and pulses in Asia (7.4%). In addition, vegetarianism is widely practiced in Asian countries. Studies investigating the appetitive and the blood glucose regulating effects of dietary protein have been focused predominantly in animal protein, with a number of studies included plant-based protein such as soy protein. Since cereals and pulses are an important part of an Asian cuisine, it is important to understand and compare the effects of proteins from these sources on blood glucose and appetite regulation. Since the amino acid profile and the digestibility of these plant-based proteins differ from animal protein, it is important to also understand the effective dose that exerts optimal effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control beverage with no protein powder | No intervention | –Standard breakfast drink with no protein powder added |
| Beverage with Rice protein powder 25 grams | Experimental | Dietary Supplement: Protein PowderStandard breakfast drink with 25 grams of rice protein powder. |
| Beverage with Pea protein powder 25 grams | Experimental | Dietary Supplement: Protein PowderStandard breakfast drink with 25 grams of pea protein powder. |
| Beverage with Oats protein powder 25 grams | Experimental | Dietary Supplement: Protein PowderStandard breakfast drink with 25 grams of Oats protein powder. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males
- BMI 18.5-24.9kgm-2
- eating all meals (5 days/week)
Key exclusion criteria (9 listed)
- major chronic disease such as heart disease, cancer, hypertension or diabetes mellitus
- have gout
- have food allergies
- are taking insulin or drugs known to affect metabolism, appetite and body fat distribution,
- have weight change of >5kg in the past 3 months
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 |
|---|---|---|
| Protein Powder | Dietary supplement | Beverage with Oats protein powder 25 grams, Beverage with Pea protein powder 25 grams, Beverage with Rice protein powder 25 grams |
Primary outcome
Change in blood glucose
Time frame: Up to 180 minutes
Blood glucose measured up to 180 minutes
Change in blood insulin
Time frame: Up to 180 minutes
Blood insulin measured up to 180 minutes
Change in gut hormones
Time frame: Up to 180 minutes
Blood gut hormones measured up to 180 minutes
Change in body weight
Time frame: At baseline
Body weight measured with a Bio-electrical impedance scale
Change in body composition
Time frame: At baseline
Fat% measured with a Bio-electrical impedance scale
3 secondary outcomes
Change in subjective appetite ratings
Time frame: Up to 180 minutes
Change in plasma amino acid
Time frame: Up to 180 minutes
Meal challenge
Time frame: At 180 minutes
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 25 Jan 2018.
- Derived from this study: PubMed 28965176Tan SY, Siow PC, Peh E, Henry CJ. Influence of rice, pea and oat proteins in attenuating glycemic response of sugar-sweetened beverages. Eur J Nutr. 2018 Dec;57(8):2795-2803. doi: 10.1007/s00394-017-1547-3. Epub 2017 Sep 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Powder in people with Pre-diabetes and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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 9 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 25 Jan 2018. 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 Singapore. 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?
Change in blood glucose (time frame: Up to 180 minutes). The study lists 5 primary outcomes in all. 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 NCT02933424, 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 25 Jan 2018.