Weight LossNCT02418429
Resistant Starch and Whey Protein on Energy Metabolism
A study testing waxy maize starch, waxy maize starch and Whey Protein and Resistant Starch in people with Weight Loss, run by Skidmore College.
Trial summary
Recent evidence shows that dietary supplementation with resistant starch (RS) increases fat catabolism and resting energy expenditure and decreases plasma insulin and glucose responses as well as the gut-derived hormone, glucose-dependent insulinotropic polypeptide (GIP). Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- waxy maize starch, waxy maize starch and Whey Protein and Resistant Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2018
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight or lean but otherwise healthy
Who cannot join
- Participants will be excluded if they smoke; have experienced excessive weight loss/gain of > ±2kg in the previous 2 months; are currently taking medications for cardiovascular or metabolic disease.
About this study
Official title: Combined Effects of Dietary Supplementation With Dietary Resistant Starch (RS) and Whey Protein on Resting Energy Expenditure and Blood Sugar and Insulin Responses in Lean and Obese Men and Women
Recent evidence shows that dietary supplementation with resistant starch (RS) increases fat catabolism and resting energy expenditure and decreases plasma insulin and glucose responses as well as the gut-derived hormone, glucose-dependent insulinotropic polypeptide (GIP). Consumption of whey protein has also been shown to increase energy expenditure and favorably affect gut hormones. Thus, investigators tested consumption of both RS and whey protein on energy expenditure and gut hormones in lean and obese women and men.
Read the detailed description
Consumed separately, resistant starch (RS) and whey protein (WP) favorably affect energy metabolism and gut hormones, as well as suppress feelings of hunger. These findings are important because release of certain gut hormones (i.e., GIP) is associated with a lower resting energy expenditure (REE) in healthy humans. Interestingly, a recent study showed that ingestion of RS reduces postprandial GIP and increases postprandial REE and fat utilization in healthy men and therefore may be an effective strategy in weight management. Thus, there is a need to replicate these findings in a healthy cohort of lean and obese women and men.
The purpose of this study was to examine the effects of RS on the number of calories burned after eating a meal, as well as specific hormones that are released from the stomach and intestines following meal ingestion in healthy lean and obese women and men. Investigators used a single ingestion of a meal supplemented with or without the resistant starch and whey protein.
- Conditions
- Weight Loss
- Being tested
- waxy maize starch, waxy maize starch and Whey Protein, Resistant Starch, resistant starch and whey protein
- Keywords
- fat oxidation, hunger, resistant starch, whey protein
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waxy maize starchOther
Also called WMS
pancake test meal with waxy maize starch only
waxy maize starch and Whey ProteinOther
Also called WMS-WP
pancake test meal with waxy maize starch and whey protein
Resistant StarchOther
Also called RS
pancake test meal with resistant starch only
resistant starch and whey proteinOther
Also called RS-WP
pancake test meal with resistant starch and whey protein
| Study group | Role | What they receive |
|---|---|---|
| waxy maize starch | Active comparator | pancake test meal - waxy maize starch Receives: Other: waxy maize starch |
| waxy maize starch and whey protein | Active comparator | pancake test meal - waxy maize starch and whey protein Receives: Other: waxy maize starch; Other: waxy maize starch and Whey Protein |
| resistant starch | Active comparator | pancake test meal - resistant starch Receives: Other: Resistant Starch |
| resistant starch and whey protein | Active comparator | pancake test meal - resistant starch and whey protein Receives: Other: Resistant Starch; Other: resistant starch and whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat oxidation from Baseline to 180 Minutes Postprandial
indirect calorimetry of fuel utilization
Measured: time 0, 60, 120, 180 minutes
Secondary outcomes (2)
Change in gut hormones from Baseline to 180 Minutes Postprandial
gastro-entero-pancreatic hormones
Measured: time 0, 60, 120, 180 minutes
Change in self-reported feelings of hunger, fullness, satiation from Baseline to 180 Minutes Postprandial
visual analog scale of hunger, fullness and satiation
Measured: time 0, 60, 120, 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionAug 2018
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 Weight LossStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skidmore College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul J Arciero, PhD, Principal investigator, Skidmore College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418429
- Sponsor's protocol ID
- 1307-348
- Status last verified
- Sep 2018
- First submitted
- 7 Apr 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gentile CL, Ward E, Holst JJ, Astrup A, Ormsbee MJ, Connelly S, Arciero PJ. Resistant starch and protein intake enhances fat oxidation and feelings of fullness in lean and overweight/obese women. Nutr J. 2015 Oct 29;14:113. doi: 10.1186/s12937-015-0104-2.
PubMed 26514213
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Dietary Supplementation With Dietary Resistant Starch (RS) and Whey Protein on Resting Energy Expenditure and Blood Sugar and Insulin Responses in Lean and Obese Men and Women
- ClinicalTrials.gov ID
- NCT02418429
- Acronym / sponsor ID
- 1307-348
- Conditions
- Weight Loss
- Keywords
- fat oxidation, hunger, resistant starch, whey protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Skidmore CollegeUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 16 Apr 2015 (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.
Recent evidence shows that dietary supplementation with resistant starch (RS) increases fat catabolism and resting energy expenditure and decreases plasma insulin and glucose responses as well as the gut-derived hormone, glucose-dependent insulinotropic polypeptide (GIP). Consumption of whey protein has also been shown to increase energy expenditure and favorably affect gut hormones. Thus, investigators tested consumption of both RS and whey protein on energy expenditure and gut hormones in lean and obese women and men.
Detailed description
Consumed separately, resistant starch (RS) and whey protein (WP) favorably affect energy metabolism and gut hormones, as well as suppress feelings of hunger. These findings are important because release of certain gut hormones (i.e., GIP) is associated with a lower resting energy expenditure (REE) in healthy humans. Interestingly, a recent study showed that ingestion of RS reduces postprandial GIP and increases postprandial REE and fat utilization in healthy men and therefore may be an effective strategy in weight management. Thus, there is a need to replicate these findings in a healthy cohort of lean and obese women and men.
The purpose of this study was to examine the effects of RS on the number of calories burned after eating a meal, as well as specific hormones that are released from the stomach and intestines following meal ingestion in healthy lean and obese women and men. Investigators used a single ingestion of a meal supplemented with or without the resistant starch and whey protein.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| waxy maize starch | Active comparator | Other: waxy maize starchpancake test meal - waxy maize starch |
| waxy maize starch and whey protein | Active comparator | Other: waxy maize starch, Other: waxy maize starch and Whey Proteinpancake test meal - waxy maize starch and whey protein |
| resistant starch | Active comparator | Other: Resistant Starchpancake test meal - resistant starch |
| resistant starch and whey protein | Active comparator | Other: Resistant Starch, Other: resistant starch and whey proteinpancake test meal - resistant starch and whey protein |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- overweight or lean but otherwise healthy
Key exclusion criteria (1 listed)
- Participants will be excluded if they smoke; have experienced excessive weight loss/gain of > ±2kg in the previous 2 months; are currently taking medications for cardiovascular or metabolic disease.
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 |
|---|---|---|
| waxy maize starchAlso: WMSpancake test meal with waxy maize starch only | Other | waxy maize starch, waxy maize starch and whey protein |
| waxy maize starch and Whey ProteinAlso: WMS-WPpancake test meal with waxy maize starch and whey protein | Other | waxy maize starch and whey protein |
| Resistant StarchAlso: RSpancake test meal with resistant starch only | Other | resistant starch, resistant starch and whey protein |
| resistant starch and whey proteinAlso: RS-WPpancake test meal with resistant starch and whey protein | Other | resistant starch and whey protein |
Primary outcome
Change in fat oxidation from Baseline to 180 Minutes Postprandial
Time frame: time 0, 60, 120, 180 minutes
indirect calorimetry of fuel utilization
2 secondary outcomes
Change in gut hormones from Baseline to 180 Minutes Postprandial
Time frame: time 0, 60, 120, 180 minutes
Change in self-reported feelings of hunger, fullness, satiation from Baseline to 180 Minutes Postprandial
Time frame: time 0, 60, 120, 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 6 Sep 2018.
- Derived from this study: PubMed 26514213Gentile CL, Ward E, Holst JJ, Astrup A, Ormsbee MJ, Connelly S, Arciero PJ. Resistant starch and protein intake enhances fat oxidation and feelings of fullness in lean and overweight/obese women. Nutr J. 2015 Oct 29;14:113. doi: 10.1186/s12937-015-0104-2.
- Individual participant dataSharing planned: Undecided
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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.
Paul J Arciero, PhD principal investigator
Skidmore College
Questions about this trial
What is this clinical trial studying?
A study testing waxy maize starch, waxy maize starch and Whey Protein and Resistant Starch in people with Weight Loss, run by Skidmore College.
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 1 inclusion and 1 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 fat oxidation from Baseline to 180 Minutes Postprandial (time frame: time 0, 60, 120, 180 minutes). 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 NCT02418429, 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 6 Sep 2018.