Type 2 Diabetes MellitusNCT01413126

Peanuts Second Meal Glycemic Response

A study of Type 2 Diabetes Mellitus, run by Federal University of Vicosa at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Type 2 Diabetes Mellitus
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteBrazil
Study dates: Oct 2009to Feb 2011
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 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Body mass index between 30 - 35 kg/M2
Not taking medications known to affect glycemia, fat metabolism, or appetite
Regular breakfast consumer (≥100 kilocalories ingested within 2 hours of waking on ≥4d/wk)
No body weight fluctuation (<5kg in the past 3 months)
Willingness to eat all test foods
No self-reported allergy to the foods provided in the study
No self-reported sleep disorders
At least one of the following conditions: waist circumference ≥ 88 cm; reported family history of Type 2 diabetes in first degree relatives; capillary glycemia between 5.5 - 7.0 mmol/L; and/or a 2-hour blood glucose of 7.8 - 11.1 mmol/L (impaired glucose tolerance)

Who cannot join

Type 2 diabetes mellitus
Dyslipidemia
High blood pressure

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of Viçosa
Viçosa, Minas Gerais, 36570-000

Other trials in Brazil

About this study

Official title: Acute and Second Meal Effects of Peanuts on Glycemic Response and Appetite in Obese Women With High Type 2 Diabetes Risk: a Randomized Crossover Trial

Nut consumption is associated with reduced risk of Type 2 diabetes. The aim of this study was to assess the effects of peanut (whole or peanut butter) to breakfast meals on glycemic, insulinemic and selected gut hormone responses, appetite, and food intake over two consecutive meals in obese women with high Type 2 diabetes risk. Fifteen women participated in a randomized crossover trial where 42.5g of whole peanuts (P), peanut butter (PB), or no peanuts (control-C) were added to a 75g available carbohydrate-matched breakfast meal. Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids (NEFA), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), appetitive sensations and food intake were assessed after breakfast treatments and a standard lunch (75g available carbohydrate).

Conditions: Type 2 Diabetes Mellitus
Being tested: Whole peanuts without skins, Peanut butter, or no peanuts (control)
Keywords: Peanut, Blood glucose, Insulin, Non-esterified free fatty acids, Glucagon-like peptide-1, Peptide YY, Cholecystokinin, Appetitive, Food intake
Medical subject headings: Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Whole peanuts without skins, Peanut butter, or no peanuts (control)Dietary supplement
In accordance with the Food and Drug Administration qualified health claim regarding daily nut intake, 42.5 g of whole peanuts or peanut butter were added to a 75g available carbohydrate-matched breakfast meal each test session.

Study groups in NCT01413126
Study group	Role	What they receive
Peanut butter	Experimental	42.5 g of Peanuts butter were added to a 75g available carbohydrate-matched breakfast meal Receives: Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)
Whole peanut	Experimental	42.5 g of whole peanuts were added to a 75g available carbohydrate-matched breakfast meal Receives: Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)
No peanuts (control)	No intervention	Not described Receives: Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in glucose homeostasis at eight hours
Postprandial concentrations and incremental area under the curve of blood glucose, insulin and glucagon-like peptide-1, and incremental area above the curve of non-esterified free fatty acids were assessed after breakfast treatments and a standard lunch
Measured: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430 and 490 minutes

Secondary outcomes (3)

Change from baseline in incretin hormones at four hours
Postprandial concentrations and the incremental area under the curve of peptide YY and cholecystokinin were assessed after breakfast treatments
Measured: Baseline (-10), 15, 45, 60, 90, 120, 180 and 240 minutes
Change in food intake over 24 hours
All food consumed in laboratory and after leaving the laboratory in the experiment day were recorded
Measured: 24 hours
Change from baseline in appetitive sensations at twelve hours
Appetite ratings were scored at baseline and in a pre-determined times on a 100 mm visual analogue scale anchored with descriptors of "not at all" and "extremely"
Measured: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430, 490, 550, 610, 670 and 730 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Feb 2011

First posted10 Aug 2011 (estimated)
Study startOct 2009
Primary completionSep 2010
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01413126
Sponsor's protocol ID: NUTBRA
Status last verified: Aug 2011
First submitted: 8 Aug 2011
Last updated: 10 Aug 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute and Second Meal Effects of Peanuts on Glycemic Response and Appetite in Obese Women With High Type 2 Diabetes Risk: a Randomized Crossover Trial
ClinicalTrials.gov ID: NCT01413126
Acronym / sponsor ID: NUTBRA
Conditions: Type 2 Diabetes Mellitus
Keywords: Peanut, Blood glucose, Insulin, Non-esterified free fatty acids, Glucagon-like peptide-1, Peptide YY, Cholecystokinin, Appetitive
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Federal University of VicosaUniversity, hospital or other
Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais, United States Agency for International Development (USAID)
Study start: Oct 2009
Primary completion: Sep 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 10 Aug 2011 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Peanut butter	Experimental	Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)42.5 g of Peanuts butter were added to a 75g available carbohydrate-matched breakfast meal
Whole peanut	Experimental	Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)42.5 g of whole peanuts were added to a 75g available carbohydrate-matched breakfast meal
No peanuts (control)	No intervention	Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Body mass index between 30 - 35 kg/M2
Not taking medications known to affect glycemia, fat metabolism, or appetite
Regular breakfast consumer (≥100 kilocalories ingested within 2 hours of waking on ≥4d/wk)
No body weight fluctuation (<5kg in the past 3 months)
Willingness to eat all test foods

Key exclusion criteria (3 listed)

Type 2 diabetes mellitus
Dyslipidemia
High blood pressure

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
Whole peanuts without skins, Peanut butter, or no peanuts (control)In accordance with the Food and Drug Administration qualified health claim regarding daily nut intake, 42.5 g of whole peanuts or peanut butter were added to a 75g available carbohydrate-matched breakfast meal each test session.	Dietary supplement	No peanuts (control), Peanut butter, Whole peanut

Primary outcome

Change from baseline in glucose homeostasis at eight hours
Time frame: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430 and 490 minutes
Postprandial concentrations and incremental area under the curve of blood glucose, insulin and glucagon-like peptide-1, and incremental area above the curve of non-esterified free fatty acids were assessed after breakfast treatments and a standard lunch

3 secondary outcomes

Change from baseline in incretin hormones at four hours
Time frame: Baseline (-10), 15, 45, 60, 90, 120, 180 and 240 minutes
Change in food intake over 24 hours
Time frame: 24 hours
Change from baseline in appetitive sensations at twelve hours
Time frame: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430, 490, 550, 610, 670 and 730 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 10 Aug 2011.

Related trials for Type 2 Diabetes Mellitus

Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
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The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
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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.

Caio EG Reis, PhD Student principal investigator

University of Brasília, Brazil

Daniela N Ribeiro, M.Sc. study chair

Federal University of Viçosa, Brazil

Neuza MB Costa, Ph.D. study chair

Federal University of Espírito Santo, Brazil

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Type 2 Diabetes Mellitus, run by Federal University of Vicosa at 1 site in Brazil.

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 8 inclusion and 3 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 10 Aug 2011. 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 Brazil. 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 from baseline in glucose homeostasis at eight hours (time frame: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430 and 490 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 NCT01413126.

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 10 Aug 2011.