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Type-2 DiabetesNCT01264523

Nutritional Intervention With Moderately High-protein, Low-glycemic Load Products in Type-2 Diabetes Patients

A study testing Chronologically scheduled snacking with 40-30-30 products in people with Type-2 Diabetes and Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

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

The main objective of this study is to evaluate the effects on anthropometric, glucose metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2 diabetes patients following a chronologically… Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Type-2 Diabetes, Overweight
What is being tested?
Chronologically scheduled snacking with 40-30-30 products
How many people
17 participants
Where
1 siteSpain
Study dates
Sep 2009to Sep 2010
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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinically diagnosed of type-2 Diabetes
  • Under dietary treatment or with Metformin
  • Body Mass Index (BMI) Between 22 and 35 kg/m2

Who cannot join

  • BMI under 22 or over 35 kg/m2
  • To follow a pharmacological treatment with other drugs but metformin
  • To be already insulin-dependent
  • To have other concomitant pharmacological treatments for weight loss, hormonal substitutive therapy, altered thyroid function, etc. without an stable dosage (at least three months prior the beginning of the study).
  • To suffer from complications due to type 2 diabetes (microangiopathy, polyneuropathy, cardiopathy, hepatic and renal impairments, etc)
  • To have a recent (less than 3 months before the beginning of the study) uncontrolled diagnostic of hypercholesterolemia and/or hypertriglyceridemia.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: Short-term Effect of the Intake of Moderately High-protein, Low-glycemic Load Products on Anthropometrical, Glucose Metabolism and Lipid Metabolism Biomarkers, in Type-2 Diabetes Patients

The main objective of this study is to evaluate the effects on anthropometric, glucose metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2 diabetes patients following a chronologically scheduled pattern.

Read the detailed description

Type 2 diabetes prevalence in adults has grown in the last years in many societies, accompanying the high incidence of obesity-related and other cardiovascular risk factors. Indeed, obesity is the most relevant overnutrition disease worldwide, being more dramatic than a self-esteem problem or an aesthetic issue, since it is associated to different metabolic disorders such as coronary diseases, hypertension, certain tumors, dislipidemia, biliary disorders, immunodeficiencies and insulin resistance. Different studies have shown the efficacy of low-fat diets on weight reduction, which has been associated to an improvement in overweight-related chronic pathological conditions. Additionally, a moderate increase of protein content (up to 30% of total caloric intake) in the diet and the inclusion of low-glycemic index products have been shown as a good tool for weight loss and maintenance. Recent studies have also shown the benefits of partial nutritional interventions, mainly on modifying breakfast intake, on anthropometrical and cardiovascular risk factors in overweight patients.

The study has been designed as a longitudinal nutritional intervention with two consecutive 4-week periods: from week 0 to 4, volunteers will follow their habitual diet. The second period (week 4 to 8), the volunteers' habitual breakfast, mid-morning and afternoon snacks will be substituted by 40-30-30 products, without changing any other parameter of their habitual diet or lifestyle.

Being tested
Chronologically scheduled snacking with 40-30-30 products
Keywords
chrononutrition, moderately high protein, glycemic index, type-2 diabetes, overweight, obesity, weight management
Medical subject headings
Overweight, Obesity

What participants receive

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

  • Chronologically scheduled snacking with 40-30-30 productsOther

    Also called Enervit, Zone diet

    Short-term analysis of the effects of the substitution of the habitual breakfast, mid-morning and afternoon snack of type-2 diabetes patients by 40-30-30 products. Longitudinal 2-period study

What is being measured

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

  1. Total Body weight

    Total body weight will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  2. Fat Mass

    Fat Mass will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  3. Fat-free mass

    Fat-free mass will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

Secondary outcomes (15)

  1. Hip circumference

    Hip circumference will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  2. Waist circumference

    waist circumference will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  3. Basal glucose concentration

    Basal glucose concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  4. Basal Insulin Concentration

    Basal insulin concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  5. HOMA-IR index

    HOMA-IR index will be calculated based on basal glucose and insulin levels, at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  6. Glucose postprandial response

    Glucose concentrations will be analysed during the postprandial period after the habitual and the intervention breakfast intake at the end of both periods (weeks 4 and 8). Blood extractions will be performed at 0, 30, 60 and 120 minutes after the ingestion of the breakfasts

    Measured: weeks 4 and 8

  7. Insulin postprandial response

    Insulin concentrations will be analysed during the postprandial period after the habitual and the intervention breakfast intake at the end of both periods (weeks 4 and 8). Blood extractions will be performed at 0, 30, 60 and 120 minutes after the ingestion of the breakfasts

    Measured: weeks 4 and 8

  8. Basal Total Cholesterol

    Total cholesterol concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  9. HDL-Cholesterol

    HDL-cholesterol concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  10. Triglycerides Levels

    Triglycerides concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  11. LDL-cholesterol

    LDL-cholesterol concentration will be calculated based on the FRiedewald Formula at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  12. C-Reactive Protein

    C-Reactive Protein concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  13. Homocystein

    Homocystein concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

    Measured: weeks 0, 4 and 8

  14. Dietary intake

    Dietary intake will be evaluated through 72h food records, which will be filled by the volunteers during 3 days in the habitual intake period (week 0-4) and during the intervention period (week 4-8)

    Measured: during first period (week 0-4) and second period (week 4-8)

  15. Satiety assessment

    During the postprandial period after the ingestion of the habitual breakfast (week 4) and the 40-30-30 breakfast (week 8), volunteers will fill a total of four Visual Analogue Scale (VAS) questionnaires, at times 0, 30, 60 and 120 minutes.

    Measured: weeks 4 and 8

Timeline

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

  1. First posted21 Dec 2010 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2010
  4. Study completionSep 2010

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01264523
Sponsor's protocol ID
UNAV-ROVI-001-2010
Status last verified
Sep 2012
First submitted
20 Dec 2010
Last updated
10 Sep 2012
Results posted
No

Publications

  • Navas-Carretero S, Abete I, Zulet MA, Martinez JA. Chronologically scheduled snacking with high-protein products within the habitual diet in type-2 diabetes patients leads to a fat mass loss: a longitudinal study. Nutr J. 2011 Jul 14;10:74. doi: 10.1186/1475-2891-10-74.

    PubMed 21756320

Questions about this trial

What is this clinical trial studying?

A study testing Chronologically scheduled snacking with 40-30-30 products in people with Type-2 Diabetes and Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

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 6 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 Sep 2012. 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 Spain. 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?

Total Body weight (time frame: weeks 0, 4 and 8). The study lists 3 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 NCT01264523, 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 10 Sep 2012.

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