NCT01264523

Brief 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 scheduled pattern.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

December 20, 2010

Last Update Submit

September 7, 2012

Conditions

Type-2 DiabetesOverweight

Keywords

chrononutritionmoderately high proteinglycemic indextype-2 diabetesoverweightobesityweight management

Outcome Measures

Primary Outcomes (3)

  • 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).

    weeks 0, 4 and 8

  • 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).

    weeks 0, 4 and 8

  • 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).

    weeks 0, 4 and 8

Secondary Outcomes (15)

  • Hip circumference

    weeks 0, 4 and 8

  • Waist circumference

    weeks 0, 4 and 8

  • Basal glucose concentration

    weeks 0, 4 and 8

  • Basal Insulin Concentration

    weeks 0, 4 and 8

  • HOMA-IR index

    weeks 0, 4 and 8

  • +10 more secondary outcomes

Interventions

Chronologically scheduled snacking with 40-30-30 productsOTHER

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

Also known as: Enervit, Zone diet

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21756320RESULT

Related Links

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alfredo Martinez, PhD

    University of Navarra

    PRINCIPAL INVESTIGATOR

  • Santiago Navas-Carretero, PhD

    University of Navarra

    STUDY CHAIR

  • Itziar Abete, PhD

    University of Navarra

    STUDY CHAIR

  • M. Angeles Zulet, PhD

    University of Navarra

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Main investigator

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 21, 2010

Study Start

September 1, 2009

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations

ES(1)