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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05230342




Registration number
NCT05230342
Ethics application status
Date submitted
7/01/2022
Date registered
8/02/2022

Titles & IDs
Public title
Personalized Nutrition Based on the Glycemic Response: Effect of Diet and Intestinal Microbiota
Scientific title
Personalized Nutrition Based on the Glycemic Response: Effect of Diet and Intestinal
Secondary ID [1] 0 0
3312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Pre Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - A package containing a mix of functional foods
Other interventions - Placebo ingredient group

Experimental: Nutritional strategy based on functional foods - Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein and genistein.

Placebo comparator: Placebo Ingredient Group - The placebo group will receive a comparable set of food items that contain an equivalent number of calories per portion but without the added functional ingredients


Treatment: Other: A package containing a mix of functional foods
Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein and genistein.

Other interventions: Placebo ingredient group
The control group will receive a comparable set of food items that contain an equivalent number of calories per portion but without the added functional ingredients
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the curve of postprandial glucose response
Timepoint [1] 0 0
2 weeks
Primary outcome [2] 0 0
Evaluation of the total daily interstitial glucose over 140 mg/dl
Timepoint [2] 0 0
2 weeks
Secondary outcome [1] 0 0
16s ribosomal gene analysis
Timepoint [1] 0 0
2 weeks

Eligibility
Key inclusion criteria
* Male and female.
* Adults between 18 and 60 years of age.
* BMI = 30 and = 50 kg/m2.
* Basal blood glucose 100 - 125 mg/dl
* The signing of the informed consent.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with any type of diabetes.
* Patients with high blood pressure.
* Patients with acquired diseases secondarily producing obesity and diabetes.
* Patients who have suffered a cardiovascular event.
* Patients with gastrointestinal diseases.
* Weight loss > 3 kg in the last 3 months.
* Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
* Pregnancy status.
* Positive smoking.
* Drug treatment:

* Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitor, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
* Treatment with hypoglycemic agents (sulfonylureas, methylalanines , biguanides, incretins) or insulin and antidiabetic drugs.
* Treatment with statins, fibrates or other drugs to control dyslipidemia.
* Use of antibiotics in the three months prior to the study.
* Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy.
* Anorexigenic or that accelerate weight loss such as orlistat.
* Supplements with any of the functional foods used in the study.
* Probiotic, prebiotic or symbiotic supplements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Mexico
State/province [1] 0 0
Mexico City

Funding & Sponsors
Primary sponsor type
Other
Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Armando R Tovar, PhD
Address 0 0
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Zhu J, Xing G, Shen T, Xu G, Peng Y, Rao J, Shi R.... [More Details]
Journal Blaak EE, Antoine JM, Benton D, Bjorck I, Bozzetto... [More Details]
Journal Ceriello A. Impaired glucose tolerance and cardiov... [More Details]
Journal Gallwitz B. Implications of postprandial glucose a... [More Details]
Journal Eleazu CO. The concept of low glycemic index and g... [More Details]
Journal Vrolix R, Mensink RP. Variability of the glycemic ... [More Details]
Journal Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D... [More Details]
Journal Mendes-Soares H, Raveh-Sadka T, Azulay S, Ben-Shlo... [More Details]
Journal Christensen L, Roager HM, Astrup A, Hjorth MF. Mic... [More Details]
Journal Sanchez-Tapia M, Tovar AR, Torres N. Diet as Regul... [More Details]
Journal Kolodziejczyk AA, Zheng D, Elinav E. Diet-microbio... [More Details]
Journal Guevara-Cruz M, Flores-Lopez AG, Aguilar-Lopez M, ... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT05230342