Personalized Nutrition Based on the Glycemic Response: Effect of Diet and Intestinal Microbiota

NCT05230342 | Active Not Recruiting DMC

• 1 other identifier: 3312
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study will investigate whether changes in the intestinal microbiota generated through a nutritional strategy based on functional foods, modifies postprandial glycemic responses in subjects with prediabetes and obesity, which in turn will generate a personalized dietary intervention through a prediction of postprandial blood glucose levels.

Conditions

Obesity; Pre Diabetes

Keywords

Postprandial Blood Glucose; Functional Food

Outcome Measures

Primary Outcomes (2)

• Area under the curve of postprandial glucose response

  Compare the effect between a nutritional strategy based on functional foods and the placebo group on postprandial glycemic response in subjects with obesity

  2 weeks

• Evaluation of the total daily interstitial glucose over 140 mg/dl

  Total daily interstitial glucose levels will be evaluated by using Continuous glucose monitoring (CGM).

  2 weeks

Secondary Outcomes (1)

• 16s ribosomal gene analysis

  2 weeks

Study Arms (2)

Nutritional strategy based on functional foods

EXPERIMENTAL

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.

Dietary Supplement: A package containing a mix of functional foods

Placebo Ingredient Group

PLACEBO COMPARATOR

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

Other: Placebo ingredient group

Interventions

A package containing a mix of functional foods DIETARY_SUPPLEMENT

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.

Nutritional strategy based on functional foods

Placebo ingredient group OTHER

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

Placebo Ingredient Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (2)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14080, Mexico

Location

Armando Roberto Tovar Palacio

Mexico City, 14080, Mexico

Location

Related Publications (12)

• Zhu J, Xing G, Shen T, Xu G, Peng Y, Rao J, Shi R. Postprandial Glucose Levels Are Better Associated with the Risk Factors for Diabetes Compared to Fasting Glucose and Glycosylated Hemoglobin (HbA1c) Levels in Elderly Prediabetics: Beneficial Effects of Polyherbal Supplements-A Randomized, Double-Blind, Placebo Controlled Trial. Evid Based Complement Alternat Med. 2019 Apr 15;2019:7923732. doi: 10.1155/2019/7923732. eCollection 2019.

  PMID: 31118970 RESULT

• Blaak EE, Antoine JM, Benton D, Bjorck I, Bozzetto L, Brouns F, Diamant M, Dye L, Hulshof T, Holst JJ, Lamport DJ, Laville M, Lawton CL, Meheust A, Nilson A, Normand S, Rivellese AA, Theis S, Torekov SS, Vinoy S. Impact of postprandial glycaemia on health and prevention of disease. Obes Rev. 2012 Oct;13(10):923-84. doi: 10.1111/j.1467-789X.2012.01011.x. Epub 2012 Jul 11.

  PMID: 22780564 RESULT

• Ceriello A. Impaired glucose tolerance and cardiovascular disease: the possible role of post-prandial hyperglycemia. Am Heart J. 2004 May;147(5):803-7. doi: 10.1016/j.ahj.2003.11.020.

  PMID: 15131534 RESULT

• Gallwitz B. Implications of postprandial glucose and weight control in people with type 2 diabetes: understanding and implementing the International Diabetes Federation guidelines. Diabetes Care. 2009 Nov;32 Suppl 2(Suppl 2):S322-5. doi: 10.2337/dc09-S331. No abstract available.

  PMID: 19875573 RESULT

• Eleazu CO. The concept of low glycemic index and glycemic load foods as panacea for type 2 diabetes mellitus; prospects, challenges and solutions. Afr Health Sci. 2016 Jun;16(2):468-79. doi: 10.4314/ahs.v16i2.15.

  PMID: 27605962 RESULT

• Vrolix R, Mensink RP. Variability of the glycemic response to single food products in healthy subjects. Contemp Clin Trials. 2010 Jan;31(1):5-11. doi: 10.1016/j.cct.2009.08.001. Epub 2009 Sep 6.

  PMID: 19737630 RESULT

• Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.

  PMID: 26590418 RESULT

• Mendes-Soares H, Raveh-Sadka T, Azulay S, Ben-Shlomo Y, Cohen Y, Ofek T, Stevens J, Bachrach D, Kashyap P, Segal L, Nelson H. Model of personalized postprandial glycemic response to food developed for an Israeli cohort predicts responses in Midwestern American individuals. Am J Clin Nutr. 2019 Jul 1;110(1):63-75. doi: 10.1093/ajcn/nqz028.

  PMID: 31095300 RESULT

• Christensen L, Roager HM, Astrup A, Hjorth MF. Microbial enterotypes in personalized nutrition and obesity management. Am J Clin Nutr. 2018 Oct 1;108(4):645-651. doi: 10.1093/ajcn/nqy175.

  PMID: 30239555 RESULT

• Sanchez-Tapia M, Tovar AR, Torres N. Diet as Regulator of Gut Microbiota and its Role in Health and Disease. Arch Med Res. 2019 Jul;50(5):259-268. doi: 10.1016/j.arcmed.2019.09.004. Epub 2019 Oct 5.

  PMID: 31593850 RESULT

• Kolodziejczyk AA, Zheng D, Elinav E. Diet-microbiota interactions and personalized nutrition. Nat Rev Microbiol. 2019 Dec;17(12):742-753. doi: 10.1038/s41579-019-0256-8. Epub 2019 Sep 20.

  PMID: 31541197 RESULT

• Guevara-Cruz M, Flores-Lopez AG, Aguilar-Lopez M, Sanchez-Tapia M, Medina-Vera I, Diaz D, Tovar AR, Torres N. Improvement of Lipoprotein Profile and Metabolic Endotoxemia by a Lifestyle Intervention That Modifies the Gut Microbiota in Subjects With Metabolic Syndrome. J Am Heart Assoc. 2019 Sep 3;8(17):e012401. doi: 10.1161/JAHA.119.012401. Epub 2019 Aug 27.

  PMID: 31451009 RESULT

MeSH Terms

Conditions

Obesity; Glucose Intolerance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Armando R Tovar, PhD

  Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: A team researcher will use Stata 12, to perform randomization with a 1:1 allocation using random block sizes of 4. Patients and researchers who will evaluate the outcomes and perform the statistical analysis will be blinded to the assigned group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of nutrition physiology

Model Details: The groups will receive the treatment simultaneously

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 8, 2022
• Study Start: August 2, 2022
• Primary Completion: May 31, 2025
• Study Completion: August 30, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)