Effect of an Polyphenolic Beverage in Healthy Volunteers

NCT05802472 | Active Not Recruiting DMC

• 1 other identifier: 3910
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Currently, there are different strategies to prevent the effect of beverages and foods on blood glucose levels after ingestion. In this sense, polyphenols are a promising field; these compounds are secondary metabolites produced by plants, vegetables, and fruits; of these compounds, gallic acid, quercetin, and kaempferol stand out for their antihyperglycemic characteristics through a) complex formation, b) enzymatic inhibition, c) affecting transport and, d) stimulation of the secretion of intestinal satiety hormones. Vachellia farnesiana (VF) is a shrub distributed in arid, semi-arid, and tropical regions of Mexico and the world. The polyphenols of the fruits of VF in pre-clinical studies by this research group have shown important antioxidant activity and antihyperglycemic effects. The present proposal aims to evaluate the effect of the polyphenolic extract of Vachellia farnesiana on glycemic response and to monitor liver and renal function tests as a safety control in healthy volunteers through developing a Phase I clinical study.

Conditions

Healthy; Safety Issues

Keywords

Randomized single-blind clinical trial; Vachellia farnesiana; polyphenolic beverage; Phase I

Outcome Measures

Primary Outcomes (2)

• Safety of the experimental beverage intake in healthy adults

  Safety was assessed through liver and kidney profiles (serum/urine) and adverse event questionnaires, with comparison to the control group.

  Baseline and post intake

• Impact of the experimental beverage on glycemic response.

  Changes in glucose and insulin concentration during the oral glucose tolerance test after consumption of the experimental beverage compared to the control group.

  One time only by participant

Secondary Outcomes (7)

• Blood glucose fasting

  Baseline and 72 hours post consumption of the experimental beverage.

• Oral glucose tolerance test

  One-time assessment at visit 2

• Changes in Incretin hormone

  One-time assessment at visit 2

• Liver function test in serum

  Baseline and 72 hours post consumption of the experimental beverage.

• Serum kidney function

  Baseline and 72 hours post consumption of the experimental beverage.

Study Arms (2)

Control

PLACEBO COMPARATOR

Thirty subjects were randomly assigned (Visit 1), and weight and height will be evaluated, as body composition, and blood sampling to assess glucose, liver, and kidney function. During Visit 2, and before the administration of a single water as placebo, glucose in the blood will be quantified (basal; with 12 hours of fasting); later, administer a load of 75 g of oral sucrose and after 30 minutes, the blood sample will begin at different intervals: 20, 40, 60, 90 and 120 minutes. The participant solves the food consumption frequency questionnaires during this procedure. A second blood sample will be taken 48 hours later (Visit 3). Finally, a urine sample will be taken to rule out acute kidney damage through the sensitive kidney damage biomarker (KIM-1). In addition, the participant will be interviewed to answer the adverse effects questionnaire.

Other: Polyphenolic beverage from extract of Vachellia farnesiana

Experimental beverage group

EXPERIMENTAL

Thirty subjects were randomly assigned (Visit 1), and weight and height will be evaluated, as body composition and blood sampling to assess glucose, liver, and kidney function. During Visit 2, and before the administration (1.2 mg/kg of weight) of a single infusion of the polyphenolic extract, glucose in the blood will be quantified (basal; with 12 hours of fasting); later, administer a load of 75 g of oral sucrose and after 30 minutes, the blood sample will begin at different intervals: 20, 40, 60, 90 and 120 minutes. The participant solves the food consumption frequency questionnaires during this procedure. A second blood sample will be taken 48 hours later (Visit 3). Finally, a urine sample will be taken to rule out acute kidney damage through the sensitive kidney damage biomarker (KIM-1). In addition, the participant will be interviewed to answer the adverse effects questionnaire.

Other: Polyphenolic beverage from extract of Vachellia farnesiana

Interventions

Polyphenolic beverage from extract of Vachellia farnesiana OTHER

During Visit 2. A single infusion of the polyphenolic extract was administered orally. The dose (1.2 mg/kg body weight) of lyophilized extract, which was diluted in water, was calculated considering each participant's weight.

Control; Experimental beverage group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent form
• Characteristics of interest
• Healthy volunteer subjects over 18 years of age and under 50 years of age
• Men or women
• Body mass index (BMI): greater than 18.5 and less than 24.9 kg/m2
• Fasting glucose: 70-100 mg/dL
• Alkaline phosphatase (ALP): 44 to 147 IU/L
• Alanine aminotransferase (ALT): 5 to 77 IU/L
• Aspartate aminotransferase (AST): 8 to 33 IU/L
• Total bilirubin: 1.2 mg/dL
• Indirect bilirubin: 0.2-0.7 mg/dL
• Creatinine in blood: 0.06-1.3 mg/dL
• Able to give written informed consent

You may not qualify if:

• Kidney disease diagnosed by a physician
• Diabetes Mellitus 2 diagnosed by a physician
• Ingestion of over-the-counter or prescription medications. Allopathic/ayurvedic/homeopathic/centrally acting appetite suppressants in recent months.
• Bariatric surgery (gastric bypass, sleeve gastrectomy, adjustable gastric banding, biliopancreatic diversion with duodenal switch, etc.)
• Subjects on an extreme diet or exercise regimen (\>8 hours).
• Smokers (\> two cigarettes per day)
• Patients with alcohol abuse (\>3 glasses per day or \>7 drinks per week).
• Subjects with HbA1c greater than 6.5%.
• Subjects with clinically diagnosed arterial hypertension (BP) and BP \>140/90 mm Hg.
• Subjects with diseases of the thyroid gland.
• Weight loss greater than 5% during the last six months
• Pregnant/lactating women.
• Subjects who do not give their consent to participate in the study.

Sponsors & Collaborators

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

Related Publications (4)

• Delgadillo Puga C, Cuchillo-Hilario M, Navarro Ocana A, Medina-Campos ON, Nieto Camacho A, Ramirez Apan T, Lopez-Tecpoyotl ZG, Diaz Martinez M, Alvarez-Izazaga MA, Cruz Martinez YR, Sanchez-Quezada V, Gomez FE, Torre-Villalvazo I, Furuzawa Carballeda J, Camacho-Corona MR, Pedraza-Chaverri J. Phenolic Compounds in Organic and Aqueous Extracts from Acacia farnesiana Pods Analyzed by ULPS-ESI-Q-oa/TOF-MS. In Vitro Antioxidant Activity and Anti-Inflammatory Response in CD-1 Mice. Molecules. 2018 Sep 18;23(9):2386. doi: 10.3390/molecules23092386.

  PMID: 30231503 BACKGROUND

• Hernandez-Garcia E, Garcia A, Avalos-Alanis FG, Rivas-Galindo VM, Delgadillo-Puga C, Camacho-Corona MDR. Nuclear magnetic resonance spectroscopy data of isolated compounds from Acacia farnesiana (L) Willd fruits and two esterified derivatives. Data Brief. 2018 Dec 7;22:255-268. doi: 10.1016/j.dib.2018.12.008. eCollection 2019 Feb.

  PMID: 30591945 BACKGROUND

• Delgadillo-Puga C, Cuchillo-Hilario M, Leon-Ortiz L, Ramirez-Rodriguez A, Cabiddu A, Navarro-Ocana A, Morales-Romero AM, Medina-Campos ON, Pedraza-Chaverri J. Goats' Feeding Supplementation with Acacia farnesiana Pods and Their Relationship with Milk Composition: Fatty Acids, Polyphenols, and Antioxidant Activity. Animals (Basel). 2019 Aug 1;9(8):515. doi: 10.3390/ani9080515.

  PMID: 31374913 BACKGROUND

• Hernandez-Garcia E, Garcia A, Garza-Gonzalez E, Avalos-Alanis FG, Rivas-Galindo VM, Rodriguez-Rodriguez J, Alcantar-Rosales VM, Delgadillo-Puga C, Del Rayo Camacho-Corona M. Chemical composition of Acacia farnesiana (L) wild fruits and its activity against Mycobacterium tuberculosis and dysentery bacteria. J Ethnopharmacol. 2019 Feb 10;230:74-80. doi: 10.1016/j.jep.2018.10.031. Epub 2018 Oct 25.

  PMID: 30367988 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Block randomization. This procedure aims to ensure a periodic balance in the number of subjects assigned to each intervention group (53). The size of each block will be six individuals, and the number of blocks will be 10; the permutation of the groups was defined as Control (C) and Experimental (E). It is important to note that the blocks and permutations were randomly assigned.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Single-blind, placebo-controlled, randomized clinical trial.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 6, 2023
• Study Start: April 6, 2022
• Primary Completion: October 30, 2025
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share