Black Bean (Phaseolus Vulgaris L.) Protein Hydrolysates Reduce Acute Postprandial Glucose Levels

NCT05869344 | Completed

• 1 other identifier: CIBIUG-P53-2018
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This work aimed to evaluate the acute effect of a black bean protein hydrolysate (BPH) on glucose levels in adults with normal glucose tolerance (NGT) and prediabetes. Twenty peptides were identified in BPH, and a followed in silico predictive digestion showed a release of several short-chain peptides with potential hypoglycemic potential. A double-blind, placebo-controlled, randomized clinical trial was conducted on 28 adults with NGT or prediabetes. After consent, participants were randomized into two groups, placebo or the corresponding 5 g BPH treatment. An oral glucose tolerance test (OGTT) (75 g glucose) was used to measure glucose tolerance before treatment. A second OGTT was used to evaluate the acute effect of the BPH, and blood samples were collected at 0, 60, 120, and 150 min, and blood glucose levels were measured.

Conditions

PreDiabetes

Keywords

Black bean; Protein hydrolysates; Prediabetes

Outcome Measures

Primary Outcomes (1)

• Glucose postprandial levels

  Glucose levels were measured

  150 minutes

Study Arms (2)

Black bean protein hydrolysates (BPH) treatment

EXPERIMENTAL

Participants received BPH (5 g powder) dissolved in 120 mL of a commercial non-caloric beverage

Dietary Supplement: Black bean protein hydrolysates (BPH)

Placebo

PLACEBO COMPARATOR

Participants received 120 mL non-caloric commercial beverage

Other: Commercial non-caloric beverage

Interventions

Black bean protein hydrolysates (BPH) DIETARY_SUPPLEMENT

Participants were blinded to treatment and received BPH (5 g powder) dissolved in 120 mL of a commercial non-caloric beverage and immediately after an oral glucose tolerance test was performed to evaluate the postprandial effect of BPH.

Black bean protein hydrolysates (BPH) treatment

Commercial non-caloric beverage OTHER

Participants were blinded to treatment and received 120 mL of a commercial non-caloric beverage and immediately after an oral glucose tolerance test was performed to evaluate the postprandial effect of placebo.

Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between the ages of 25 and 50 with overweight or obesity, according to their body mass index (BMI) (25-34.9 kg/m2)
• Participants were not included if they reported diabetes, cancer, cardiovascular disease, or other chronic diseases by self-report. Pregnant or breastfeeding women were not included.

You may not qualify if:

• Participants who did not complete the oral glucose test.

Sponsors & Collaborators

• Claudia Luévano-Contreras: lead

Study Sites (1)

Universidad de Guanajuato

León, Guanajuato, 37320, Mexico

Location

Related Publications (9)

• American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S55-S64. doi: 10.2337/dc18-S006.

  PMID: 29222377 BACKGROUND

• Udenigwe, C. C., Abioye, R. O., Okagu, I. U., & Obeme-Nmom, J. I. (2021). Bioaccessibility of bioactive peptides: Recent advances and perspectives. Current Opinion in Food Science, 39, 182-189.

  BACKGROUND

• Mojica L, Chen K, de Mejia EG. Impact of commercial precooking of common bean (Phaseolus vulgaris) on the generation of peptides, after pepsin-pancreatin hydrolysis, capable to inhibit dipeptidyl peptidase-IV. J Food Sci. 2015 Jan;80(1):H188-98. doi: 10.1111/1750-3841.12726. Epub 2014 Dec 11.

  PMID: 25495131 BACKGROUND

• Mojica L, de Mejia EG. Optimization of enzymatic production of anti-diabetic peptides from black bean (Phaseolus vulgaris L.) proteins, their characterization and biological potential. Food Funct. 2016 Feb;7(2):713-27. doi: 10.1039/c5fo01204j.

  PMID: 26824775 BACKGROUND

• Mojica L, Luna-Vital DA, Gonzalez de Mejia E. Black bean peptides inhibit glucose uptake in Caco-2 adenocarcinoma cells by blocking the expression and translocation pathway of glucose transporters. Toxicol Rep. 2018 Apr 27;5:552-560. doi: 10.1016/j.toxrep.2018.04.007. eCollection 2018.

  PMID: 29854625 BACKGROUND

• Oseguera-Toledo ME, Gonzalez de Mejia E, Amaya-Llano SL. Hard-to-cook bean (Phaseolus vulgaris L.) proteins hydrolyzed by alcalase and bromelain produced bioactive peptide fractions that inhibit targets of type-2 diabetes and oxidative stress. Food Res Int. 2015 Oct;76(Pt 3):839-851. doi: 10.1016/j.foodres.2015.07.046. Epub 2015 Aug 1.

  PMID: 28455070 BACKGROUND

• Valencia-Mejia E, Batista KA, Fernandez JJA, Fernandes KF. Antihyperglycemic and hypoglycemic activity of naturally occurring peptides and protein hydrolysates from easy-to-cook and hard-to-cook beans (Phaseolus vulgaris L.). Food Res Int. 2019 Jul;121:238-246. doi: 10.1016/j.foodres.2019.03.043. Epub 2019 Mar 20.

  PMID: 31108745 BACKGROUND

• Luna-Vital DA, Mojica L, González de Mejía E, Mendoza S, Loarca-Piña G. Biological potential of protein hydrolysates and peptides from common bean (Phaseolus vulgaris L.): A review. Food Res Int [Internet]. 2015;76(P1):39- 50.

  BACKGROUND

• Mojica L, Gonzalez de Mejia E, Granados-Silvestre MÁ, Menjivar M. Evaluation of the hypoglycemic potential of a black bean hydrolyzed protein isolate and its pure peptides using in silico, in vitro and in vivo approaches. J Funct Foods. 2017B;31:274-86.

  BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Claudia Luevano Contreras, PhD

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All participants (n=28) were randomly assigned by a staff member who had no contact with them into either a group receiving BPH treatment (5 g) or a placebo group. In this study, participants were blinded to treatment and received either BPH (5 g powder) dissolved in 120 mL of a commercial non-caloric beverage or the placebo (120 mL non-caloric commercial beverage).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department Head

Model Details: A randomized, placebo-controlled clinical trial was carried out in 28 adults (65% female) to evaluate the effect of 5 g of BPH on postprandial glucose and insulin levels. After determining the participants metabolic status, the subjects were classified as either normal glucose tolerance (n=14) or prediabetes (n=14). Consequently, seven subjects with NGT and seven subjects with prediabetes were included in each treatment group (BPH or placebo).

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 22, 2023
• Study Start: October 15, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 21, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)