Effects of a High-CML Diet on Absorption and Excretion Levels in Healthy Adults

NCT03208946 | Completed DMC

• 1 other identifier: CIBIUG-P32-2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of carboxymethyl-lysine (CML) on the levels of absorption and excretion of CML, and in the microbiota of healthy adults. To achieve the objective, a randomized clinical trial will be carried out. Before the intervention, subjects will have a washout period for seven days, then they will be randomly assigned to either a high-CML or to a low-CML diet for 5 days. Both groups will consume the foods provided by the researchers at the research center. Diets for this intervention will be based on an isocaloric diet that will include breakfast, lunch, snacks and dinner. Blood samples will be taken the first day, the second day of the intervention, and after the five days of the intervention. Urine and fecal samples will be taken the day before the intervention and after the intervention. CML levels will be measured by Liquid chromatography tandem-mass spectrometry in serum and urine samples to evaluate the levels of absorption and excretion. DNA extraction from the fecal sample will be carried out by a commercial kit. Bacterial log10 number of copies will be determined by using q-PCR.

Conditions

Healthy

Keywords

Advanced glycation end products; Absorption; Excretion

Outcome Measures

Primary Outcomes (2)

• Serum levels of Carboxymethyl-lysine

  Changes in serum levels of Carboxymethyl-lysine, a marker of AGEs, will be measured. Carboxymethyl-lysine serum levels will be measured by Liquid chromatography tandem-mass spectrometry.

  six days

• Urinary levels of Carboxymethyl-lysine

  Changes in urinary levels of Carboxymethyl-lysine, a marker of AGEs, will be measured. Carboxymethyl-lysine urinary levels will be measured by Liquid chromatography tandem-mass spectrometry.

  six days

Secondary Outcomes (1)

• Bacterial log10 number of copies in fecal samples

  six days

Study Arms (2)

High-CML diet

EXPERIMENTAL

An isocaloric, high-CML content diet with a distribution of 55 to 63% carbohydrates, 12 to 15% protein, 25 to 30% lipids and less than 10% saturated fat.

Other: High-CML diet

Low-CML diet

SHAM COMPARATOR

An isocaloric, low-CML content diet with a distribution of 55 to 63% carbohydrates, 12 to 15% protein, 25 to 30% lipids and less than 10% saturated fat.

Other: Low-CML diet

Interventions

High-CML diet OTHER

Participants will be randomly assigned to either a high-CML or to a low-CML diet for 5 days, and they will receive the 5 corresponding meals (breakfast, lunch, snacks and dinner) during the 5 days of the intervention. These preparations will be elaborated by a catering company with indications and supervision by the research group. The intervention will be based on an isocaloric diet with a distribution of 55 to 63% carbohydrates, 12 to 15% protein, 25 to 30% lipids and less than 10% saturated fat and it macro and micronutrients will be similar in both diets. The only difference will be the CML content.

High-CML diet

Low-CML diet OTHER

Participants will be randomly assigned to either a high-CML or to a low-CML diet for 5 days, and they will receive the 5 corresponding meals (breakfast, lunch, snacks and dinner) during the 5 days of the intervention. These preparations will be elaborated by a catering company with indications and supervision by the research group. The intervention will be based on an isocaloric diet with a distribution of 55 to 63% carbohydrates, 12 to 15% protein, 25 to 30% lipids and less than 10% saturated fat and it macro and micronutrients will be similar in both diets. The only difference will be the CML content.

Low-CML diet

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 19 to 35 years old.
• Subjects with a body mass index (BMI) of 18.5 - 25 kg / m2
• Clinically healthy subjects, without presenting chronic diseases: diabetes mellitus, renal or cardiovascular disease.
• Non-smoking subjects.
• Subjects with low alcohol consumption.
• Subjects that do not consume food supplements.
• Subjects without known food allergies.
• Subjects without lactose intolerance or other foods.
• Subjects without gastrointestinal problems.
• Subjects who do not practice 150 minutes or more a week of physical exercise

You may not qualify if:

• Subjects with less than 80% adherence to the diet.
• Subjects who do not collect their indicated urine samples.
• Subjects presenting with an allergy, or adverse event during the intervention.

Sponsors & Collaborators

• Universidad de Guanajuato: lead

Study Sites (1)

University of Guanajuato

León, Guanajuato, 37320, Mexico

Location

Study Officials

• CLAUDIA LUEVANO CONTRERAS, PhD

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

• Ma. Eugenia Garay-Sevilla, MD

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 6, 2017
• Study Start: July 6, 2017
• Primary Completion: December 10, 2017
• Study Completion: February 15, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)