Chrono Nutrition and Insulin Resistance in Diabetes

NCT06163248 | Unknown DMC

• 1 other identifier: 4494
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to determine the effect of a chrono nutrition intervention compared with a usual dietary intervention on insulin resistance in individuals with type 2 diabetes with overweight or obesity over a 6-month period. The main question it aims to answer is: What is the effect of a chrono nutrition intervention compared to a standard intervention on insulin resistance in individuals with T2D (type 2 diabetes) with overweight or obesity over a 6-month period? Participants:

• Will be asked to fast for 12 hours each day. During the fasting period, they may consume non-caloric beverages such as plain water, coffee, or unsweetened tea.
• They will be asked to follow a dietary plan in which the total daily calorie intake will be calculated using indirect calorimetry, subtracting 500 calories from the total calorie amount.
• The dietary plan will have the following macronutrient distribution: 40% carbohydrates (\<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and \<10% saturated).
• The plan will consist of 3 meals: breakfast will account for 40% of the total calories. Dinner will include only 10% of the total grams of carbohydrates.
• The order of food consumption should be: 1) vegetables, 2) proteins, 3) complex carbohydrates, and 4) simple carbohydrates (fruits). Researchers will compare the chrono nutrition strategy with a standard dietary intervention to see the effect in insulin resistance.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus; Chrono nutrition; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• Change in insulin resistance (M value)

  Change in insulin resistance (M value) assessed with an euglycemic-hyperinsulinemic clamp.

  Six months

Secondary Outcomes (3)

• Change in visceral adipose (liters)

  Six months

• Change in glycated hemoglobin (%)

  Six months

• Change in lipid profile (mg/dl)

  Six months

Other Outcomes (2)

• Change in hepatic steatosis and fibrosis (decibels and kilopascals)

  Six months

• Hunger and satiety (score)

  Six months

Study Arms (2)

Chrono nutrition

EXPERIMENTAL

1. During the 6-month period, participants will be asked to fast for 12 hours each day. During the fasting period, they may consume non-caloric beverages such as plain water, coffee, or unsweetened tea. 2. The total daily calorie intake will be calculated using indirect calorimetry, considering the participant's current weight, age, sex, and physical activity level. 500 calories will be subtracted from the total calorie amount. 3. The dietary plan will have the following macronutrient distribution: 40% carbohydrates (\<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and \<10% saturated). 4. The plan will consist of 3 meals and breakfast will account for 40% of the total calories. 5. During dinner, only 10% of the total grams of carbohydrates will be included. 6. The order of food consumption should be as follows: 1) vegetables, 2) proteins, 3) complex carbohydrates, and 4) simple carbohydrates (fruits).

Other: Chrono nutrition

Standard

ACTIVE COMPARATOR

1. The total daily calorie intake will be calculated using indirect calorimetry, considering the participant's current weight, age, sex, and physical activity level. 500 calories will be subtracted from the total calorie amount. 2. The dietary plan will have the following macronutrient distribution: 40% carbohydrates (\<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and \<10% saturated). 3. The plan will consist of 3 meals with an isocaloric distribution, with each meal containing 33% of the total calories.

Other: Standard

Interventions

Chrono nutrition OTHER

An integral nutritional strategy involving timing, order and distribution of macronutrients

Chrono nutrition

Standard OTHER

Conventional nutritional strategy involving isocaloric distribution with no specific timing

Standard

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with type 2 diabetes (T2D)
• HbA1c \< 8.5%
• BMI ≥ 25 kg/m2 and \< 35 kg/m2
• Stable pharmacological treatment for the last 3 months
• Willingness to participate in the protocol.

You may not qualify if:

• Insulin treatment
• Hospitalization in the previous three months
• Disease with adverse prognosis (SIDA, cancer)
• Rheumatologic diseases under immunosuppressive treatment (SLE, RA)
• Acute infection or febrile syndrome
• Hepatic cirrhosis
• Glomerular filtration rate \<60 ml/min
• Other diabetes types (LADA, T1, MODY)
• Fasting triglycerides \>500 mg/dl
• Pregnancy
• Lactation
• Steroid treatment
• High performance athletes
• Estrogen treatment
• Weight reduction \>5% in the last three months

Sponsors & Collaborators

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

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

Location

Related Publications (5)

• Henry CJ, Kaur B, Quek RYC. Chrononutrition in the management of diabetes. Nutr Diabetes. 2020 Feb 19;10(1):6. doi: 10.1038/s41387-020-0109-6.

  PMID: 32075959 BACKGROUND

• Farshchi HR, Taylor MA, Macdonald IA. Beneficial metabolic effects of regular meal frequency on dietary thermogenesis, insulin sensitivity, and fasting lipid profiles in healthy obese women. Am J Clin Nutr. 2005 Jan;81(1):16-24. doi: 10.1093/ajcn/81.1.16.

  PMID: 15640455 BACKGROUND

• Stote KS, Baer DJ, Spears K, Paul DR, Harris GK, Rumpler WV, Strycula P, Najjar SS, Ferrucci L, Ingram DK, Longo DL, Mattson MP. A controlled trial of reduced meal frequency without caloric restriction in healthy, normal-weight, middle-aged adults. Am J Clin Nutr. 2007 Apr;85(4):981-8. doi: 10.1093/ajcn/85.4.981.

  PMID: 17413096 BACKGROUND

• Lopez-Minguez J, Saxena R, Bandin C, Scheer FA, Garaulet M. Late dinner impairs glucose tolerance in MTNR1B risk allele carriers: A randomized, cross-over study. Clin Nutr. 2018 Aug;37(4):1133-1140. doi: 10.1016/j.clnu.2017.04.003. Epub 2017 Apr 10.

  PMID: 28455106 BACKGROUND

• Jakubowicz D, Wainstein J, Landau Z, Ahren B, Barnea M, Bar-Dayan Y, Froy O. High-energy breakfast based on whey protein reduces body weight, postprandial glycemia and HbA1C in Type 2 diabetes. J Nutr Biochem. 2017 Nov;49:1-7. doi: 10.1016/j.jnutbio.2017.07.005. Epub 2017 Jul 21.

  PMID: 28863364 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Chrono nutrition intervention: Participants will be asked to fast for 12 hours each day. During the fasting period, they may consume non-caloric beverages such as plain water, coffee or unsweetened tea. They will be asked to follow a dietary plan in which the total daily calorie intake will be calculated using indirect calorimetry, subtracting 500 calories from the total calorie amount. The dietary plan will have the following macronutrient distribution: 40% carbohydrates (\<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and \<10% saturated). The plan will consist of 3 meals: breakfast will account for 40% of the total calories. Dinner will include only 10% of the total grams of carbohydrates. The order of food consumption should be: 1) vegetables, 2) proteins, 3) complex carbohydrates, and 4) simple carbohydrates (fruits).

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: December 8, 2023
• Study Start: January 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 24, 2024

Record last verified: 2023-06

Locations

ME (1)