Chrono Nutrition and Insulin Resistance in Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— Chrono  

Official title:

Effect of a Chrono Nutrition Intervention on Insulin Resistance in Adults With Type 2 Diabetes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06163248
• Other study ID #: 4494
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2023
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Type 2 diabetes (T2D) is considered one of the main public health problems. During the last decade the incidence of T2D has increased exponentially leading to an increased incidence in cardiovascular disease, premature death, blindness and non-traumatic limb amputation. Novel therapeutic interventions have become imperative.

Dietary interventions are the cornerstone in managing and preventing T2D, however there is heterogeneity in the interventions and approaches currently available. The main objective of a dietary intervention is modest weight reduction achieved through calorie deficit and reduction in the consumption of carbohydrates and fats. Dietary interventions with a chrono nutrition focus establish an eating regime with calorie and macronutrient distribution taking into account sleeping and fasting hours, which are associated with metabolic alterations. This approach looks beyond calorie deficit and weight loss as primary outcomes.

Nutrition, physical activity, and education are fundamental pillars for achieving metabolic control in T2D. It is well-described that a nutritional treatment alone can improve glycemic control and the quality of life of patients. It is interesting to note that the timing of meals throughout the 24-hour period seems to play an important role, similar to the number of meals per day or the total calorie intake. Furthermore, the daily pattern of fasting-feeding is influenced by the sleep-wake cycle pattern, which is one of the most evident adaptations to circadian rhythms and plays a significant role in maintaining optimal health.

Interventions targeting aspects such as food type, meal timing, quality, and quantity can be a simple and promising strategy that can positively or negatively impact metabolic health, regardless of body weight modification. This evidence supports chrono nutrition as a novel strategy in the field of nutrition, primarily focusing on studying the interaction between nutrition, feeding, and the circadian rhythm. The implementation of new nutritional strategies based on circadian rhythms contributes to improving adherence to dietary treatment and preventing potential complications.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: January 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

Other:
• Chrono nutrition
An integral nutritional strategy involving timing, order and distribution of macronutrients
• Standard
Conventional nutritional strategy involving isocaloric distribution with no specific timing

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in hepatic steatosis and fibrosis (decibels and kilopascals)	Change in hepatic steatosis and fibrosis assessed with elastography	Six months
Other	Hunger and satiety (score)	Change in hunger and satiety assessed with visual analog scale for hunger and satiety	Six months
Primary	Change in insulin resistance (M value)	Change in insulin resistance (M value) assessed with an euglycemic-hyperinsulinemic clamp.	Six months
Secondary	Change in visceral adipose (liters)	Change in visceral adipose tissue amount	Six months
Secondary	Change in glycated hemoglobin (%)	Change in glycated hemoglobin	Six months
Secondary	Change in lipid profile (mg/dl)	Change in lipid profile	Six months