An interventional study of Time Restricted Eating (TRE) and Exercise in Menopause Related Conditions, Sarcopenia and Osteoporosis Postmenopausal, sponsored by Idoia Labayen. Status unknown at 1 site in Spain. Open to female participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Idoia Labayen · Not applicable, Interventional, and Treatment
The goal of this randomized controlled trial] is to investigate the effects of a 12-week time restricted eating (TRE) and exercise combined intervention, as compared to (i) TRE alone, and to (ii) Caloric Restriction (CR) plus the same exercise intervention elicited by the TRE group, on Skeletal muscle tissue (SMT) quantity, quality and function (primary outcome), Resting energy expenditure (REE) and cardiometabolic health (secondary outcomes), and miRNA biomarkers in postmenopausal women with overweight or obesity.
Time restricted eating (TRE) may be a potential lifestyle tool for the management of obesity in populations at risk of sarcopenia. However, weight loss may occur at the expense of lean mass, thus producing an undesirable reduction of Skeletal Muscle Tissue (SMT). To date, studies focused on body composition suffer from methodological shortcomings in adequate SMT quantity and quality measurement (e.g. using gold standard magnetic resonance imaging, MRI) and function, dietary intake protein counselling and the monitoring of dietary energy and macronutrient intake. Importantly, no TRE studies have been conducted in postmenopausal women with overweight who are at high risk of sarcopenia. Studies such as the one presented herein are needed to elucidate the effects of TRE on SMT and protein balance in the middle- and long-term lifestyle intervention. In addition, the potentially myoprotective roles of dietary protein and exercise need to be more cogently established within the framework of a TRE regime in populations at risk of sarcopenia. Further, the effects of TRE+exercise on SMT quantity, quality and function should be compared to currently accepted lifestyle therapy lifestyle therapy for obesity management in adults at high risk of sarcopenia (Caloric Restriction (CR) + exercise and adequate protein intake). Finally, the underlying mechanisms of SMT quantity, quality and function loss, as well as those explaining the effects of TRE and exercise are unknown. The investigators will explore circulating miRNA profiles as novel, non-invasive and feasible prognostic biomarkers of changes in SMT quantity, quality and function.
Participants: Postmenopausal women (n=78) with an absence of menses for over two years (at least stage +1a) and with overweight (BMI>25 kg/m2) or obesity (BMI>30 kg/m2 and BMI\<=40 kg/m2) will be recruited at the Endocrinology Unit of the University Hospital of Navarra.
Intervention: Participants will be randomly allocated 1:1:1 to (1) CR+exercise, (2) TRE, and (3) TRE+exercise groups. Before baseline measurements and group allocation, there will be a 2-week lead-in period where the eating window, glucose and physical activity will be continuously monitored. Thereafter, participants will follow the 12-week intervention according to their allocated group.
The three groups will receive dietary advice regarding the daily amount of high quality protein and meal-specific protein quantities. All the participants will attend a lifestyle education program based on Mediterranean diet and WHO physical activity recommendations every two weeks.
Long-term follow-up: Weight cycling is frequent in women and is associated with increased morbidity. There are no previous studies examining the persistence of the effects of TRE+exercise in the long-term. Also, it seems that the adherence to the TRE regime is higher than to the CR, but the evidence is scarce. This project will assess the main study outcomes and the adherence in order to examine the persistence and feasibility of the intervention effects 12 months after the cessation.
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Exclusion Criteria:
Behavioral: Time Restricted Eating (TRE)
Behavioral: Time Restricted Eating (TRE) · Behavioral: Exercise
Behavioral: Exercise · Behavioral: Caloric Restriction
Participants will be required to reduce their eating time window to ≤ 8 hours/day. Women can choose when to begin eating, but the last meal should be completed before or at 20:00 hours (concentrating the eating window towards the active phase confers higher cardiometabolic health benefits). Our preliminary results suggest that this eating window is feasible and safe. Participants will receive dietary advice regarding the daily amount of high quality protein and meal-specific protein quantities. All the participants will attend a lifestyle education program based on Mediterranean diet and WHO physical activity recommendations every two weeks.
Sport sciences specialists will design, supervise and monitor the concurrent exercise intervention following the 2020 WHO recommendations. The program will be tailored to the participant's ability and health, and will be focused on a gradual increase to levels that are safe. Resistance training: 3 times/week designed to manage, attenuate and even prevent the loss of skeletal muscle tissue and function. The exercise sessions will be scheduled within or immediately after their eating window in order to maximize muscular muscle protein synthesis. Morning and afternoon training schedules will be offered to participants.
Individualised intensive behavioural intervention weight loss program including CR, exercise training and lifestyle education designed according to the current guidelines. CR will be tailored to participants (objectively assessed). Diet will provide 600 kcal/day less than the individual energy requirements based on measured resting energy expenditure (indirect calorimetry) and multiplied by an activity factor obtained by accelerometry. Experienced nutritionists will design personalized and balanced CR diet, and will train the participants through the food exchange system to follow the treatment. In those cases in which the CR compromised a protein intake of at least 1.2 g/kg/day, the macronutrient percentage distribution will be modified prioritizing achieving this minimum protein intake.
Skeletal muscle tissue quantity - Baseline
Skeletal muscle tissue (Cross sectional area (cm2) and Volume (cm3)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.
Time frame: Just after the end of the 12-week intervention (+1 to +3 days)
Skeletal muscle tissue quantity - 12 weeks
Skeletal muscle tissue (Cross sectional area (cm2) and Volume (cm3)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.
Time frame: Just before the start of the 12-week intervention (-3 to -1 days), just after the end of the 12-week intervention (+1 to +3 days) and 1 year after the end of the intervention
Skeletal muscle tissue quantity - 1 year
Skeletal muscle tissue (Cross sectional area (cm2) and Volume (cm3)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.
Time frame: 1 year after the end of the intervention
Skeletal muscle tissue quality - Baseline
Intermuscular and Intramuscular adipose tissue (fat fraction(%)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.
Time frame: Just before the start of the 12-week intervention (-3 to -1 days)
Skeletal muscle tissue quality - 12 weeks
Intermuscular and Intramuscular adipose tissue (fat fraction(%)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.
Time frame: Just after the end of the 12-week intervention (+1 to +3 days)
Skeletal muscle tissue quality - 1 Year
Intermuscular and Intramuscular adipose tissue (fat fraction(%)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.
Time frame: 1 year after the end of the intervention
Lower Body Muscle function - Baseline
Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.
Time frame: Just before the start of the 12-week intervention (-3 to -1 days)
Lower Body Muscle function - 12 weeks
Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.
Time frame: Just after the end of the 12-week intervention (+1 to +3 days)
Lower Body Muscle function - 1 year
Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.
Time frame: 1 year after the end of the intervention
Upper Body Muscle function - Baseline
Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.
Time frame: Just before the start of the 12-week intervention (-3 to -1 days)
Upper Body Muscle function - 12 weeks
Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.
Time frame: Just after the end of the 12-week intervention (+1 to +3 days)
Upper Body Muscle function - 1 year
Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.
Time frame: 1 year after the end of the intervention
Handgrip Strength - Baseline
Handgrip strength will be determined by the handgrip strength test using a digital hand dynamometer (kilograms)
Time frame: Just before the start of the 12-week intervention (-3 to -1 days)
Handgrip Strength - 12 weeks
Handgrip strength will be determined by the handgrip strength test using a digital hand dynamometer (kilograms)
Time frame: Just after the end of the 12-week intervention (+1 to +3 days)
Handgrip Strength - 1 year
Handgrip strength will be determined by the handgrip strength test using a digital hand dynamometer (kilograms)
Time frame: 1 year after the end of the intervention
Resting energy expenditure
We will measure gas exchange to objectively determine REE and substrate oxidation rates using indirect calorimetry (Q-NRG, COSMED, Rome, Italy), the gold standard methodology, following standard procedures.
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
Ectopic fat
Visceral adipose tissue and liver fat will be also measured by MRI (Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology as previously described.
Time frame: Just before the start of the 12-week intervention (-3 to -1 days), just after the end of the 12-week intervention (+1 to +3 days) and 1 year after the end of the intervention
Bone Mineral Density
Bone mineral density (g/cm2) will be measured by DXA (gold standard).
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
Lean Mass
Lean mass (kg) will be measured by DXA (gold standard).
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
Bone Mineral Content
Bone mineral content (g) will be measured by DXA (gold standard).
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
Whole body fat percentage
Whole body fat percentage (%) will be measured by air displacement plethysmography (BodPod, COSMED, Rome, Italy) (gold standard).
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
Glucose homeostasis
Glucose homeostasis will be evaluated with the continuous glucose monitoring over consecutive 24h/10 days.
Time frame: Just before the start of the 12-week intervention (-12 to -3 days), just after the end of the 12-week intervention (+3 to +12 days) and 1 year after the end of the intervention
Whole body Insulin Resistance
Whole body IR with the standard 75-grams two-hour oral glucose tolerance test.
Time frame: Just before the start of the 12-week intervention (-12 to -3 days), just after the end of the 12-week intervention (+3 to +12 days) and 1 year after the end of the intervention
Serum glucose
Fasting serum samples will be used to measure glucose (mg/dl)
Time frame: Just before the start of the 12-week intervention (-12 to -3 days), just after the end of the 12-week intervention (+3 to +12 days) and 1 year after the end of the intervention
Serum Insulin
Fasting serum samples will be used to measure insulin (mg/dl)
Time frame: Just before the start of the 12-week intervention (-12 to -3 days), just after the end of the 12-week intervention (+3 to +12 days) and 1 year after the end of the intervention
Serum adiponectin
Fasting serum samples will be used to measure adiponectin (μg/ml)
Time frame: Just before the start of the 12-week intervention (-12 to -3 days), just after the end of the 12-week intervention (+3 to +12 days) and 1 year after the end of the intervention
HOMA-IR
HOMA-IR will be calculated using the following formula: \[fasting serum insulin (μU/mL) × Fasting serum glucose (mg/dL)/405\]
Time frame: Just before the start of the 12-week intervention (-12 to -3 days), just after the end of the 12-week intervention (+3 to +12 days) and 1 year after the end of the intervention
Circulating total cholesterol
Circulating total cholesterol (mg/dL) will be measured in plasma after an overnight fast.
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
LDL-Cholesterol
LDL-Cholesterol (mg/dL) will be measured in plasma after an overnight fast.
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
HDL-Cholesterol
HDL-Cholesterol (mg/dL) will be measured in plasma after an overnight fast.
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
Triglycerides
Triglycerides will be measured in plasma after an overnight fast.
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
Apolipoprotein B
Apolipoprotein B (mg/dl) will be measured in plasma after an overnight fast.
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
Apolipoprotein A
Apolipoprotein A (mg/dl) will be measured in plasma after an overnight fast.
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention
Micro RNA analyses
Expression of circulating miRNAs will be analyzed in plasma samples, using RNAseq methodology at baseline and at the end of the intervention (12-week). Briefly, total RNA will be isolate and RNA quantity and quality will be confirmed by gel electrophoresis and spectrophotometry. RNA integrity will also be assessed by 2100 Bioanalyzer of Agilent Technologies. Specific NGS library kit will be used to generate sequencing libraries. Then, fragments of 145-160bp will be selected. Library sequencing will be done on a MiSeq instrument (Illumina Inc.) using Miseq Reagent kit V3 (Illumina Inc.), 12 libraries per sequencing run will be multiplexed. Analysis of results will be performed using MiSeqReporter (MSR) software of Illumina. Sequence alignment will be done using BWA and variant calling using GATK algorithm. Changes on miRNA expression levels will be evaluated with specific software packages (SHiMPS aligner, DESeq2, miRDeep, sRNAPipe and miRNET v2.0).
Time frame: Just before the start of the 12-week intervention (-7 to -3 days) and just after the end of the 12-week intervention (+3 to +7 days)
Energy intake and macronutrient distribution
24h dietary recalls will be done to gather information about daily energy intake (kcals) and macronutrient distribution (Carbohydrate %, Protein % and fat %)
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), every 2 weeks during the 12-week intervention, just after the end of the 12-week intervention (+3 to +7 days), and 1 year after the end of the intervention
Physical activity
Participants will be asked to wear a wrist-worn GT3X+ model accelerometer (ActiGraph, Pensacola, FL, USA) for 7 consecutive days (24 h/day).
Time frame: Just before the start of the 12-week intervention (-12 to -3 days), just after the end of the 12-week intervention (+3 to +12 days) and 1 year after the end of the intervention
Adherence to lifestyle intervention
Adherence to the eating window in TRE groups will be monitored using a smartphone App over the whole intervention. Adherence to the CR will be evaluated every two weeks using 24-h dietary recalls. The attendance to the exercise sessions will be registered.
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), every 2 weeks during the 12-week intervention, just after the end of the 12-week intervention (+3 to +7 days), and 1 year after the end of the intervention
Eating behavior
Eating behavior will be assessed using the Adult Eating Behavior Questionnaire (AEBQ).
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days), and 1 year after the end of the intervention
Overall health
Overall health will be evaluated using the EuroQol 5 dimensions 5 levels (EQ-5D-5L), Rand Short Form 36 (SF-36), an adverse events questionnaire
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days), and 1 year after the end of the intervention
Chronotype
Chronotype will be subjectively assessed using the validated Munich Chronotype Questionnaire (MCTQ).
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days), and 1 year after the end of the intervention
Sleep
Sleep will be subjectively assessed using the validated Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days), and 1 year after the end of the intervention
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