AzTrials
AzTrials

Alzheimer's DiseaseNCT02460783

Intermittent Calorie Restriction, Insulin Resistance, and Biomarkers of Brain Function

A study testing Boost (R) 5-2 diet and Healthy Living Diet in people with Alzheimer's Disease and Obesity, run by National Institute on Aging (NIA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells may not respond to insulin normally. It can lead to serious diseases. Researchers want to see how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s disease. Read more about this study

Who is it for?
Ages 55 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease, Obesity, Diabetes Mellitus
What is being tested?
Boost (R) 5-2 diet and Healthy Living Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteUnited States
Study dates
22 Jun 2015to 23 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI greater than or equal to 27; in addition, weight less than or equal to 350 lbs (weight limit for MRI scanner);
  • Age of 55-70 years;
  • HOMA-IR greater than or equal to 1.8;
  • MMSE greater than or equal to 26

Who cannot join

  • History of clinically significant cardiovascular disease for the purpose of this study, such as chronic heart failure, coronary disease, cardiomyopathy, clinically significant cardiac valvular disease or clinically significant peripheral vascular disease. Cardiovascular conditions that are clinically non-significant for the purpose of this study, such as controlled hypertension, minor EKG abnormalities, mitral valve prolapse or benign murmurs are permissible;
  • History of clinically significant stroke or other neurological disease of the central nervous system;
  • History of substance abuse in the past 6 months or positive urine drug screen;
  • History of clinically significant endocrine disorders (common mild endocrine disorders, such as untreated subclinical hypothyroidism with TSH < 10 mU/l or successfully treated hypothyroidism may be allowed);
  • History of eating disorders, significant GI disorders or malabsorption disorders;
  • History of type 2 diabetes; and/or use of anti-diabetes medications or insulin; and/or type 2 diabetes diagnosed during the screening visit based on fasting glucose > 125 mg/dL;
Show all 15Show fewer
  • History of hypoglycemia; and/or a fasting glucose < 70 mg/dL during the screening visit.
  • Current use of systemic corticosteroids;
  • Positive screening tests for HIV, HCV or HBV;
  • Hematocrit less than 35% or hemoglobin less than 11 mg/dL;
  • ALT or AST > 1.5 times the upper normal limit;
  • Contraindications for MRI (pacemakers, ferrous metal implants or shrapnel in or around the head, etc.).
  • Contraindications to LP, such as Coumadin, coagulopathy (international normalized ratio, or INR > 1.5; prothrombin time (PT), partial prothrombin time (PTT) > 1.5 x upper normal limit). Aspirin 81 mg qd is allowed. Aspirin up to 325 mg qd is allowed, if withheld for 7 days prior to the LP.
  • Pregnancy or nursing.
  • Refusal to consent to genetic testing for APOE.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institute of Aging, Clinical Research Unit

    Baltimore, Maryland, 21224

Other trials in United States

About this study

Background:

  • Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells may not respond to insulin normally. It can lead to serious diseases. Researchers want to see how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s disease.
Read more

Objectives:

  • To compare two forms of diet and their effects on insulin resistance and the brain.

Eligibility:

  • Women ages 55 70 with insulin resistance.

Design:

  • This study requires 6 clinic visits over 9 12 weeks. Participants must fast before visits.
  • Visit 1, screening:
  • Medical history, physical exam, and blood and urine tests.
  • Participants will get a wrist device to wear for 4 days.
  • Visit 2:
  • Weight and waist measurement.
  • Blood drawn.
  • Questionnaires and thinking tests.
  • Lumbar puncture. Skin will be numbed and a needle inserted between bones in the back will remove <TAB>fluid.
  • Participants will drink a nutrition shake. Blood will be taken 12 times over 4 <TAB>hours through a thin tube in <TAB>the arm.
  • Brain MRI. Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field. <TAB>They will have a coil on their head and may do tasks.
  • Participants will get advice about healthy eating and be randomly put in one of 2 groups. One group will get <TAB>nutrition shakes to drink.
  • Visits 3 5:
  • Weight and waist measurements, vital signs, blood draw, and questionnaires.
  • Between visits, participants will get a call or email to check how they are doing.
  • Visit 6: Repeat of visit 1.
  • Participants will wear the wrist device for 4 more days, have a follow-up contact, then the study is finished.
Read the detailed description

Being overweight or obese can cause insulin resistance (IR), which is defined as reduced responsiveness to insulin by the cells of various tissues or organs. IR at midlife increases the risk of developing Alzheimer s disease (AD). We recently discovered novel biomarkers of brain IR (altered Tyr and Ser phosphorylated forms of insulin receptor substrate 1; IRS-1) in plasma exosomes enriched for neuronal origin. Moreover, IR is associated with AD biomarkers including deficits in resting state brain activity and cognitive performance. Calorie restriction is defined as consuming fewer calories than what is considered normal without a lack of nutrients. A certain type of calorie restriction, in which one consumes 500-600 calories a day for two consecutive days, followed by non-restricted eating for 5 days (5-2 CR), has been shown to lower peripheral insulin resistance effectively. Effects of CR and lowering peripheral IR on brain IR and cognition are unknown. The goal of this exploratory pilot study is to provide proof-of-concept that 5-2 CR at midlife can reverse brain IR, lower peripheral IR, improve cognitive performance, and increase brain activation at rest and during tasks. Specifically, we will study the effects of 8 weeks of 5-2 CR versus a control dietary intervention on brain and peripheral IR, memory and executive function, resting state default mode network activity, brain metabolism, and AD biomarkers. Forty overweight to obese women and men (between 55 and 70 years of age) will be randomized 1:1 into 5-2 CR and control groups. In the 5-2 CR group, participants will be offered healthy living dietary counseling at baseline, which they will be instructed to implement for five days/week. For each of the other two consecutive days/week, they will consume two shakes (Boost , CWI Medical), providing a total of 480 Kcal/day. In the control group, participants will be offered healthy living dietary counseling at baseline, which they will be asked to implement for every day of the week. Participants will undergo screening including a history and physical examination, calculation of Body Mass Index (BMI, which must be greater than or equal to 27) and a blood draw for insulin and glucose to determine whether they have insulin resistance. If participants meet eligibility criteria, they will continue with a baseline visit involving anthropometric measures, questionnaires, tests of cognitive function, brain MRI, blood draws for plasma and peripheral blood mononuclear cells, and lumbar puncture for cerebrospinal fluid biomarkers of AD. After 8 weeks, we will collect the same measures. To assess and reinforce compliance with their respective diet, participants will come into the clinic every 2 weeks to discuss compliance, measure their body weight and perform blood draws for measurement of ketones to objectively confirm energy restriction for the 5-2 CR group. We will also contact participants every week to further ensure compliance. To assess the effects of the diets on physical activity, participants will be asked to wear an accelerometer for 96 hours before and after they are on the diet.

Being tested
Boost (R) 5-2 diet, Healthy Living Diet
Keywords
Biomarkers, Diabetes, Obesity, Dementia of the Alzheimer Type, Functional Magnetic Resonance Imaging (fMRI)
Medical subject headings
Alzheimer Disease, Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boost (R) 5-2 dietOther

    Also called 5-2 Intermittent Fasting (IF)

    Regular diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week. Supplement providing 240 Kcal per shake. Participant takes 2 shakes per calorie restriction day.

  • Healthy Living DietOther

    Counseling and educational material on diet portion, consistency

Study groups in NCT02460783
Study groupRoleWhat they receive
5-2 CRExperimentalHealthy living diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week.
Receives: Other: Boost (R) 5-2 diet
Healthy Living DietActive comparatorHealthy living diet for 7 days/week
Receives: Other: Healthy Living Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine312-insulin Receptor Substrate-1 (pS312-IRS-1)

    IRS-1 is an intracellular adaptor molecule that is being recruited and activated by the binding of insulin and insulin-like growth factor to their respective receptors and in insulin resistance (IR) it shows aberrant phosphorylation in serine residues resulting in impaired downstream signal propagation. pS312-IRS-1 is considered an index of brain insulin resistance and a therapeutic response biomarker for interventions targeting brain IR. A decrease in its levels indicates target engagement with the intervention and improvement in brain IR.

    Measured: Week 0, Week 4, Week 8

  2. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) P-pan-Tyrosine-IRS-1 (pY-IRS-1)

    IRS-1 is an intracellular adaptor molecule that is being recruited and activated by the binding of insulin and insulin-like growth factor to their respective receptors and in insulin resistance (IR) it shows aberrant phosphorylation in tyrosine residues resulting in impaired downstream signal propagation. pY-IRS-1 is considered an index of brain insulin resistance and a therapeutic response biomarker for interventions targeting brain IR. A decrease in its levels indicates target engagement with the intervention and improvement in brain IR.

    Measured: Week 0, Week 4, Week 8

Secondary outcomes (90)

  1. Mean Change in Body Weight

    Measured: Week 0, Week 8

  2. Mean Change in Body Mass Index (BMI)

    Measured: Week 0, Week 8

  3. Mean Change in Waist Circumference

    Measured: Week 0, Week 8

  4. Mean Change in Fasting Glucose

    Measured: Week 0, Week 8

  5. Mean Change in Fasting Insulin

    Measured: Week 0, Week 8

  6. Mean Change in Homeostatic Model Assessment of Insulin Resistance 2 (HOMA2-IR)

    Homeostatic Model Assessment of Insulin Resistance Index 2 (HOMA2-IR) is a marker of peripheral insulin resistance and is calculated by fasting insulin (μIU/L) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. A cut-off of 1.8 was used to indicate peripheral insulin resistance.

    Measured: Week 0, Week 8

  7. Mean Change in Glycosylated Hemoglobin (HbA1c)

    Measured: Week 0, Week 8

  8. Mean Change in White Blood Cells (WBCs)

    Measured: Week 0, Week 8

  9. Mean Change in Red Blood Cells (RBCs)

    Measured: Week 0, Week 8

  10. Mean Change in Platelets

    Measured: Week 0, Week 8

  11. Mean Change in Hemoglobin

    Measured: Week 0, Week 8

  12. Mean Change in Hematocrit

    Measured: Week 0, Week 8

  13. Mean Change in International Normalized Ratio (INR)

    The International Normalized Ratio (INR) is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. The higher the INR, the longer it takes for blood to clot.

    Measured: Week 0, Week 8

  14. Mean Change in Serum Beta-Hydroxybutyrate (bHB)

    Measured: Week 0, Week 8

  15. Mean Change in Serum Acetoacetate (AcAc)

    Measured: Week 0, Week 8

  16. Mean Change in Serum Non-Esterified Fatty Acids (NEFA)

    Measured: Week 0, Week 8

  17. Mean Change in Serum Cortisol

    Measured: Week 0, Week 8

  18. Mean Change in Creatinine

    Measured: Week 0, Week 8

  19. Mean Change in Blood Urea Nitrogen (BUN)

    Measured: Week 0, Week 8

  20. Mean Change in Alanine Aminotransferase (ALT)

    Measured: Week 0, Week 8

  21. Mean Change in Aspartate Aminotransferase (AST)

    Measured: Week 0, Week 8

  22. Mean Change in Total Cholesterol

    Measured: Week 0, Week 8

  23. Mean Change in HDL Cholesterol

    Measured: Week 0, Week 8

  24. Mean Change in LDL Cholesterol

    Measured: Week 0, Week 8

  25. Mean Change in Triglycerides

    Measured: Week 0, Week 8

  26. Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 42

    Measured: Week 0, Week 8

  27. Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 40

    Measured: Week 0, Week 8

  28. Mean Change in Cerebrospinal Fluid (CSF) Amyloid Beta 42 / Amyloid Beta 40 Ratio

    Measured: Week 0, Week 8

  29. Mean Change in Cerebrospinal Fluid (CSF) Total Tau

    Measured: Week 0, Week 8

  30. Mean Change in Cerebrospinal Fluid (CSF) p181-Tau

    Measured: Week 0, Week 8

  31. Mean Change in Cerebrospinal Fluid (CSF) Neurogranin

    Measured: Week 0, Week 8

  32. Mean Change in Cerebrospinal Fluid (CSF) Light Chain Neurofilaments (Nf-L)

    Measured: Week 0, Week 8

  33. Mean Change in Cerebrospinal Fluid (CSF) Glial Fibrillary Acidic Protein (GFAP)

    Measured: Week 0, Week 8

  34. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 42

    Measured: Week 0, Week 4, Week 8

  35. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 40

    Measured: Week 0, Week 4, Week 8

  36. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Amyloid Beta 42 / Amyloid Beta 40 Ratio

    Measured: Week 0, Week 4, Week 8

  37. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Total Tau

    Measured: Week 0, Week 4, Week 8

  38. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) p181-Tau

    Measured: Week 0, Week 4, Week 8

  39. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) p231-Tau

    Measured: Week 0, Week 4, Week 8

  40. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Akt

    Akt (or protein kinase B) is an insulin signaling cascade mediator. An increase in its levels indicates an improvement in brain insulin resistance.

    Measured: Week 0, Week 4, Week 8

  41. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine473-Akt (pS473-Akt)

    pS473-Akt is an insulin signaling cascade mediator. An increase in its levels indicates activation of downstream insulin signaling pathway.

    Measured: Week 0, Week 4, Week 8

  42. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine473-Akt (pS473-Akt) / Akt Ratio

    Measured: Week 0, Week 4, Week 8

  43. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Extracellular Signal-regulated Kinase 1/2 (pERK1/2)

    pERK1/2 is an insulin signaling cascade mediator. An increase in its levels indicates activation of downstream insulin signaling pathway.

    Measured: Week 0, Week 4, Week 8

  44. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated c-Jun N-terminal Kinase (pJNK)

    JNK is an insulin signaling cascade mediator. Activated JNK (pJNK) inhibits insulin signaling. An increase in pJNK levels indicates inhibition of downstream insulin signaling pathway.

    Measured: Week 0, Week 4, Week 8

  45. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated p38 (pp38)

    p38 is an insulin signaling cascade mediator. Activated p38 (pp38) inhibits insulin signaling. An increase in pp38 levels indicates inhibition of downstream insulin signaling pathway.

    Measured: Week 0, Week 4, Week 8

  46. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) proBDNF

    Measured: Week 0, Week 4, Week 8

  47. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) BDNF

    Measured: Week 0, Week 4, Week 8

  48. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Neurogranin

    Measured: Week 0, Week 4, Week 8

  49. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Heavy Chain Neurofilaments (Nf-H)

    Measured: Week 0, Week 4, Week 8

  50. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) A-synuclein

    Measured: Week 0, Week 4, Week 8

  51. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) TAR DNA-binding Protein 43 (TDP-43)

    Measured: Week 0, Week 4, Week 8

  52. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Monocarboxylate Transporter 1 (MCT1)

    Measured: Week 0, Week 4, Week 8

  53. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Monocarboxylate Transporter 2 (MCT2)

    Measured: Week 0, Week 4, Week 8

  54. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Mitochondrial Complex IV Quantity

    Complex IV is part of the mitochondrial electron transport chain. Decreased complex IV levels in NDEVs have been found in patients with Alzheimer's disease. A decrease in its levels may indicate decreased ability of neurons for ATP production and energy crisis.

    Measured: Week 0, Week 4, Week 8

  55. Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Mitochondrial Complex V Quantity

    Complex V is part of the mitochondrial electron transport chain. Decreased complex V levels in NDEVs have been found in patients with Alzheimer's disease. A decrease in its levels may indicate decreased ability of neurons for ATP production and energy crisis.

    Measured: Week 0, Week 4, Week 8

  56. Mean Change in Glucose by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glucose relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  57. Mean Change in N-acetyl-aspartate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. N-acetyl-aspartate relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  58. Mean Change in Lactate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Lactate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Lactate relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  59. Mean Change in Glutamate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamate relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  60. Mean Change in Gamma-Aminobutyric Acid (GABA) by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Gamma-Aminobutyric Acid (GABA) concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Gamma-Aminobutyric Acid (GABA) relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  61. Mean Change in Glutamine by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamine relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  62. Mean Change in Glutathione by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutathione concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutathione relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  63. Mean Change in Myo-Inositol by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Myo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Myo-Inositol relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  64. Mean Change in N-acetyl-aspartyl-glutamate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartyl-glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. N-acetyl-aspartyl-glutamate relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  65. Mean Change in Ascorbate by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Ascorbate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Ascorbate relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  66. Mean Change in Alanine by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Alanine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Alanine relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  67. Mean Change in Scyllo-Inositol by Proton J-PRESS MRS of Posteromedial Cortex (PMC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Scyllo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Scyllo-Inositol relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  68. Mean Change in Glucose by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glucose relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  69. Mean Change in Lactate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Lactate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Lactate relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  70. Mean Change in Glutamate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamate relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  71. Mean Change in Glutamine by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutamine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutamine relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  72. Mean Change in Glutathione by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Glutathione concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glutathione relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  73. Mean Change in Myo-Inositol by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Myo-Inositol concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Myo-Inositol relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  74. Mean Change in N-acetyl-aspartyl-glutamate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) N-acetyl-aspartyl-glutamate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. N-acetyl-aspartyl-glutamate relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  75. Mean Change in Ascorbate by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Ascorbate concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Ascorbate relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  76. Mean Change in Alanine by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) Alanine concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Alanine relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  77. Mean Change in Scyllo-Inositol by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)

    Proton J-PRESS Magnetic Resonance Spectroscopy (MRS) glucose concentrations were determined using the Prior-Knowledge Fitting Procedure (ProFit), which fits linear combinations of simulated two-dimensional basis metabolite spectra. Glucose relative ratio to creatine was quantified.

    Measured: Week 0, Week 8

  78. Mean Change in Executive Function Composite

    Executive function was assessed with the National Institutes of Health (NIH) Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) battery that comprises written, verbal, and computerized tasks that test working memory, inhibition, set shifting, fluency, planning, insight, and social cognition and behavior. The Executive function Composite is a computerized score calculated based on the individual tests. It ranges between 0 and 10. Higher score values indicate better performance.

    Measured: Week 0, Week 8

  79. Mean Change in California Verbal Learning Test (CVLT)

    California Verbal Learning Test (CVLT) assesses verbal memory for unstructured information. Examinees are asked to recall words on a 16-item list after each of 5 learning trials (Immediate Free Recall; range 0-80 [5 x 0-16]). After a distractor list, participants are again asked to recall words spontaneously (Short Delay Free Recall; range 0-16) and with category cueing (Short Delay Cued Recall; range 0-16). Spontaneous recall (Long Delay Free Recall; range 0-16) and category cueing (Long Delay Cued Recall; range 0-16) are repeated after a 20-minute delay. Following the longer delay, participants also complete a yes/no recognition trial during which they need to discriminate between the target words and 32 distractor words (Long Delay Recognition; range 0-48 [0-16 true positive target words + 0-32 true negative distractor words]). Higher scores indicate better performance.

    Measured: Week 0, Week 8

  80. Mean Change in Logical Memory (LM) Test

    Logical Memory (LM) test assesses verbal memory for structured information. It consists of two thematically independent narrative stories. Each story has 25 items, which the examinee has to recall with as much detail and precision as possible. Each item is scored the same regardless of importance level, and all correct items are summed giving a maximum score of 25 for each story. "Verbatim recall" score only includes the items that are recalled exactly and with detailed information, whereas "gist recall" score includes both the verbatim recall and the items that are recalled with only the essential elements of the information. The examinee has to recall the two stories twice, immediately after their initial administration (immediate recall) and after a 20 to 30-minute delay (delayed recall). Total maximum score for each of the subtests is 50 (25 items x 2 stories) and the minimum score is 0. Higher scores indicate better performance.

    Measured: Week 0, Week 8

  81. Change in the Positive and Negative Affect Schedule (PANAS)

    Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure to assess positive and negative affect and is an index of emotional state. For positive affect, score can range from 10 - 50, with higher scores representing higher levels of positive affect. For negative affect, score can range from 10 - 50, with lower scores representing lower levels of negative affect.

    Measured: Week 0, Week 8

  82. Mean Change in the Short Form 36-item Health Survey (SF-36)

    Short Form 36-item Health Survey (SF-36) is a gauge of physical and psychosocial effects of the interventions. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability; the higher the score the less disability.

    Measured: Week 0, Week 8

  83. Mean Change in Total Energy Expenditure

    Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.

    Measured: Week 0, Week 8

  84. Mean Change in Daily Energy Expenditure

    Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.

    Measured: Week 0, Week 8

  85. Mean Change in Hourly Energy Expenditure

    Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.

    Measured: Week 0, Week 8

  86. Mean Change in Metabolic Rate

    Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.

    Measured: Week 0, Week 8

  87. Mean Change in Time in Activity

    Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.

    Measured: Week 0, Week 8

  88. Mean Change in Total Steps

    Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.

    Measured: Week 0, Week 8

  89. Mean Change in Steps Per Minute

    Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.

    Measured: Week 0, Week 8

  90. Mean Change in Total Sedentary Bouts

    Physical activity was monitored with an Actigraph GT3X-BT accelerometer device which measures accelerations in vertical, horizontal, and anterior-posterior directions.

    Measured: Week 0, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study start22 Jun 2015
  3. Primary completion14 Jan 2022
  4. Study completion23 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02460783
Sponsor's protocol ID
150123
Other IDs
15-AG-0123
Status last verified
15 Nov 2023
First submitted
30 May 2015
Last updated
2 Apr 2024
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: .There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.

Publications

  • Kapogiannis D, Manolopoulos A, Mullins R, Avgerinos K, Delgado-Peraza F, Mustapic M, Nogueras-Ortiz C, Yao PJ, Pucha KA, Brooks J, Chen Q, Haas SS, Ge R, Hartnell LM, Cookson MR, Egan JM, Frangou S, Mattson MP. Brain responses to intermittent fasting and the healthy living diet in older adults. Cell Metab. 2024 Aug 6;36(8):1668-1678.e5. doi: 10.1016/j.cmet.2024.05.017. Epub 2024 Jun 19.

    PubMed 38901423

Questions about this trial

What is this clinical trial studying?

A study testing Boost (R) 5-2 diet and Healthy Living Diet in people with Alzheimer's Disease and Obesity, run by National Institute on Aging (NIA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine312-insulin Receptor Substrate-1 (pS312-IRS-1) (time frame: Week 0, Week 4, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02460783, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in