Fasting-mimicking Diet and Longevity Diet, Body Composition and Aging

Inclusion Criteria:

• Subjects of 30-65 years of age;
• Body mass index equal to or greater than 25 kg/m2. And at least one of the following:
• Obesity (Body mass index equal to or greater than 30 kg/m2).
• HbA1C greater than 5.6%;
• IGF-1 level greater than 200 ngml-1;
• Systolic blood pressure >130 mmHg and diastolic blood pressure >90 mmHg;
• Triglycerides >150 mgdl-1;
• C-reactive protein >1 mgL-1;
• Total cholesterol >190 mgdL-1 and LDL cholesterol >129 mgdL-1.

Exclusion Criteria:

• individuals with a family member already included in the study;
• individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy,oats, sesame, or celery/celeriac;
• pregnant females;
• Individuals with any documented cancer diagnosis within the past 5 years;
• documented myocardial infarction within past 5 years;
• documented cerebrovascular accident within past 5 years;
• chronic steroid use (longer than 45 consecutive days);
• insulin-dependent diabetes mellitus;
• individuals taking insulin or insulin-like drugs and individuals taking hypoglycemicagents other than metformin. In this last case, close attention will therefore be paidto the self-monitoring of blood glucose during the FMD cycles;
• Individuals with severe hypertension (systolic greater than 200 mmHg and or diastolicgreater than 105 mmHg.
• Change in prescription medications, over-the-counter (OTC) medications, medicalfoods, and nutritional supplements within 30 days prior to the start and for theduration of the study.
• Use of medications classified as narcotics 15 days prior start and for theduration of the study.
• Use of prescription medications and/or over-the-counter medications for acute andsemi- acute medical conditions 15 days prior to start and for the duration of thestudy.
• Use of acetaminophen is permitted on an as-needed basis.
• Use of an investigational drug or participation in an investigational studywithin 30 days prior to the start and for the duration of the study.
• Use of oral or injectable corticosteroids within 30 days prior to the start andfor the duration of the study.
• Use of anticoagulant medications (heparin compounds or warfarin) within 30 daysprior to the start and for the duration of the study. Use of aspirin 81 mg or 325mg once daily is permitted.
• Use of neuroactive prescription medications including major and atypicalantipsychotic medications, anti-depressants, anti-anxiolytics, and epilepsymedications within 30 days prior to the start and for the duration of the study.

(subjects will not be allowed to discontinue prohibited prescription medications to meetenrolment criteria).

• A history of allergy or intolerance to study products. Detailed descriptions of studyproduct are included in Section 4.1 and 4.2, appended to the Study Informed Consent.
• Clinically significant vital sign abnormalities (systolic blood pressure <90 mmHg or >200 mmHg, diastolic blood pressure <50 mmHg or >105 mmHg or resting heart rate of <50or >100 bpm) at screening visit.
• A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal,respiratory, endocrinologic, neurologic, immunologic, or hematologic disease.
• Known infection with HIV, TB or Hepatitis B or C.
• A current diagnosis or personal history of:
• Any cardiovascular disease including myocardial infarction, angina,cardiovascular surgery (within 5 years), congestive heart failure, cardiacarrhythmias or conduction abnormalities, cerebrovascular accident, transientischemic attack (TIA), or peripheral vascular disease, deep vein thrombosis orpulmonary embolus. Diabetes mellitus requiring inhaled or injected insulin.
• Any autoimmune disease such as inflammatory bowel disease (including Crohn'sdisease and/or ulcerative colitis), multiple sclerosis, rheumatoid arthritis,systemic lupus erythematosus, polymyositis, scleroderma and/or thyroiditis.
• Any significant liver or kidney disease such as cirrhosis or non-alcoholic fattyliver disease, glomerulonephritis, and/or ongoing dialysis treatment.
• Any malignancy (with the exception of adequately treated malignancies with noknown recurrence for >2 years).
• Any serious mental illness including a history of attempted suicide.
• Any medical condition that in the opinion of the primary care doctor or a specialistwould preclude safe participation in this study or interfere with compliance.
• Use of drugs of abuse (such as marijuana, cocaine, phencyclidine [PCP] andmethamphetamine) 15 days prior to Day 1 and for the duration of the study.
• History of regular intake of >14 alcoholic drinks per week for females, and >21 drinksper week for males (1 drink = 35 cl. beer, 12 cl. wine, or 30 ml. hard liquor). Technical reasons Any condition in which bioelectrical impedance testing would be impossible oruninterpretable (e.g. prostheses in extremities on both sides, limb amputation, implantedpacemaker, inability to lay still or supine, or skin defects on preferred electrodeplacement sites. Other Exclusion Criteria: Inability to comply with study and/or follow-up visits.
• Any concurrent condition (including clinically significant abnormalities in medicalhistory, physical examination or laboratory evaluations) which, in the opinion of thePI, would preclude safe participation in this study or interfere with compliance.
• Any sound medical, psychiatric and/or social reason which, in the opinion of the PI,would preclude safe participation in this study or interfere with compliance.
• Abnormal laboratory findings including: abnormal blood counts (hematocrit < 33% or > 47%; WBC < 3.0 or > 12.0 x10^3/mm3; platelets < 140 or > 500 x 10^9/L); abnormalkidney function test (creatinine > 2.5 mg/dL) or liver function test(s) (AST, ALT,alkaline phosphatase) > 1.5X the upper limit of normal; serum calcium > 11 mg/dL);serum K < 3.5 mEq/L; Na < 134 or > 148 mmolL-1 Women of Childbearing Potential Contraception: the effects of the study products on thedeveloping human fetus have not been studied extensively. For this reason, women ofchildbearing potential must agree to use adequate contraception (hormonal or barrier methodof birth control; abstinence) prior to study entry and for the duration of studyparticipation. Females of childbearing potential will have a pregnancy test prior toreceiving study products. Should a woman become pregnant or suspect she is pregnant whileparticipating in this study, she should inform study staff and her primary care physicianimmediately. Pregnancy: because there is an unknown but potential risk for adverse events in pregnantwomen during treatment with the study products, pregnant women are not eligible for studyparticipation. Breast-feeding: Because there is an unknown but potential risk for adverse events innursing infants secondary to treatment of the mother with the study products, breastfeedingmothers are not eligible for study participation.