Bed Rest, Alternate Daily Fasting and Incretin Effect

NCT02134860 | Completed

• 1 other identifier: H-6-2014-017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Bed rest produces insulin resistance in healthy volunteers. In this study the investigators aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate daily fasting affects cognitive function and the insulin resistance produced by bed rest. The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every second (175% of daily calorie need). The investigators hypothesize:

1. 1.Bed rest reduces the incretin effect
2. 2.Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet
3. 3.Alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet

Conditions

Metabolic Syndrome; Type 2 Diabetes; Critical Illness

Outcome Measures

Primary Outcomes (3)

• Incretin effect

  Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)

  24 weeks

• Cognitive function

  Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)

  18 months

• Insulin resistance

  Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index

  12 weeks

Study Arms (2)

Isocaloric diet

ACTIVE COMPARATOR

3 daily meals

Other: Bed rest; Other: OGTT; Other: IVGTT; Other: Cognitive testing; Other: Muscle and fat biopsies; Other: Dual-energy X-ray Absorptiometry (DXA) scan; Other: MRI

Alternate daily fasting

ACTIVE COMPARATOR

One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day

Other: Bed rest; Other: OGTT; Other: IVGTT; Other: Cognitive testing; Other: Muscle and fat biopsies; Other: Dual-energy X-ray Absorptiometry (DXA) scan; Other: MRI

Interventions

Bed rest OTHER

8 days of full bed rest

Alternate daily fasting; Isocaloric diet

OGTT OTHER

Oral glucose tolerance test with 75 g of glucose before and after bed rest

Alternate daily fasting; Isocaloric diet

IVGTT OTHER

Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT

Alternate daily fasting; Isocaloric diet

Cognitive testing OTHER

Daily testing of memory and concentration using standardized tests

Alternate daily fasting; Isocaloric diet

Muscle and fat biopsies OTHER

Biopsies will be obtained before and after bed rest

Alternate daily fasting; Isocaloric diet

Dual-energy X-ray Absorptiometry (DXA) scan OTHER

DXA scan to evaluate fat and muscle distribution before and after bed rest

Alternate daily fasting; Isocaloric diet

MRI OTHER

Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest

Alternate daily fasting; Isocaloric diet

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI\<25kg/m2
• VO2 max normal for age

You may not qualify if:

• Tobacco smoking
• Alcohol ingestion \> 14 units per week
• Diabetes in nearby relatives
• Resection of the small intestine
• History of gastric bypass surgery
• Risk of deep venous thrombosis
• Female

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

  PMID: 33512717 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus, Type 2; Critical Illness

Interventions

Bed Rest; Glucose Tolerance Test; Neuropsychological Tests; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical

Study Officials

• Nina Majlund Harder-Lauridsen, MD

  Rigshospitalet, 7641

  PRINCIPAL INVESTIGATOR

• Signe Tellerup Nielsen, MD

  Rigshospitalet, 7641

  PRINCIPAL INVESTIGATOR

• Rikke Krogh-Madsen, MD. PhD

  Rigshospitalet, 7641

  PRINCIPAL INVESTIGATOR

• Bente Klarlund Pedersen, Professor

  Rigshospitalet, 7641

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 9, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

DK (1)