NCT02525419

Brief Summary

This study systematically quantified the effects of intermittent fasting and caloric restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate utilization in 43 overweight/obese middle-aged men (n=22) and women (n=21). Participants were enrolled in the study as a single cohort and participated in an 12-week trial consisting of two consecutive phases: 1) 1-week baseline, weight maintenance control phase (C), and 2) 11-week weight loss IFCR phase. During the 1 week C phase, volunteers were required to maintain their body weight by consuming their normal food intake; however, during the 11 week IFCR, subjects were instructed to consume 75% of their normal intake to result in a 1-2 lb of body weight loss per week. At the conclusion of the 12 week weight loss study, all 40 participants (3 drop-outs) were invited to enroll in a 12 month follow up study. If they agreed to participate, groups were balanced so there were similar numbers of men and women and were weight-matched. The two groups (n=37, 3 dropped prior to allocation) included: 1) a modified version of the 12 week weight loss intervention that consumes whole foods along with 2 meal replacements (rather than 3) (MR; n=19) or 2) a whole foods diet similar to the Therapeutic Lifestyle Changes diet recommended by the National Institute of Health (TLC, n= 18) and asked to follow these nutritional guidelines ad libitum for the duration of 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

August 12, 2015

Last Update Submit

August 21, 2015

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Change in Total Body Fat, kg

    Quantitative measure of total body fat using the iDXA (dual x-ray absorptiometry)

    Baseline, 12 week, 64 weeks

Secondary Outcomes (3)

  • Change in Serum Toxins

    Baseline, 12 weeks, 64 weeks

  • Change in Resting Energy Metabolism

    Baseline, 12 weeks, 64 weeks

  • Change in Body Weight, kg

    Baseline, 12 week, 64 weeks

Study Arms (2)

Weight Loss Phase

EXPERIMENTAL

12 week weight loss phase consisting of High Protein - Intermittent Fast-Low Calorie diet in 43 Obese Men and Women

Behavioral: Weight Loss Phase

Weight Loss Maintenance Phase

EXPERIMENTAL

52 week weight loss maintenance phase consisting of either High Protein - Intermittent Fast (HP-IF) or Heart Healthy (HH) diet

Behavioral: HP-IFBehavioral: HH

Interventions

Weight Loss PhaseBEHAVIORAL

High Protein, Intermittent Fast, Low Calorie Diet

Weight Loss Phase
HP-IFBEHAVIORAL

High Protein, Intermittent Fast

Weight Loss Maintenance Phase
HHBEHAVIORAL

Heart Healthy

Weight Loss Maintenance Phase

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking, healthy, but overweight/obese men and women with no known cardiovascular or metabolic diseases as assessed by a medical history and a comprehensive medical examination by their physicians
  • Sedentary or lightly active (\<30 min, 2d/wk of structured physical activity) as assessed by a Physical Activity questionnaire
  • Overweight or obese (BMI\>27.5 kg/m2; % body fat\>30%)
  • Weight stable (+/-2kg) for at least 6 months prior to beginning the study

You may not qualify if:

  • History of cardiometabolic disease (e.g. diabetes, heart disease, etc) and/or cancer and presently taking medications for these conditions
  • Pregnant or may be pregnant, are allergic to milk products or are anorexic or bulimic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition and Metabolism Laboratory

Saratoga Springs, New York, 12866, United States

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: 33512717DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Arciero, Doctorate

    Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 17, 2015

Study Start

August 1, 2013

Primary Completion

November 1, 2014

Study Completion

March 1, 2015

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

US(1)