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Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women

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ClinicalTrials.gov Identifier: NCT04327141
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : October 26, 2020
Sponsor:
Collaborators:
Arizona State University
Isagenix International LLC
Information provided by (Responsible Party):
Skidmore College

Brief Summary:
This study will systematically quantify the effects of protein pacing and intermittent fasting (PP-IF) on total and regional (abdominal) body composition (lean mass and fat mass), blood glucose and lipids, and anti-aging biomarkers, hunger ratings, and the gut microbiome in 40 overweight/obese adult men (n=20) and women (n=20) following a 8-week weight loss intervention. Participants will be enrolled in the study as a single cohort and participate in a 8-week weight loss (WL) trial consisting of a single dietary intervention phase.

Condition or disease Intervention/treatment Phase
Weight Loss Gut Microbiome Anti-Aging Behavioral: PP-IF Behavioral: HH Not Applicable

Detailed Description:

Previous research has shown combined protein pacing and intermittent fasting (PP-IF; 1-2 days per week) combined with moderate (20-30%) caloric restriction (CR) favorably enhance weight loss, body composition, cardiometabolic disease risk, oxidative stress, and toxin levels compared to a heart healthy diet in obese individuals following both weight loss and weight loss maintenance (Arciero et al. 2016; He et al. 2017; Zuo et al. 2016). However, less is known about whether a low sugar intake with this dietary pattern induces other significant health improvements, such as enhanced brain health (mood state), as well as gut microbiome and anti-aging indices, compared to a heart healthy diet. The novelty of the current proposal is of particular relevance and importance given the heightened popularity of low sugar dietary patterns shown to enhance health status. Most notably, among these low sugar diets touting the health benefits, are the ketogenic, paleolithic and Mediterranean diets. In addition, there is a great deal of public health emphasis on reducing overall carbohydrate intake, especially simple sugars, to improve cardiometabolic, gut, and body composition health. The dangers of high simple sugar intake are numerous, including increased risk for cardiometabolic disease (high blood lipids, hyperglycemia, insulin resistance, systemic inflammation, oxidative stress, obesity, elevated visceral fat, etc.). Thus, improvements in body composition and reductions in disease risk provides compelling evidence to pursue this study with vigor so as to generate a viable and healthy weight and fat loss strategy over the long term.

The purpose of this study is to compare the effects of a low sugar protein pacing, intermittent fasting (PP-IF) diet versus a heart healthy (HH) diet on indices of body weight, total and regional body composition, mood state, anti-aging, and cardiometabolic outcomes, and the gut microbiome during weight loss (0-8 weeks). Specifically, this study aims to compare a PP-IF diet comprised of a calorie-restricted (1500 calories/day women; 1800 calories/day men) protein pacing diet (PP, 4 meals/day women, 5 meals/day men) followed by a fast (IF, ~350-450 kcals/day) compared to an established calorie-restricted (1200 calories/day for women; 1500 calories/day men) heart healthy (HH) diet. The PP-IF group will be divided into two subgroups for weeks 1-4. One subgroup will consist of five days of PP and two days of IF, and the second subgroup will consist of six days of PP and one day of IF. For weeks 5-8 both subgroups will follow 6 days of a PP diet and 1 day IF.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 40 overweight/obese adult men (n=20) and women (n=20) will be quasi-randomized to one of the two groups matched by sex (men/women) and body weight. Participants will be enrolled in the study as a single cohort and participate in a 8-week weight loss (WL) trial consisting of a single dietary intervention phase.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Protein Pacing, Intermittent Fast Versus Heart Healthy Diet on Body Weight, Body Composition, Cardiometabolic and Brain Health, and Gut Microbiome, in Overweight Men and Women During Weight Loss
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Protein pacing and intermittent fasting
During the 8-week weight loss (WL) phase, participants assigned to the PP-IF will consist of PP days, whereby female participants will consume four and male participants will consume five meals/snacks total, two of which (breakfast and lunch) will include a protein powder meal replacement mixed with water (240-400 kcals per meal) along with an evening dinner meal (~500 kcals), an afternoon snack (men only), and an evening snack (250 kcals). Subjects will be calorie restricted to ~1500 and ~1800 calories per day, women and men, respectively during PP days. For each IF day, subjects will be provided a variety of supplements/snacks made by Isagenix International LLC. The PP-IF group will be further divided into two subgroups for weeks 1-4. One subgroup will consist of five days of PP and two days of IF, and the second subgroup will consist of six days of PP and one day of IF. For weeks 5-8 both subgroups will follow 6 days of a PP diet and 1 day IF.
Behavioral: PP-IF
Protein pacing and intermittent fasting

Experimental: Heart Healthy
The HH group will observe the dietary guidelines in compliance with the National Cholesterol Education Program Therapeutic Lifestyle Changes (TLC) diet. This diet consists of consuming <35% of kcal as fat; 50%-60% of kcal as carbohydrates; <200 mg/dL of dietary cholesterol; and 20-30 g/day of fiber. The total calorie intake will be 1200 and 1500 calories per day, women and men, respectively during the weight loss phase (weeks 0-8).
Behavioral: HH
Heart Healthy




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: 0 weeks, 4 weeks, 8 weeks ]
    Total body weight measurement


Secondary Outcome Measures :
  1. Change in total and regional body fat and lean body mass [ Time Frame: 0 weeks, 8 weeks ]
    Quantitative measure of total body fat and lean mass using iDXA (dual x-ray absorptiometry)

  2. Changes in feelings of hunger, fullness, satiety scores measured with a visual analog scale [ Time Frame: 0 weeks, 4 weeks, 8 weeks ]
    Hunger ratings using a visual analog scale ranging from 0-100 mm. A score closer to 0mm indicates no level of hunger related feelings and a score of 100 mm indicates extreme hunger-related feelings

  3. Change in blood lipid levels [ Time Frame: 0 weeks, 4 weeks, 8 weeks ]
    Blood draw for measurement of total cholesterol, HDL-C, LDL-C, triglycerides using a Cholestech Alere

  4. Change in gut microbiome [ Time Frame: 0 weeks, 4 weeks, 8 weeks ]
    Fecal gut microbiome communities will be sequenced using microbial DNA extracted from samples at 0, 4, and 8 weeks for each study arm. Amplified copies of the 16S rRNA gene will be evaluated for treatment differences in alpha (within-sample richness and evenness) and beta diversity (between-sample community structure). Relative and differential abundance of individual microbial taxa will also be measured.

  5. Change in blood pressure [ Time Frame: 0 weeks, 4 weeks, 8 weeks ]
    Quantitative measure of blood pressure using automated blood pressure monitor called a mobiligraph for 1 minute

  6. Change in heart rate [ Time Frame: 0 weeks, 4 weeks, 8 weeks ]
    Quantitative measure of heart rate using automated heart rate monitor called a mobiligraph for 1 minute

  7. Change in fat mass and muscle mass [ Time Frame: 0 weeks, 4 weeks, 8 weeks ]
    Quantitative measure of total body fat and muscle mass using BODPod (air displacement plethysmography)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Type II Diabetes
  • Emphysema
  • Significant heart disease (CABG, CHF, VFib, Hypercholesterolemia, Uncontrolled High Blood Pressure, etc.)
  • COPD
  • Cancer or undergoing treatment for cancer
  • Allergies to milk or milk products, sugar alcohols, fructose, or gluten
  • Anorexia or Bulimia
  • Fasting intolerances/hypoglycemia
  • Pregnant or plan to become pregnant during 8-week study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327141


Contacts
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Contact: Paul J Arciero, PhD 5188590935 parciero@skidmore.edu
Contact: Karen M Arciero, DPT 5188590934 karciero@skidmore.edu

Locations
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United States, New York
Human Nutrition and Metabolism Laboratory Recruiting
Saratoga Springs, New York, United States, 12866
Contact: Paul J Arciero, PhD    518-580-5366    parciero@skidmore.edu   
Contact: Karen M Arciero, DPT    5188590934    karciero@skidmore.edu   
Principal Investigator: Paul J Arciero, PhD         
Sponsors and Collaborators
Skidmore College
Arizona State University
Isagenix International LLC
Investigators
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Principal Investigator: Paul J Arciero, PhD Skidmore College
Publications:
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Responsible Party: Skidmore College
ClinicalTrials.gov Identifier: NCT04327141    
Other Study ID Numbers: 1911-859
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes