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

NCT04327141 | Active Not Recruiting

• 1 other identifier: 1911-859
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will systematically quantify the effects of protein pacing and intermittent fasting (P-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. The purpose of the additional 12 month follow up case study (in addition to the initial 12-month case study period) is to scientifically document a significant weight loss and improved body composition following combined protein pacing intermittent fasting nutrition and a safe, effective exercise program in a study participant who achieved successful weight loss maintenance during the previous 12 month follow up study period.

Conditions

Weight Loss; Gut Microbiome; Anti-Aging

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Total body weight measurement

  0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study

Secondary Outcomes (9)

• Change in total and regional body fat and lean body mass

  0 weeks, 8 weeks, 1 year and 2 year of the Case study

• Changes in feelings of hunger, fullness, satiety scores measured with a visual analog scale

  0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study

• Change in blood lipid levels

  0 weeks, 4 weeks, 8 weeks and every 6 months during the 2 year Case Study

• Change in gut microbiome, gastrointestinal symptoms, stool

  0 weeks, 4 weeks, 8 weeks and two month intervals during the 2 year Case Study

• Change in blood pressure

  0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study

Study Arms (2)

Protein pacing and intermittent fasting

EXPERIMENTAL

During the 8-week weight loss (WL) phase, participants assigned to the P-IF will consist of P 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 P days. For each IF day, subjects will be provided a variety of supplements/snacks made by Isagenix International LLC. The P-IF group will be further divided into two subgroups for weeks 1-4. One subgroup will consist of five days of P and two days of IF, and the second subgroup will consist of six days of P and one day of IF. For weeks 5-8 both subgroups will follow 6 days of a P diet and 1 day IF.

Behavioral: P-IF

Heart Healthy

EXPERIMENTAL

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

Interventions

P-IF BEHAVIORAL

Protein pacing and intermittent fasting

Protein pacing and intermittent fasting

HH BEHAVIORAL

Heart Healthy

Heart Healthy

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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:

• 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

Sponsors & Collaborators

• Skidmore College: lead
• Arizona State University: collaborator
• Isagenix International LLC: collaborator

Study Sites (1)

Human Nutrition and Metabolism Laboratory

Saratoga Springs, New York, 12866, United States

Location

Related Publications (6)

• Arciero PJ, Edmonds R, He F, Ward E, Gumpricht E, Mohr A, Ormsbee MJ, Astrup A. Protein-Pacing Caloric-Restriction Enhances Body Composition Similarly in Obese Men and Women during Weight Loss and Sustains Efficacy during Long-Term Weight Maintenance. Nutrients. 2016 Jul 30;8(8):476. doi: 10.3390/nu8080476.

  PMID: 27483317 BACKGROUND

• He F, Zuo L, Ward E, Arciero PJ. Serum Polychlorinated Biphenyls Increase and Oxidative Stress Decreases with a Protein-Pacing Caloric Restriction Diet in Obese Men and Women. Int J Environ Res Public Health. 2017 Jan 10;14(1):59. doi: 10.3390/ijerph14010059.

  PMID: 28075418 BACKGROUND

• Zuo L, He F, Tinsley GM, Pannell BK, Ward E, Arciero PJ. Comparison of High-Protein, Intermittent Fasting Low-Calorie Diet and Heart Healthy Diet for Vascular Health of the Obese. Front Physiol. 2016 Aug 29;7:350. doi: 10.3389/fphys.2016.00350. eCollection 2016.

  PMID: 27621707 BACKGROUND

• Mohr AE, Sweazea KL, Bowes DA, Jasbi P, Whisner CM, Sears DD, Krajmalnik-Brown R, Jin Y, Gu H, Klein-Seetharaman J, Arciero KM, Gumpricht E, Arciero PJ. Gut microbiome remodeling and metabolomic profile improves in response to protein pacing with intermittent fasting versus continuous caloric restriction. Nat Commun. 2024 May 28;15(1):4155. doi: 10.1038/s41467-024-48355-5.

  PMID: 38806467 DERIVED

• Mohr AE, Jasbi P, Bowes DA, Dirks B, Whisner CM, Arciero KM, Poe M, Gu H, Gumpricht E, Sweazea KL, Arciero PJ. Exploratory analysis of one versus two-day intermittent fasting protocols on the gut microbiome and plasma metabolome in adults with overweight/obesity. Front Nutr. 2022 Oct 26;9:1036080. doi: 10.3389/fnut.2022.1036080. eCollection 2022.

  PMID: 36386914 DERIVED

• Arciero PJ, Arciero KM, Poe M, Mohr AE, Ives SJ, Arciero A, Boyce M, Zhang J, Haas M, Valdez E, Corbet D, Judd K, Smith A, Furlong O, Wahler M, Gumpricht E. Intermittent fasting two days versus one day per week, matched for total energy intake and expenditure, increases weight loss in overweight/obese men and women. Nutr J. 2022 Jun 4;21(1):36. doi: 10.1186/s12937-022-00790-0.

  PMID: 35658959 DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul J Arciero, PhD

  Skidmore College

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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. A single male participant from the original P-IF group will continue following the identical P-IF from the original 4-8 week phase and 12 month follow up period (5-6 days of P; 1-2 day of IF) for an additional 12 month period (beyond the initial 12 monthfollow up case study period). The participant will consume the identical P-IF meal plan as the original 8 week study and 24 month follow up.

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 30, 2020
• Study Start: September 3, 2020
• Primary Completion: April 1, 2023
• Study Completion: December 31, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)