Protein Supplementation and Fat Mass Loss

NCT03678701 | Unknown

• 1 other identifier: IRB2018-126
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators examined the associations between whey protein supplementation before meals with energy balance and body composition.

Conditions

Obesity

Keywords

whey protein; Obesity

Outcome Measures

Primary Outcomes (1)

• Group differences in change in body fat mass

  Fat mass will be measured using a Lunar Dual X-Ray Absorptiometry Scanner (GE Medical Systems) and the Imp SFB7 BIS (ImpediMed Ltd, Australia) at baseline, and at end of the treatment period. The outcome to be compared between groups will be change in percent fat mass from baseline to post treatment.

  Baseline, end of 6th week and end of 12th week of intervention period

Secondary Outcomes (6)

• Group differences in change in physical activity energy expenditure

  Baseline and week 7 of the intervention period

• Group differences in changes in meal satiety and hunger

  Baseline, day 14, 43 and 83 of intervention period

• Group differences in change in resting Metabolic Rate

  Baseline, and at end 12 weeks of intervention period

• Group differences in changes in food intake

  Baseline, at week 7, and at week 12 of intervention period

• Group differences in changes in grip strength

  Baseline and after the 6th and 12th week of intervention.

Study Arms (2)

Protein group

EXPERIMENTAL

The protein group will consume 30g of 100% whey protein shake 1 hour before lunch and before dinner, for 12 weeks

Dietary Supplement: Pre-meal 100% whey protein intake

Control group

NO INTERVENTION

Control group will not consume any protein supplements. They will continue the usual feeding habits

Interventions

Pre-meal 100% whey protein intake DIETARY_SUPPLEMENT

Participants in the protein group will be provided 100% whey protein powder and will be advised to drink 30g of protein dissolved in 237ml (8oz) of water, one hour before lunch and dinner.

Protein group

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 19-55 years
• Body mass index more than or equal to 23 kg/m2 for Asians and more than or equal to 25 kg/m2 for other ethnic groups up to 40 kg/m2
• Individuals who are able to speak, read and write in English

You may not qualify if:

• Lactose intolerance
• Food allergies to milk products
• Religious affiliations that include specific food guidelines.
• Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months or planning to enroll in those within next 3 months
• History of prior surgical procedure for weight control or planning to have one within next 3 months
• Weight loss or gain of \>5% of body weight in the past 6 months for any reason except post-partum weight loss.
• Current smoker or quit smoking less than 6 months prior.
• Any major disease, including:
• Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
• Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
• Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class \>2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
• Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
• Active renal disease.
• Lung disease: chronic obstructive airway disease requiring use of oxygen.
• Diagnosed diabetes (type 1 or 2).

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily J (806)834-6556

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily J Dhurandhar, PhD

CONTACT

8068346556; emily.dhurandhar@ttu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 20, 2018
• Study Start: October 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)