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Completed

NCT Number: NCT03600311

Resistance Exercise and Protein During Weight Loss

The purpose of this study is to determine if post-exercise protein supplementation can rescue the anabolic response of muscle and bone to resistance exercise during caloric restriction.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Starvation

Age range

19 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall

Lincoln, Nebraska, 68583, United States

About this study

  • Preliminary Testing Prior to the study start, participants will be weighed and body composition will be determined using bioimpedance analysis. Then participants will undergo a 5RM barbell back squat exercise testing procedure.
  • Randomization

Participants will proceed through each of the following conditions lasting 3 days:

CON: Participants will be in energy balance and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g maltodextrin post-exercise.

CR+C: Participants will be restricted to 15 kcal/kg FFM/day and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g maltodextrin post-exercise.

CR+P: Participants will be restricted to 15 kcal/kg FFM/day and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g whey protein post-exercise.

  • Diet Prescription Dietary energy intake will be controlled using clinical products, maltodextrin and whey protein isolate to meet target energy intakes. Participants will receive calcium and Vitamin D supplementation throughout the study.
  • Exercise Prescription Participants will perform one bout of 5 sets of 5 repetitions of barbell back squat exercise on the morning of Day 3 each condition. Additional exercise and intense physical activity will be prohibited.
  • Assessments Body weight and composition (DXA + BIA), fasting blood draws for assessment of metabolic and anabolic hormones and questionnaires will be conducted before and after each condition. A 24-hour serial blood draw procedure will be conducted following each workout session on each Day 3.
  • Washout Once a participant completes a study condition, participants will continue to take daily body weights at home for up to one week. Then participants will be required to wait one more week before completing their next condition during which they will resume regular diet and physical activity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Baseline Inclusion Criteria:

  • Weigh at least 110 lbs
  • Weight-Stable (2.5 kg) within the past six months
  • Height-Stable (< 0.25 inches) within the past year
  • 3 years of resistance training experience

Tested Inclusion Criteria:

  • <20% body fat (men) or <30% body fat (women)

Exclusion criteria

  • Lactose intolerant
  • Pregnancy
  • Taking interfering medications such as steroids, thyroid or growth hormones

Treatment and study plan

Caloric restriction

Other

Participants will consume 15 kcal/kg FFM/day.

Post-Exercise Protein

Dietary Supplement

Participants will ingest 30 g of protein following exercise.

Energy Balance

Other

Participants will consume 40 kcal/kg FFM/day.

Post-Exercise Carbohydrate

Dietary Supplement

Participants will ingest 30 g of carbohydrate following exercise.

Calcium and Vitamin D

Dietary Supplement

Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.

Primary outcomes

  1. Change in Serum [IGF-1] (ng/mL)

    Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

    Measured via ELISA

  2. Change in Serum [GH] (pg/mL)

    Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

    Measured via ELISA

  3. Change in Serum [IGFBP-3] (ng/mL)

    Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

    Measured via ELISA

  4. Change in Serum [P1NP] (pg/mL)

    Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

    Measured via ELISA

  5. Change in Serum [CTX] (ng/mL)

    Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

    Measured via ELISA

  6. Change in Serum [Sclerostin] (pmol/L)

    Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

    Measured via ELISA

Secondary outcomes

  1. Change in Body Weight (kg)

    Time frame: Baseline and Day 4

    Measured via Stadiometer

  2. Change in Body Fat Percentage (%)

    Time frame: Baseline and Day 4

    Measured via DXA and BIA

  3. Change in Perceived Hunger (mm or %)

    Time frame: Baseline and Day 4

    Measured on Visual Analog Scale within Survey

Sponsors and collaborators

Lead sponsor

University of Nebraska Lincoln

Other

Registry information

Official study title

Using Resistance Exercise and Protein Consumption to Protect Bone Health During Weight Loss

Acronym: RIDE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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