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| ID | Type | Description | Link |
|---|---|---|---|
| 22-925-E05-4065/Mack,Ang | Other Identifier | UT Martin |
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A cross-study analysis combined data from two sequential pre-post intervention studies conducted at the University of Tennessee at Martin, yielding a three-arm design comprising intermittent fasting alone (n = 16), clean ketogenic diet alone (n = 22), and combined clean ketogenic diet with intermittent fasting (n = 41). The clean ketogenic diet restricted carbohydrate intake to 20 grams per day from whole unprocessed sources and eliminated refined sugars, high-fructose corn syrup, and ultra-processed foods.
The intermittent fasting protocol employed a 16:8 time-restricted eating window. Paired-samples t-tests examined within-group pre-to-post changes. One-way analyses of variance with Tukey post-hoc comparisons examined between-group differences in magnitude of change. Effect sizes are reported as Hedges' g for within-group comparisons and eta-squared for between-group comparisons. An independent samples t-test compared glycosylated hemoglobin changes between the intermittent fasting and combined groups. Spearman and Kendall correlations examined associations between fat mass and cardiometabolic change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clean ketogenic Diet | Experimental | Participants ate low carb, under 20 g per day |
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| Intermittent fasting | Experimental | Participants went on a 16:8 feeding window |
|
| Clean keto and IF | Experimental | Combined Clean keto and intermittent fasting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | intervention was either clean keto, intermittent fasting 16:8 schedule or a combination of both |
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| Measure | Description | Time Frame |
|---|---|---|
| Concentration of HDL Cholesterol | Fasting Blood draw to assess high-density lipoprotein cholesterol levels | Baseline and 30 days |
| Concentration of Serum Triglycerides | Fasting blood draw to assess serum triglyceride levels | baseline and 30-days |
| Concentration of Hemoglobin A1c (HbA1c) | Blood draw to assess HbA1c as a marker of glycemic control | Baseline and 30 days |
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Inclusion Criteria:
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee at Martin | Martin | Tennessee | 38238 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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we will share all data and instruments, but we don't have a plan for an IPD right now
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2023 | Jun 10, 2026 |
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three arm design comparing 3 interventions (low carb, intermittent fasting, combined) between group design
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it was a blind study for the researcher who was analyzing the data
|
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2023 | Jun 10, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2023 | Jun 10, 2026 | ICF_002.pdf |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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